CLINICAL LABORATORY AND ITS ORGANIZATIONAL STRUCTURE (APPLICATION, LICENSING, RENEWAL AND INSPECTION) Flashcards by Reigne Escopete

Q

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.

A

REPUBLIC ACT NO. 4688

CLINICAL LABORATORY ACT OF 1966

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What is R.A 4688

A

CLINICAL LABORATORY ACT OF 1966

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Q

What is the date of approval of the REPUBLIC ACT NO. 4688

A

Approved on June 18, 1966

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Q

IMPLEMENTING RULES AND REGULATIONS (DOH):
Rules and Regulations Governing the
Establishment, Operation and Maintenance of
Clinical Laboratories in the Philippines

A

A.O.

59-2001

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Q

IMPLEMENTING RULES AND REGULATIONS (DOH):
Revised Rules and Regulations Governing the
Licensure and Regulation of Clinical Laboratories
in the Philippines

A

A.O.

27-2007

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Q

Institution based laboratory is owned by the ___

A

Government

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Q

Free Standing laboratory is owned by the ___

A

Private Institution

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Q

The function of the Government Laboratory

A

Clinical

Pathology

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Q

The function of the Private owned laboratory

A

Anatomic

Pathology

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Q

Service Capability of a Government owned laboratory

A

General

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Q

Service Capability of a Private owned laboratory

A

Special

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Q

What type of pathology handles:

•Clinical Chemistry

A

CLINICAL PATHOLOGY

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Q

What type of pathology handles:

•Hematology

A

CLINICAL PATHOLOGY

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Q

What type of pathology handles:

•Immunohematology (Blood Banking)

A

CLINICAL PATHOLOGY

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Q

What type of pathology handles:

•Microbiology

A

CLINICAL PATHOLOGY

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Q

What type of pathology handles:

•Immunology and Serology

A

CLINICAL PATHOLOGY

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Q

What type of pathology handles:

•Clinical Microscopy

A

CLINICAL PATHOLOGY

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Q

What type of pathology handles:

• Endocrinology

A

CLINICAL PATHOLOGY

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Q

What type of pathology handles:

•Molecular Biology

A

CLINICAL PATHOLOGY

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Q

What type of pathology handles:

•Cytogenetics

A

CLINICAL PATHOLOGY

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Q

What type of pathology handles:

• Toxicology

A

CLINICAL PATHOLOGY

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Q

What type of pathology handles:

• Therapeutic Drug Monitoring

A

CLINICAL PATHOLOGY

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Q

What type of pathology handles:

•Surgical Pathology

A

ANATOMIC PATHOLOGY

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Q

What type of pathology handles:

•Immunohistopathology

A

ANATOMIC PATHOLOGY

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What type of pathology handles: | •Cytology

ANATOMIC PATHOLOGY

What type of pathology handles: | •Autopsy

ANATOMIC PATHOLOGY

What type of pathology handles: | •Forensic Pathology

ANATOMIC PATHOLOGY

What type of pathology handles: | •Molecular Pathology

ANATOMIC PATHOLOGY

What type of general clinical laboratory handles: | ▪Routine Hematology

Primary

What type of general clinical laboratory handles: ▪All the services provided by the PRIMARY CLINICAL LABORATORY

