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mt 11 lec > [7] the clinical laboratory > Flashcards

[7] the clinical laboratory Flashcards

1
Q

this is the place where specimens collected from individuals are processed, analyzed, preserved, and properly disposed.

A

the clinical laboratory

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2
Q

what are the main tasks in the clinical laboratory?

A

▪ Provide accurate and reliable information
▪ Involved in research, community outreach programs, surveillance, infection control in the hospital and community setting, information dissemination, and evaluation of the applicability of current and innovative diagnostic technologies

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3
Q

Clinical laboratories vary according to?

A

size, function, and complexity of tests performed

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4
Q

what are the classifications of clinical laboratories?

A
  1. According to function
  2. According to institutional characteristics
  3. According to ownership
  4. According to service capability
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5
Q

what are the types of laboratory according to function?

A
  1. Clinical Pathology
  2. Anatomic Pathology
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6
Q

This type of lab is concerned with the diagnosis and treatment of diseases performed through laboratory testing of blood and other body fluids

A

Clinical Pathology

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7
Q

What areas does a Clinical Pathology lab focus on?

A

a. Clinical Chemistry
b. Immunohematology and blood banking
c. medical microbiology
d. immunology and serology
e. parasitology
g. clinical microscopy (AUBF)
h. toxicology
i. therapeutic drug monitoring

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8
Q

This type of lab is concerned with the diagnosis of diseases through microscopic examination of tissues and organs

A

Anatomic Pathology

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9
Q

what areas does an anatomic pathology lab focus on?

A

a. Histopathology
b. Immunohistopathology
c. Cytology
d. Autopsy
e. Forensic pathology

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10
Q

what are the types of lab according to institutional characteristics?

A
  1. institution-based
  2. free-standing
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11
Q

This type of clinical laboratory operates within the premises or part of an institution

list the institutions (7) and which one is the most common example of this lab

A

Institution-based

a. hospital (most common example)
b. school
c. medical clinic
d. medical facility for overseas workers and seafarers
e. birthing homes
f. psychiatric facility
g. drug rehabilitation center

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12
Q

this type of clinical laboratory is not part of an established institution

what is the most common example of this lab?

A

Free-standing

most common example is a freestanding out-patient clinical laboratory

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13
Q

what are the types of labs according to ownership?

A
  1. Government-owned
  2. Privately-owned
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14
Q

What clinical laboratories are owned, wholly or partially, by national or local government units?

Give general examples (2)

A

Government-owned

Anatomical and clinical labs of
a. DOH-run government hospitals
b. local government run hospital-based laboratories

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15
Q

Give 3 examples of DOH-run government hospitals

A
  • San Lazaro Hospital
  • UP-PGH
  • JRRMMC
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16
Q

Give 3 examples of local government run hospital-based laboratories

A
  • Ospital ng Maynila Medical Center
  • Sta. Ana Hospital
  • Bulacan Medical Center
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17
Q

what clinical laboratories are owned, established, and operated by an individual, corporation, institution, association, or organization?

Give examples (2)

A

Privately-owned

  • St. Luke’s Medical Center
  • MakatiMed
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18
Q

what are types of labs according to service capability?

A
  1. primary category
  2. secondary category
  3. tertiary category
  4. National Reference Laboratory
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19
Q

according to service capability

This category of lab is licensed to perform basic, routine laboratory testing and provides the minimum service capabilities

A

primary category

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20
Q

according to service capability

what do primary category labs provide?

A

▪ Routine hematology or complete CBC includes hemoglobin, hematocrit, WBC count, differential count, qualitative platelet determination
▪ Routine UA
▪ Routine fecalysis
▪ Blood typing

If hospital-based:
▪ Blood typing
▪ Qualitative platelet determination

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21
Q

according to service capability

what are the equipment requirements of primary category labs?

what about space requirement?

