Clinical Laboratory Flashcards by Nicole Eirylle

Is the place where specimens collected from individual are processed, analyzed, preserved, and properly disposed

Clinical laboratory

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RA 4688 is aka

Clinical Laboratory Law

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Classification of Clinical Laboratories

clinical pathology and anatomic pathology

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Administrative Order no. 37 series of 2021 states that?

laboratories can be classified according to 3
classification of function (Clinical Pathology,
Anatomic Pathology and Molecular Pathology)

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According to RA 4688 or the Clinical Laboratory Law, laboratories can be classified into two:

Clinical pathology, anatomic pathology

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A clinical lab that focuses on the areas that is concerned with diagnosis of diseases through microscopic examination of tissues and organs

Anatomic pathology

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It is concerned with the diagnosis and treatment of diseases performed through lab testing of body fluids

Clinical pathology

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Analysis of genetic content and proteins
Other molecules in samples from
organs, tissues or bodily fluids in
order to diagnose disease and/or to
guide the prevention and treatment
of disease

Molecular Pathology

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Classification of lab acc to institutional characteristics

Institution-based, free standing

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Clinical lab that operates within the premises or part of an institution

Institution-based

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Clinical lab that is not part of an established institution

Free-standing

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Classification of clinical lab acc to Ownership

Government-owned and Privately-owned

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Clinical lab that are owned, wholly or partially by national or local government units

Government-owned

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Clinical lab are owned, established, and operated by an institution, corporation, organization, or association

Privately-owned

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Classification of clinical lab acc to service capability

Primary category, secondary category, tertiary category, and national reference laboratory

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Basic, routine lab testing
- routine urinalysis
- routine stool examination
- routine hematology or complete blood count

equipments:
Microscope
-Centrifuge
-Hematocrit centrifuge

Primary category

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Licensed to perform lab tests being done by the primary category lab along with:
- routine chemistry tests
- cross matching

equipments:
- Microscopes
- Centrifuge
- Hematocrit centrifuge
- Semi-automated chemistry analyzers
- Autoclave (sterilize glasswares)
- Incubator

Secondary category

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Gram stain is done in which type of lab?

Bacteriology

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Are licensed to perform all the lab tests performd in the secondary category plus;
- immunology and serology (infection)
- microbiology, bacteriology, mycology
- special chemistry

Tertiary category

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Minimum Floor requirement for primary, secondary, and tertiary category

Primary - 10 square meters
Secondary - 20
Tertiary - 60

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Equipments include microscopes, centrifuge, hematocrit centrifuge are what type of category?

Primary category

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Lab in a government hospital designated by the DOH to provide special diagnostic functions and services for certain diseases

National Reference Laboratory

An act regulating the operation and maintenance of clinical lab and requiring th registration of the same with the department of health (DOH) providing penalty for the violation thereof, and for other purposes.

RA 4688

● Section _ - Registration and Licensing
● Section 2- Lab should be headed by a duly
________ _________
● Section 3- Secretary of Health, through the Bureau of research and lab (RBL), now
____ -Issuance of rules and regulations
● Section 4- ______
- Imprisonment for not less than ONE MONTH but NOT MORE THAN ONE YEAR
- Fine of NOT LESS THAN 1K nor
MORETHAN5K
● Section 5- If any section or part of this Act
shall be adjusted by any court of competent
jurisdiction to be invalid, the judgment shall
not affect, impair or invalidate the remainder
thereof
Approval date: _______

1; REGISTERED PHYSICIAN; DOH; PUNISHMENT; June 18, 1966

Rules and Regulation Governing the Establishment, Operation and Maintenance of Clinical Laboratories in the Philippines

ADMINISTRATIVE ORDER NO 59 S 2001

An approved ______ to construct and Design layout of a clinical laboratory shall be secured from the BHFS prior to submission of an application for a Petition to Operate

PERMIT

A clinical Laboratory shall operate with a valid ______ issued by BHFS/Center Health Development (CHD), based on compliance with the minimum licensing requirements (ANNEX A)

LICENSE

Application for renewal of license shall be files WITHIN __ DAYS or ___ Months before the expiry date of the license described as follows:

90; 3

Penalties - ______ Pesos for late renewal - ______ Pesos will be charged for an application received more than 2 months after expiry date

