[7] the clinical laboratory Flashcards
(100 cards)
1
Q
this is the place where specimens collected from individuals are processed, analyzed, preserved, and properly disposed.
A
the clinical laboratory
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
3
Q
Clinical laboratories vary according to?
A
size, function, and complexity of tests performed
4
Q
what are the classifications of clinical laboratories?
A
- According to function
- According to institutional characteristics
- According to ownership
- According to service capability
5
Q
what are the types of laboratory according to function?
A
- Clinical Pathology
- Anatomic Pathology
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
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
8
Q
This type of lab is concerned with the diagnosis of diseases through microscopic examination of tissues and organs
A
Anatomic Pathology
9
Q
what areas does an anatomic pathology lab focus on?
A
a. Histopathology
b. Immunohistopathology
c. Cytology
d. Autopsy
e. Forensic pathology
10
Q
what are the types of lab according to institutional characteristics?
A
- institution-based
- free-standing
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
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
13
Q
what are the types of labs according to ownership?
A
- Government-owned
- Privately-owned
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
15
Q
Give 3 examples of DOH-run government hospitals
A
- San Lazaro Hospital
- UP-PGH
- JRRMMC
16
Q
Give 3 examples of local government run hospital-based laboratories
A
- Ospital ng Maynila Medical Center
- Sta. Ana Hospital
- Bulacan Medical Center
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
18
Q
what are types of labs according to service capability?
A
- primary category
- secondary category
- tertiary category
- National Reference Laboratory
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
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
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
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)
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
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
25
# according to servive capability
what category of lab performs all the laboratory tests done in the secondary category laboratory plus... ?
## Footnote
Give the additional general lab tests performed in this category (5)
Tertiary category (hospital and non-hospital-based)
## Footnote
a. immunololgy and serology
b. Microbiology, bacteriology, and mycology
c. Special clinical chemistry
d. Special hematology
e. Immunohematology and blood banking
26
# according to service capability
what are the specific lab tests under immunology and serology? (3)
| in tertiary category
* NS1-Ag for dengue
* Rapid plasma reagin
* Treponema pallidum particle agglutination tests
27
# according to service capability
what are the specific lab tests under Microbiology, bacteriology, and mycology? (3)
| in tertiary category
* Differential staining techniques
* Culture and identification of bacteria and fungi from specimens
* AST
28
# according to service capability
what are the specific lab tests under Special clinical chemistry? (3)
| in tertiary category
* Clinical enzymology
* TDM
* Markers for certain diseases
29
# according to service capability
what are the specific lab tests under Special hematology? (3)
| in tertiary category
* Bone marrow studies
* Special staining for abnormal blood cells
* Red cell morphology
30
# according to service capability
what are the specific lab tests under Immunohematology and blood banking? (3)
| in tertiary category
* Blood donation program
* Antibody screening and identification
* Blood component preparation
31
# 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
## Footnote
give the functions of this lab (6)
national reference laboratory
| san lazaro (?) katong gi say ni maam lera abt HIV but i forgor mb:(
## Footnote
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
32
laws on the operation, maintenance, and registration of clinical laboratories in the philippines
RA 4688
AO 59 S. 2001
33
this is also known as “Clinical Laboratory Law”
Republic Act No. 4688
34
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.
Republic Act No. 4688
35
what is in Section 1 of RA 4688?
| what should a lab haver/owner do?
**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**
36
what is in Section 2 of RA 4688?
| who should be in charge of the lab?
A **licensed physician duly qualified in laboratory medicine** shall be professionally in-charge of the registered clinical laboratory
37
what is in Section 3 of RA 4688?
| functions of the secretary of health thru the bureau... (2)
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
38
what is in Section 4 of RA 4688?
| what is the punishment for the violation of RA 4688?
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
39
when was RA 4688 approved?
Approved, June 18, 1966
40
Rules and Regulation Governing the Establishment, Operation, and Maintenance of Clinical Laboratories in the Philippines
Administrative Order No. 59 s. 2001
| (AO 59 S. 2001)
41
what is in Section 2. of AO 59 S. 2001?
| **AUTHORITY.** wdym by authority? who has authority?