A

Equipment requirements are,* but not limited* to:
▪ Microscopes
▪ Centrifuge
▪ Hematocrit centrifuge

at least 10 square meters

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22
Q

according to service capability

this category of lab is licensed to perform laboratory tests being done by the primary category clinical laboratories along with routine clinical chemistry tests

A

Secondary category (Hospital and non-hospital based)

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23
Q

according to service capability

What are routine clinical chemistry tests performed in secondary category labs?

aside from primary category clinial laboratory tests

if hospital-based?

A
  • Blood glucose concentration
  • BUN
  • BUA
  • Blood creatinine
  • Cholesterol determination
  • Qualitative platelet count *

*quali platelet count is in primary pero naa mn syas table so idrk

  • Gram stain
  • KOH mount
  • Crossmatching
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24
Q

according to service capability

what is the minimum equipment requirements for secondary category labs? (7)

what about the minimum requirement for floor area?

A
  • microscope
  • centrifuge
  • hematocrit centrifuge
  • semi-automated chemistry analyzers
  • autoclave
  • incubators
  • oven

20 square meters

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25
Q

according to servive capability

what category of lab performs all the laboratory tests done in the secondary category laboratory plus… ?

Give the additional general lab tests performed in this category (5)

A

Tertiary category (hospital and non-hospital-based)

a. immunololgy and serology
b. Microbiology, bacteriology, and mycology
c. Special clinical chemistry
d. Special hematology
e. Immunohematology and blood banking

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26
Q

according to service capability

what are the specific lab tests under immunology and serology? (3)

in tertiary category

A
  • NS1-Ag for dengue
  • Rapid plasma reagin
  • Treponema pallidum particle agglutination tests
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27
Q

according to service capability

what are the specific lab tests under Microbiology, bacteriology, and mycology? (3)

in tertiary category

A
  • Differential staining techniques
  • Culture and identification of bacteria and fungi from specimens
  • AST
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28
Q

according to service capability

what are the specific lab tests under Special clinical chemistry? (3)

in tertiary category

A
  • Clinical enzymology
  • TDM
  • Markers for certain diseases
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29
Q

according to service capability

what are the specific lab tests under Special hematology? (3)

in tertiary category

A
  • Bone marrow studies
  • Special staining for abnormal blood cells
  • Red cell morphology
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30
Q

according to service capability

what are the specific lab tests under Immunohematology and blood banking? (3)

in tertiary category

A
  • Blood donation program
  • Antibody screening and identification
  • Blood component preparation
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31
Q

according to service capability

this type of lab is a laboratory in a government hospital designated by the DOH to provide special diagnostic function and services for certain diseases

give an example of this lab

give the functions of this lab (6)

A

national reference laboratory

san lazaro (?) katong gi say ni maam lera abt HIV but i forgor mb:(

a. Referral services
b. Provision of confirmatory testing
c. Assistance for research activities
d. Implementation of External Quality Assurance Programs (EQAP) of the government
e. Resolution of conflicts regarding test results of different laboratories
f. Training of medical technologists on certain specialized procedures that require standardization

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32
Q

laws on the operation, maintenance, and registration of clinical laboratories in the philippines

A

RA 4688
AO 59 S. 2001

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33
Q

this is also known as “Clinical Laboratory Law”

A

Republic Act No. 4688

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34
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 thereof, and for other purposes.

A

Republic Act No. 4688

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35
Q

what is in Section 1 of RA 4688?

what should a lab haver/owner do?

A

Any person, firm or corporation, operating and maintaining a clinical laboratory in which body fluids, tissues, secretions, excretions and radioactivity from beings or animals are analyzed for the determination of the presence of pathologic organisms, processes and/or conditions in the persons or animals from which they were obtained, shall register and secure a license annually at the office of Secretary of Health

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36
Q

what is in Section 2 of RA 4688?

who should be in charge of the lab?

