Clinical Laboratory Act

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RA 4688

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37 Terms

1

RA 4688

Clinical Laboratory Act is also known as what RA?

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June 18, 1966

RA 4688 was approved on

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Bureau of Health Facilities and Services

BHFS

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Center for Health Development

CHD

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Department of Health

DOH

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External Quality Assurance Program

EQAP

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License to Operate

LTO

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National Reference Laboratory

NRL

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  • Classification by Ownership

  • Classification by Functions

  • Classification by Institutional Character

  • Classification by Service Capability

Classification of Laboratory

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  1. Clinical Pathology

  2. Anatomic Pathology

Classification by Function

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Clinical Pathology

Hematology, Clinical Chemistry, Microbiology, Parasitology, Mycology, Clinical Microscopy, Immunology and Serology, Blood banking, Endocrinology and Toxicology

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Anatomic Pathology

Surgical Pathology, Immunopathology, Cytology, Autopsy and Forensic Pathology

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  1. Hospital Based Laboratory

  2. Non-Hospital Based Laboratory

Classification by Institutional Character

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Hospital Based Laboratory

A laboratory that operates within a hospital.

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Non-Hospital Laboratory

A laboratory that operates on its own

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  1. Primary Laboratory

  2. Secondary Laboratory

  3. Tertiary Laboratory

Classification by Service Capability

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Primary Laboratory

  • Routine Hematology, Routine urinalysis and Fecalysis,

  • Qualitative platelet determination

  • Blood typing can be done in a hospital based laboratory.

  • Centrifuge, Hemacytometer, Microhematorit centrifuge, Microscope, Hemoglobinometer, Diff count counter

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Special Clinical Laboratory

a lab that offers highly specialized lab services that are usually not provided by gen clin lab. Molecular.

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Secondary Laboratory

  • Provides the minimum service capabilities or primary with addition of the following:

  1. Quantitative Platelet determination

  2. Routine Clinical Chemistry

  3. Gram staining & KOH (Hospital based Lab)

  4. Cross matching (hospital based laboratory)

  • Refrigerator, spectrophotometer, water bath, timer

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Tertiary Laboratory

  • Provides the Secondary capabilities with the following laboratory test

  1. Special Chemistry

  2. Special Hematology

  3. Immunology and serology

  4. Microbiology

  • Incubator, Analytical balance, Rotator, Serofuge, Autoclave, Drying oven, Biosafety cabinet

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two (2) years

Clinical laboratory shall be inspected every ___ or as necessary

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Notice of Violation

___ for non compliant shall be issued immediately after monitoring by CHD, forwarded to BHFS

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NO LTO

If the reason is due to ___ has been issued, the provincial, city and municipal health officers are enjoined by BHFS to explain for the existence of colorum as part of their duties and responbility

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licensed physician certified by the Philippine Board of Pathology

The clinical laboratory shall be managed by a ___

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three months

In areas where pathologist is not available a physician with ___ training on clinical laboratory medicine, quality control and laboratory management may manage a primary or secondary category clinical laboratory.

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one

There should be at least ___ Medical Technologist.

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AO 201, 4

Based on ___, pathologist are authorized to supervise of how many clinical lab/BB.

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2

1 MT can only supervise ___ MLT at one time

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800 tests/ per month / MT

Manual method

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10 square meter

Minimum working space requirement for Primary Laboratory

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20 square meter

Minimum working space requirement for Secondary Laboratory

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60 square meter

Minimum working space requirement for Tertiary Laboratory

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  • Internal Quality Control

  • External Quality Control

Quality Control Program

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Pathologist

No person in clinical laboratory shall issue a report orally or in writing, whole or portions, thereof without a directive from ___

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1 year

All requests and results in duplicate original copy will be filed as part of patients medical record) shall be kept in file for at least ___

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permanently

Records on anatomic and forensic pathology shall be kept ___ in laboratory.

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