▪ **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
what is in Section 3. of AO 59 S. 2001?
| **PURPOSE.** what is the purpose of these rules?
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
what is in Section 4. of AO 59 S. 2001?
| **SCOPE.** what/where/who do these rules apply to?
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
what is in Section 7. of AO 59 S. 2001?
## Footnote
general (9)
Requirements and Procedures for Applications of Permit to Construct and License to Operate
## Footnote
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
# 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
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
# 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 **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
# 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 **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
# Section 7. of AO 59 S. 2001
When should the application for renewal of license be filed?
| 3 . Application for renewal of license
## Footnote
give the schedule of application for license renewal for each region.
Application for renewal of license shall be filed **within 90 days before the expiry date** of the license
## Footnote
* 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
# 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
## Footnote
Where should all fees be paid?
What schedule or guidelines are followed for these fees?
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)**
## Footnote
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
# 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
## Footnote
Is there an additional fine if application is late beyond given (grace-period?) months after the expiry date?
▪ **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
# 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
## Footnote
How often are clinical laboratories inspected?
▪ 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**.
## Footnote
▪ Clinical laboratories shall be inspected **every two (2) years or as necessary**
52
# 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
## Footnote
What must clinical laboratories provide for monitoring?
▪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**.
## Footnote
▪ All clinical laboratories shall make available to the Director of the BHFS or his duly authorized representative(s) **records for monitoring**.
53
# Section 7. of AO 59 S. 2001
Who issues the license?
| 8 . Issuance of License
License is issued by the **Director of the CHD**
54
# 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
## Footnote
Is the license for a clinical laboratory transferable?
▪ 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**
## Footnote
▪ **Non-transferable**
55
# 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
▪ An extension laboratory shall have a **separate license**
▪ The license must be placed in a **conspicuous location/area within the laboratory**.
56
what is in Section 8 of AO 59 S. 2001?
| **VIOLATIONS.** what happens? what r considered violations?
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
annex A
## Footnote
whats under annex A? (5)
technical standards and minimum requirements
## Footnote
* staffing
* physical facilities
* quality control program
* reporting
* recording
58
# annex A
who should manage the clinical laboratory?
| staffing
A **licensed physician certified by the Philippine Board of Pathology** shall manage the clinical laboratory
## Footnote
*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
# annex A
What are the requirements for staffing in a clinical laboratory, including the number and availability of RMTs?
| STAFFING
## Footnote
How many RMTs should be present per shift in a hospital-based clinical laboratory?
▪ Enough RMTs proportional to the workload
▪ RMTs must be always available during hour of laboratory operation
## Footnote
▪ For hospital-based clinical lab., at least one RMT per shift should be
present to cover the laboratory operation
60
# annex A
What program is required to upgrade the knowledge, attitude, and skills of staff in a clinical laboratory?
| STAFFING
There should be **staff development and continuing education program** to upgrade the knowledge, attitude, and skills of staff
61
# annex A
what are the requirements of physical facilities of labs?
| PHYSICAL FACILITIES
## Footnote
what is the minimum working space (measurements) for all categories of clinical laboratories? ennumerate.
* 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
## Footnote
Primary (10)
Secondary (20)
Tertiary (60)
62
# annex A
2 types of Quality Assurance Programs
| QUALITY CONTROL PROGRAM
1. Internal Quality Control Program
2. External Quality Control Program
63
# annex A
What are the requirements for clinical laboratories in the Internal Quality Assurance Program?
| QUALITY CONTROL PROGRAM
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
What are the requirements for clinical laboratories in the External Quality Assurance Program?
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
# annex A
Who must sign laboratory reports, and when can results be released without a pathologist's directive?
| REPORTING
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
# annex A
What system must be in place to ensure accurate recording and storage of laboratory requests and reports?
| RECORDING
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
# sections in the clinical laboratory
This section tests blood and other body fluids to
quantify essential soluble chemicals including waste products for disease diagnosis
## Footnote
what are the two most common body fluid subjected for analyses in this section?
clinical chemistry
## Footnote
Blood and Urine
68
# sections in the clinical laboratory
What tests are performed in the clinical chemistry section? (10)
* 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
# sections in the clinical laboratory
Considered to be one of the busiest sections, in terms of the number of tests performed.