A

A licensed physician duly qualified in laboratory medicine shall be professionally in-charge of the registered clinical laboratory

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37
Q

what is in Section 3 of RA 4688?

functions of the secretary of health thru the bureau… (2)

A

The Secretary of Health through the Bureau of Research and Laboratories has the following functions:

▪Responsible for strictly enforcing the provisions of RA 4688
▪Authorized to issue rules and regulations as deemed necessary to carry out the provisions

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38
Q

what is in Section 4 of RA 4688?

what is the punishment for the violation of RA 4688?

A

Violation of the Act or the rules and regulations stipulated shall be punished with:

▪ Imprisonment for not less than one month but not more than one year
▪ A fine of not less than one thousand pesos nor more than five thousand pesos
▪Or both at the discretion of the court

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39
Q

when was RA 4688 approved?

A

Approved, June 18, 1966

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40
Q

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

A

Administrative Order No. 59 s. 2001

(AO 59 S. 2001)

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41
Q

what is in Section 2. of AO 59 S. 2001?

AUTHORITY. wdym by authority? who has authority?

A

▪ Redirection of the Functions and Operations of the Department of Health
▪ The** DOH through the Bureau of Health Facilities and Services (BHFS) in the Health Regulation Cluster**, shall exercise the regulatory functions and regulations.

42
Q

what is in Section 3. of AO 59 S. 2001?

PURPOSE. what is the purpose of these rules?

A

The rules and regulations are promulgated to protect and promote the health of the people by ensuring the availability of clinical laboratories that are properly managed with adequate resources, with effective and efficient performance through compliance with quality standards.

43
Q

what is in Section 4. of AO 59 S. 2001?

SCOPE. what/where/who do these rules apply to?

A

1.Regulations apply to all entities performing the activities and functions of clinical laboratories

2.These regulations do not include government laboratories doing laboratory examinations limited to acid fast bacilli microscopy, malaria screening and cervical cancer screening, provided that their services are declared as extension of a licensed government clinical laboratory

44
Q

what is in Section 7. of AO 59 S. 2001?

general (9)

A

Requirements and Procedures for Applications of Permit to Construct and License to Operate

  1. Application for Permit to Construct
  2. Application for New License
  3. Application for renewal of license
  4. Permit and License Fee
  5. Penalties
  6. Inspection
  7. Monitoring
  8. Issuance of License
  9. Terms and Conditions of License
45
Q

Section 7. of AO 59 S. 2001

what are the required documents to apply for a permit to construct? (3)

1. Application for Permit to Construct

A

The following are the documents required:
a. Letter of application to the Director of BHFS
b. Four (4) sets of Site Development Plans and Floor Plans approved by an architect and/or engineer.
c. DTI/SEC Registration (for private clinical laboratory)

46
Q

Section 7. of AO 59 S. 2001

what should the owner/rep file in order to apply for a NEW license? where?

2 . Application for New License

A

**A duly notarized application form “Petition to Establish, Operate and Maintain a Clinical Laboratory”, shall be filed by the owner or his duly authorized representative at the BHFS.

47
Q

Section 7. of AO 59 S. 2001

what should the owner/rep file in order to apply for RENEWAL of license? where?

3 . Application for renewal of license

A

A duly notarized application form “Application for Renewal of License to Establish, Operate and Maintain a Clinical Laboratory” shall be filed by the owner or his duly authorized representative at the respective CHD.

48
Q

Section 7. of AO 59 S. 2001

When should the application for renewal of license be filed?

3 . Application for renewal of license

give the schedule of application for license renewal for each region.

A

Application for renewal of license shall be filed within 90 days before the expiry date of the license

  • NCR (January to March)
  • 1, 2, 3, CAR (February to April)
  • 4, 5, 6 (March to May)
  • 7, 8, 9 (April to June)
  • 10, 11, 12, CARAGA, ARMM (May to July)
49
Q

Section 7. of AO 59 S. 2001

What type of fees are charged for applying for or renewing a permit or license? how much will be paid?