1K; 100

Clinical Laboratory shall be inspected every ___ years or as necessary

representative of any clinical desiring to transfer a licensed clinical laboratory to another location shall inform the CHD in WRITING AT LEAST __ DAYS before the actual transfer

An extension laboratory shall have a _____ LICENSE

separate

The following acts committed by the Owner, President, Managers, Board of Trustees/Directors, Pathologist, or personnel are considered VIOLATIONS: a. Operation of a clinical lab without a certified pathologist or without a ____ b. Change in location, ownership, head of the laboratory, or personnel without informing the BHFS and/or the CHD. c. Refusal to allow inspection of the clinical lab by the person(s) authorized by the BHFS during reasonable hours. d. Gross negligence. e. Any act or omission detrimental to the public.

RMT

The laboratory shall be managed by a _______ _______ certified by the Philippine Board of ______

LICENSED PHYSICIAN; PATHOLOGY

At least __ RMT per shift to cover laboratory operations

a. There shall be a documented, continuous competency assessment program for all laboratory personnel. b. The program shall provide appropriate and standard laboratory methods, reagents, supplies, and equipment. c. There shall be a program for the proper maintenance and monitoring of all equipment. d. The program shall provide for the use of quality control reference materials

Internal quality control program

a. All clinical laboratories shall participate in an External Quality Assurance Program provided by designated National Reference Laboratories and/or other recognized reference laboratories. b. A satisfactory performance rating given by a National Reference Laboratory shall be one of the criteria for the renewal of the license. c. Any refusal to participate in an External Quality Assurance Program given by the designated National Reference Laboratories shall be one of the bases for suspension/revocation of the laboratory's license.

External Quality Control Program

All laboratory reports on various examinations of specimens shall bear the name of the ______ and the _____ and duly signed by both.

RMT; Pathologist

This section is intended for the testing of blood and other body fluids to quantify essential soluble chemicals, including waste products, useful for the diagnosis of certain diseases.

clinical chemistry

This section deals with the enumeration of cells in the blood and other body fluids

hematology

focus on blood testing for the determination of various coagulation factors

coagulation studies

**CLINICAL MICROSCOPY** This section comprise two areas: ● ____ analysis and other body fluids (Physical exam, Chemical:Glucose, protein and bacteria, Microscopic) ● Examination of stool or routine _____

Urine, fecalysis

Blood typing and compatibility testing are the two main activities performed in this section.

blood bank

Screening for all ANTIBODIES and identification of antibodies as well as. blood components used for transfusion are also conducted.

Immunohematology

Analyses of SERUM ANTIBODIES in certain infectious agents (primarily viral agents) are performed in this section

serology

- a specialized section of the laboratory that combines anatomical, clinical, and biochemical techniques where antibodies (monoclonal and polyclonal) bounded to enzymes and fluorescent dyes are used to detect presence of antigens in tissue. - useful in the diagnosis of some types of cancers

IMMUNOHISTOCHEMISTRY

Using different enzymes and other reagents, DNA and RNA are identified and sequenced to detect\ any pathologic conditions/disease processes. The most common technique currently in use is the ________

polymerase chain reaction

________ phase includes the receipt of the laboratory request, patient preparation specimen collection, and proper transport and processing of specimen to the clinical laboratory.

pre-analytic

deals with the actual testing of the submitted/collected specimen. Important consideration should be given to equipment and instruments used, reagents, and internal quality control program

analytic phase

phase includes the transmission of test results to the medical doctor for interpretation, TAT, and application of doctor's recommendations. The diagnosis and treatment are based on the generated data.

post-analytic

- Encompasses all activities performed by laboratory personnel to ensure reliability of test results. - It is organized, systematic, well planned and regularly done with the results properly documented and consistently reviewed

Quality Assurance

includes day-to-day activities that are undertaken in order to control factors or variables that may affect test results. Regular review and audit of results are done in order to identify weaknesses and consequently perform corrective actions

IQAS (Internal Quality Assurance System

a system for checking performance among clinical laboratories and is facilitated by designated external agencies.

EQAS (External Quality Assurance System)

The National Reference Laboratories (NRL) is the DOH-designated ____. An unknown sample with known test results is regularly sent to a clinical laboratory for testing

EQAS