Secondary

▪All the services provided by the SECONDARY CLINICAL LABORATORY

Tertiary

``` ▪ Provides particular service only IN AN INSTITUTION Example: - Dialysis Centers - Social Hygiene clinics ```

Limited Services

What type of general clinical laboratory handles: | ▪Routine Urinalysis

Primary

What type of general clinical laboratory handles: | ▪Routine Fecalysis

Primary

What type of general clinical laboratory handles: ▪Blood typing (hospital-based)

Primary

What type of general clinical laboratory handles: ▪Qualitative Platelet Count

Primary

What type of general clinical laboratory handles: | ▪Routine Clinical Chemistry

Secondary

What type of general clinical laboratory handles: | • Fasting Blood Sugar (FBS)

Secondary

What type of general clinical laboratory handles: •Kidney Function test (Urea, Creatinine & Uric Acid)

Secondary

What type of general clinical laboratory handles: | ▪ Quantitative Plate count

Secondary

What type of general clinical laboratory handles: ▪Crossmatching (hospital-based)

Secondary

What type of general clinical laboratory handles: | ▪KOH (hospital-based)

Secondary

What type of general clinical laboratory handles: ▪Gram staining (hospital-based)

Secondary

What type of general clinical laboratory handles: | Special Chemistry

Tertiary

What type of general clinical laboratory handles: | ▪ Special Hematology

Tertiary

What type of general clinical laboratory handles: | ▪Immunology

Tertiary

What type of general clinical laboratory handles: | ▪Culture and Sensitivity

Tertiary

What type of general clinical laboratory handles: •Aerobic and Anaerobic (hospital-based)

Tertiary

What type of general clinical laboratory handles: •Aerobic or Anaerobic (non hospital-based)

Tertiary

Offers Highly Specialized Services like: a) Genetics laboratory b) DNA c) Molecular Biology laboratory

SPECIAL

No need to secure License to Operate (LTO) otherwise stipulated by the law.

SPECIAL

Only __________R.A. 7719 has license

Immunohematology (Blood Banking)

______ supervises the clinical laboratory; in absence any physician trained and authorized by _____

Pathologist, DOH

Must be a graduate of medicine

Pathologist

Residency for Pathology Laboratory: | Clinical Pathology

2 years

Residency for Pathology Laboratory: | Anatomic Pathology

3 years

Residency for Pathology Laboratory: | Forensic Pathology

In camp crame

The pathologist must pass the ____(both written and practical)

Board of Pathology Exam

Three (3) month training by the DOH regarding:

1. Laboratory management 2. Quality Assurance (QA) 3. Quality Control (QC)

Pathologist: ___in any category, or 3 ______ and 1 ______

4 clinical laboratories, 3 clinical laboratories and 1 blood bank

Physician: | _______either primary or secondary

1 clinical laboratory

They give out license to operate

•Department of Health – Bureau of Health Facilities & Services (DOH-BHFS)

what is the meaning of

DOH-BHFS

LTO is valid to for how many year/s?

1 year

EXEMPTIONS IN SECURING LICENSE TO OPERATE FROM BHFS: Laboratories operated and maintained exclusively for ______ and _______ purposes

research and teaching

EXEMPTIONS IN SECURING LICENSE TO OPERATE FROM BHFS: Special clinical laboratories operating _______ of clinical laboratories

independently

EXEMPTIONS IN SECURING LICENSE TO OPERATE FROM BHFS: ______ office Laboratory

Physician’s

All government laboratories are exempted in LTO when they are performing microscopy works for______,_______ and __________

a. Malarial screening b. Acid-Fast Bacteria (AFB) Screening c. STD screening

CONSIDERATIONS IN LTO ISSUANCE: | Clinical Laboratory and its satellite in the ___________

same compound

CONSIDERATIONS IN LTO ISSUANCE: | Satellite laboratory ________ the premises of central laboratory

outside

CONSIDERATIONS IN LTO ISSUANCE: | __________ laboratory

mobile

where should they renew the LTO

regional in Center for Health Development (CHD) or in the DOH-BHFS

May start to renew their license in ____ days before expiration (last day of the year – December 31)

90

What are the inspection done by the DOH-BHFS in the laboratory

Quality Assurance Programs ✔ Internal Quality Control Program ✔ Internal Quality Assurance Program ✔ Continuous Quality Improvement Program ✔ External Quality Assurance Program (EQAP) by NRL – National Reference Laboratory ✔ International External Quality Assurance Program (EQAP) by The Joint Commission (TJC) and College of American Pathologist (CAP)

what type of National Reference Laboratory does: | Bacteriology

Research Institute for Tropical | Medicine (RITM)

what type of National Reference Laboratory does: | Parasitology

Research Institute for Tropical | Medicine (RITM)

what type of National Reference Laboratory does: | Mycobacteriology

Research Institute for Tropical | Medicine (RITM)

what type of National Reference Laboratory does: | Transfusion Transmitted Infection (TTI)

Research Institute for Tropical | Medicine (RITM)

what type of National Reference Laboratory does: | Hematology

National Kidney and Transplant | Institute (NKTI)

what type of National Reference Laboratory does: | Clinical Chemistry

Lung Center of the Philippines | LCP

what type of National Reference Laboratory does: | Drug Test

EAST AVENUE MEDICAL | CENTER

what type of National Reference Laboratory does: | Water Bacteriology

EAST AVENUE MEDICAL | CENTER

what type of National Reference Laboratory does: | HIV testing

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

what type of National Reference Laboratory does: | HBV testing

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

what type of National Reference Laboratory does: | HCV testing

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

what type of National Reference Laboratory does: | Syphilis testing

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