4 . Permit and License Fee

Where should all fees be paid?
What schedule or guidelines are followed for these fees?

A

a. A non-refundable license fee shall be charged for application for permit to construct, and for license to operate a government and private clinical laboratory.
(to construct: primary-1k, secondary-1.1k, tertiary-1.3k)
(license: primary-2.5k, secondary-3k, tertirary-3.5k)

b. A non-refundable fee shall be charged for application for renewal of license to operate.
(renewal: primary-2k, secondary-2.5k, tertiary-3k)

c. All fees shall be paid to the Cashier of the BHFS/CHD.

d. All fees shall follow the current prescribed schedule of fees of the DOH.

50
Q

Section 7. of AO 59 S. 2001

How much is the late renewal fee? How many months after the expiry date until penalty?

5 . Penalties

Is there an additional fine if application is late beyond given (grace-period?) months after the expiry date?

A

▪ One thousand pesos shall be charged for late renewal in addition to the renewal fee for all categories if the application is filed during the next two (2) months after the expiry date.

▪ An application received more than two (2) months after expiry date shall be fined one hundred pesos for each month there after in addition to P1,000.00 penalty.

51
Q

Section 7. of AO 59 S. 2001

Who can inspect the premises and facilities of a licensed laboratory? What must a licensed laboratory provide for inspection?

6 . Inspection

How often are clinical laboratories inspected?

A

▪ Each license shall make available to the director of BHFS/CHD or his duly authorized representative at any reasonable time, the premises and facilities where the laboratory examinations are being performed for inspection.

▪ Each license shall make available to the director of BHFS/CHD or his duly authorized representative all pertinent records.

▪ Clinical laboratories shall be inspected every two (2) years or as necessary

52
Q

Section 7. of AO 59 S. 2001

How often are clinical laboratories monitored?
Who is allowed to monitor clinical laboratories/when can they monitor the labs?

7 . Monitoring

What must clinical laboratories provide for monitoring?

A

▪All clinical laboratories shall be monitored regularly, and records shall be made available to determine compliance with these rules and regulations.

▪The Director of the BHFS/CHD or his authorized representative(s) shall be allowed to monitor the clinical laboratory at any given time.

▪ All clinical laboratories shall make available to the Director of the BHFS or his duly authorized representative(s) records for monitoring.

53
Q

Section 7. of AO 59 S. 2001

Who issues the license?

8 . Issuance of License

A

License is issued by the Director of the CHD

54
Q

Section 7. of AO 59 S. 2001

What must an owner do before transferring a clinical laboratory to another location?

What happens to a clinical laboratory when it moves to a new location?

9 . Terms and Conditions of License

Is the license for a clinical laboratory transferable?

A

▪ An owner of a clinical laboratory desiring to transfer a licensed CL to another location shall inform the CHD in writing at least 15 days before the actual transfer

▪ The CL in its new location shall be subjected to re-inspection and shall comply with the licensing requirements

▪ Non-transferable

55
Q

Section 7. of AO 59 S. 2001

Does an extension laboratory need a separate license?
Where should the clinical laboratory license be displayed?

9 . Terms and Conditions of License

A

▪ An extension laboratory shall have a separate license

▪ The license must be placed in a conspicuous location/area within the laboratory.

56
Q

what is in Section 8 of AO 59 S. 2001?

VIOLATIONS. what happens? what r considered violations?

A
  1. The LTO of a CL shall be suspended or revoked by the Secretary of Health
  2. The following are considered as violations:
    ▪ Operation of a CL without a certified pathologist or without an RMT
    ▪ Change of ownership, location, head of the CL or personnel without informing the BHFS/CHD
    ▪ Refusal to allow inspection of CL by the persons authorized by BHFS during reasonable hours.
    ▪ Gross negligence
    ▪ Any act or omission detrimental to the public
57
Q

annex A

whats under annex A? (5)

A

technical standards and minimum requirements

  • staffing
  • physical facilities
  • quality control program
  • reporting
  • recording
58
Q

annex A

who should manage the clinical laboratory?

staffing

A

A licensed physician certified by the Philippine Board of Pathology shall manage the clinical laboratory

*doesnt necessarily have to be a pathologist, can be ANY physician as long as certified by the board of pathology – i think also dapat ni agi silag med lab training for 3months

59
Q

annex A

What are the requirements for staffing in a clinical laboratory, including the number and availability of RMTs?

STAFFING

How many RMTs should be present per shift in a hospital-based clinical laboratory?

A

▪ Enough RMTs proportional to the workload

▪ RMTs must be always available during hour of laboratory operation

▪ For hospital-based clinical lab., at least one RMT per shift should be
present to cover the laboratory operation

60
Q

annex A

What program is required to upgrade the knowledge, attitude, and skills of staff in a clinical laboratory?

STAFFING

A

There should be staff development and continuing education program to upgrade the knowledge, attitude, and skills of staff

61
Q

annex A

what are the requirements of physical facilities of labs?

PHYSICAL FACILITIES

what is the minimum working space (measurements) for all categories of clinical laboratories? ennumerate.

A
  • Well-ventilated, adequately lighted, clean, and safe
  • Working space shall be sufficient to accommodate its activities and allow for smooth and coordinated workflow
  • Adequate water supply

Primary (10)
Secondary (20)
Tertiary (60)

62
Q

annex A

2 types of Quality Assurance Programs

QUALITY CONTROL PROGRAM

A
  1. Internal Quality Control Program
  2. External Quality Control Program
63
Q

annex A

What are the requirements for clinical laboratories in the Internal Quality Assurance Program?

QUALITY CONTROL PROGRAM

A

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

64
Q

What are the requirements for clinical laboratories in the External Quality Assurance Program?

A

a. All clinical laboratories shall participate in an External Quality Assurance Program given by designated NRL 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 license.
c. Any refusal to participate in an EQAP given by designated NRL shall be one of the bases for suspension/revocation of the license of the laboratory.

65
Q

annex A

Who must sign laboratory reports, and when can results be released without a pathologist’s directive?

REPORTING

A
  1. All laboratory reports on various examinations of specimens shall bear the name of the RMT and the pathologist and duly signed by both.
  2. No person in the clinical laboratory shall issue a report, orally or in writing, whole or portions thereof without a directive from the pathologist or his authorized associate to the requesting physician or his authorized representative except in emergency cases when the results may be released as authorized by the pathologist.
66
Q

annex A

What system must be in place to ensure accurate recording and storage of laboratory requests and reports?

RECORDING

A

There shall be a system of accurate recording to ensure quality results.
1.There shall be an adequate and effective system of recording requests and reports of all specimens submitted and examined.
2.There shall be provisions for filing, storage, and accession of all reports
3. All laboratory records shall be kept on file for at least one (1) year.
* Records of anatomic and forensic pathology shall be kept permanently in the laboratory.

67
Q

sections in the clinical laboratory

This section tests blood and other body fluids to
quantify essential soluble chemicals including waste products for disease diagnosis

what are the two most common body fluid subjected for analyses in this section?

A

clinical chemistry

Blood and Urine

68
Q

sections in the clinical laboratory

What tests are performed in the clinical chemistry section? (10)

A
  • fasting blood sugar (FBS)
  • Glycosylated hemoglobin (HbA1c)
  • Total cholesterol including high- and low-density lipoproteins
  • Triglycerides (TAG)
  • Blood uric acid
  • Creatinine
  • Total protein (TP)
  • Albumin
  • Electrolytes (Sodium, potassium, chloride)
  • Clinical enzymology (aminotransferase, creatine kinase)
69
Q

sections in the clinical laboratory

Considered to be one of the busiest sections, in terms of the number of tests performed.

A

Clinical Chemistry

70
Q

sections in the clinical laboratory

In majority of tertiary level clinical laboratories, it is characterized as a state-of-the-art, fully automated facility

A

Clinical Chemistry

71
Q

sections in the clinical laboratory

this section is subdivided into four sections: bacteriology, mycobacteriology, mycology, and virology

what are the specimens processed in this section?

A

Microbiology

  • blood and body fluids
  • stool
  • tissues
  • swabs from different sites in the body
72
Q

sections in the clinical laboratory

what tests are included in microbiology?

what else

A

a. Microscopic visualization of microorganisms after staining, isolation, and ID of bacteria and fungi using varied culture media and biochemical tests
b. Antigen typing
c. Antibacterial susceptibility testing
d. Preparation of culture media and stains
e. Quality assurance and quality control
f. Infection control and biosafety and proper waste disposal

  • gram stain reactions (gram posivite/gram negative)
  • mixed culture
  • antimicrobial susceptibility testing
  • biochemical testing
73
Q

sections in the clinical laboratory

in this section, automated instruments are available such as those used for blood culture and antimicrobial
susceptibility testing.

A

Microbiology

74
Q

sections in the clinical laboratory

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

what examinations are done in this section?

A

Hematology and Coagulation Studies

  • CBC
  • hemoglobin
  • hematocrit
  • WBC differential count
  • red cell morphology
  • red cell indices
  • quantitative platelet count
  • blood smear preparation, and staining
75
Q

sections in the clinical laboratory

  • [____________________] focus on blood testing for the determination of various coagulation factors
  • [____________________] are currently available in the market
A
  • Coagulation Studies
  • Automated hematology analyzers
76
Q

sections in the clinical laboratory

this section has two major areas:
1. Urinalysis (Routine and special examinations)
2. Fecalysis (Stool examination)

give the tests under each area

A

Clinical Microscopy

1. Urinalysis (Routine and special examinations)
* Macroscopic examination: color and transparency, volume
* Chemical examination: pH, osmolarity, protein, urea, creatinine, glucose
* Microscopic examination: detect presence of abnormal cells and/or parasites as well as to quantify RBCs and WBCs

2. Fecalysis (Stool examination)
* Detection and identification of parasitic worms and ova

77
Q

sections in the clinical laboratory

most critical section the clinical laboratory

what tests are performed in this sections? (5)

A

Blood Bank/Immunohematology

▪Blood typing
▪Compatibility testing
▪Antibody screening and identification
▪Blood component preparation

▪Blood donation activities
-Donor recruitment
-Bleeding of donor
-Post donation care

78
Q

sections in the clinical laboratory

Tests in this section include:
* Analyses of serum antibodies in certain infectious agents
* Hepatitis B profile tests
* Serological tests for syphilis
* Tests for Hepatitis C
* Tests for Dengue

A

Immunology and Serology

79
Q

sections in the clinical laboratory

Activities include tissue processing, sectioning, staining, and preparation for microscopic examination by a pathologist.

ANATOMIC PATHOLOGY

A

Histopathology/Cytology

80
Q

sections in the clinical laboratory

what are specialized sections of the laboratory? (2)

A
  1. Immunohistochemistry
  2. Molecular Biology and Biotechnology
81
Q

sections in the clinical laboratory

This section combines anatomical, clinical, and biochemical methods, utilizing antibodies bound to enzymes and fluorescent dyes to detect the presence of antigens in tissue. It is particularly useful in diagnosing certain types of cancer by identifying tumor-specific antigens, oncogenes, and tumor suppressor genes, as well as assessing patients’ responses to cancer therapy and diagnosing specific neurodegenerative disorders.

specialized sections of the laboratory

A

Immunohistochemistry

82
Q

sections of the clinical laboratory

This section involves identification and sequencing of DNA and RNA using various enzymes and reagents is employed to detect pathological conditions or disease processes, with PCR being the most common technique used. This method is particularly useful for screening genetic indicators of disease, as well as diagnosing cancer and infectious diseases.

specialized sections of the laboratory

A

Molecular Biology and Biotechnology

83
Q

Encompasses all activities starting from a medical doctor writing a laboratory request up to the time the results are generated and become useful information for the treatment and management of patients

what are the three phases?

A

Laboratory Testing Cycle

a. pre-analytic
b. analytic
c. post-analytical

84
Q

laboratory testing cycle

This phase includes the receipt of the laboratory request, patient preparation, specimen collection and proper transport, and processing of specimen

A

Pre-Analytic Phase

85
Q

laboratory testing cycle

This phase 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

A

Analytic Phase

86
Q

laboratory testing cycle

Transmission of test results to the medical doctor for interpretation, TAT, and application of doctor’s recommendations. Diagnosis and treatment are based on the generated data.

A

Post-analytic Phase

87
Q

what is the cycle ?

A

lab test requisition/order —> order reception —> patient preperation, specimen collection —> specimen transport & processing —> actual processing —> data transmission/interpretation, results appliaation TAT

pre-analytic —> analytic —> post-analytic

88
Q

errors in pre-analytic phase

A

Errors may occur in:
a. preparation of the request slip for the patient
b. transportation
c. processing in the clinical laboratory
d. physiologic factors
e. identification of patients and labeling of specimens
f. anticoagulant used, volume of specimen collected, and volume of anticoagulant

89
Q

errors in analytic phase

A
  • Errors in the equipment and instruments
  • Quality of reagents used
90
Q

errors in post-analytic phase

A
  • Transcription errors (wrong value used, results given to the wrong patient)
91
Q

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

A

Quality Assurance

92
Q

QUALITY ASSURANCE IN THE CLINICAL LABORATORY

2 major components

A
  • Internal Quality Assurance System (IQAS)
  • External Quality Assurance System (EQAS)
93
Q

QUALITY ASSURANCE IN THE CLINICAL LABORATORY

  • Includes day-to-day activities that are undertaken to control factors or variables that may affect test results
  • Regular review and audit of results are done
A

Internal Quality Assurance System (IQAS)

94
Q

QUALITY ASSURANCE IN THE CLINICAL LABORATORY

  • A system for checking the performance among clinical laboratories
  • Facilitated by designated external agencies such as National Reference Laboratories (NRL) – DOH-designated EQAS
  • An unknown sample with known test results is regularly sent to a clinical laboratory for testing and results are then returned to the external facility and are compared with the known result
A

External Quality Assurance System (EQAS)

95
Q

DESIGNATED NRL-EQAS

  • Hematology
  • Immunohematology
  • Urinalysis
  • Anatomic Pathology for Renal Diseases
A

National Kidney and Transplant Institute (NKTI)

96
Q

DESIGNATED NRL-EQAS

  • Tuberculosis
  • Transfusion-Transmissible Infections
  • Influenza and other respiratory viruses
  • Mycology
A

Research Institute of Tropical Medicine (RITM)

97
Q

DESIGNATED NRL-EQAS

  • Clinical Chemistry (for testing 10 analytes namely: glucose, creatinine, total protein, albumin, blood urea nitrogen, uric acid, cholesterol, sodium, potassium, and chloride)
  • Anatomic pathology for pulmonary and pleural diseases
A

Lung Center of the Philippines (LCP)

98
Q

DESIGNATED NRL-EQAS

  • Toxicology/Drugs of abuse (methamphetamine and cannabinoids)
  • Micronutrient assay
  • Environment and occupational health
A

East Avenue Medical Center (EAMC)

99
Q

DESIGNATED NRL-EQAS

  • HIV/AIDS
  • Hepatitis B and Hepatitis C
  • Syphilis and other STIs
A

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

100
Q

DESIGNATED NRL-EQAS

  • Anatomic pathology for cardiac diseases
  • Cardiac markers
A

Philippine Heart Center (PHC)

mt 11 lec (2 decks)

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