Clinical Chemistry
70
# sections in the clinical laboratory
In majority of tertiary level clinical laboratories, it is characterized as a state-of-the-art, fully automated facility
Clinical Chemistry
71
# sections in the clinical laboratory
this section is subdivided into four sections: bacteriology, mycobacteriology, mycology, and virology
## Footnote
what are the specimens processed in this section?
Microbiology
## Footnote
* blood and body fluids
* stool
* tissues
* swabs from different sites in the body
72
# sections in the clinical laboratory
what tests are included in microbiology?
## Footnote
what else
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
## Footnote
* gram stain reactions (gram posivite/gram negative)
* mixed culture
* antimicrobial susceptibility testing
* biochemical testing
73
# sections in the clinical laboratory
in this section, automated instruments are available such as those used for blood culture and antimicrobial
susceptibility testing.
Microbiology
74
# sections in the clinical laboratory
This section deals with the enumeration of cells in the blood and other body fluids
## Footnote
what examinations are done in this section?
Hematology and Coagulation Studies
## Footnote
* CBC
* hemoglobin
* hematocrit
* WBC differential count
* red cell morphology
* red cell indices
* quantitative platelet count
* blood smear preparation, and staining
75
# sections in the clinical laboratory
* [____________________] focus on blood testing for the determination of various coagulation factors
* [____________________] are currently available in the market
* Coagulation Studies
* Automated hematology analyzers
76
# sections in the clinical laboratory
this section has two major areas:
1. Urinalysis (Routine and special examinations)
2. Fecalysis (Stool examination)
## Footnote
give the tests under each area
Clinical Microscopy
## Footnote
**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
# sections in the clinical laboratory
most critical section the clinical laboratory
## Footnote
what tests are performed in this sections? (5)
Blood Bank/Immunohematology
## Footnote
▪Blood typing
▪Compatibility testing
▪Antibody screening and identification
▪Blood component preparation
▪Blood donation activities
-Donor recruitment
-Bleeding of donor
-Post donation care
78
# 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
Immunology and Serology
79
# sections in the clinical laboratory
Activities include tissue processing, sectioning, staining, and preparation for microscopic examination by a pathologist.
| ANATOMIC PATHOLOGY
Histopathology/Cytology
80
# sections in the clinical laboratory
what are specialized sections of the laboratory? (2)
1. Immunohistochemistry
2. Molecular Biology and Biotechnology
81
# 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
Immunohistochemistry
82
# 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
Molecular Biology and Biotechnology
83
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
## Footnote
what are the three phases?
Laboratory Testing Cycle
## Footnote
a. pre-analytic
b. analytic
c. post-analytical
84
# laboratory testing cycle
This phase includes the receipt of the laboratory request, patient preparation, specimen collection and proper transport, and processing of specimen
Pre-Analytic Phase
85
# 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
Analytic Phase
86
# 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.
Post-analytic Phase
87
what is the cycle ?
**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
errors in pre-analytic phase
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
errors in analytic phase
* Errors in the equipment and instruments
* Quality of reagents used
90
errors in post-analytic phase
* Transcription errors (wrong value used, results given to the wrong patient)
91
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.
Quality Assurance
92
# QUALITY ASSURANCE IN THE CLINICAL LABORATORY
2 major components
* Internal Quality Assurance System (IQAS)
* External Quality Assurance System (EQAS)
93
# 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
Internal Quality Assurance System (IQAS)
94
# 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
External Quality Assurance System (EQAS)
95
# DESIGNATED NRL-EQAS
* Hematology
* Immunohematology
* Urinalysis
* Anatomic Pathology for Renal Diseases
National Kidney and Transplant Institute (NKTI)
96
# DESIGNATED NRL-EQAS
* Tuberculosis
* Transfusion-Transmissible Infections
* Influenza and other respiratory viruses
* Mycology
Research Institute of Tropical Medicine (RITM)
97
# 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
Lung Center of the Philippines (LCP)
98
# DESIGNATED NRL-EQAS
* Toxicology/Drugs of abuse (methamphetamine and cannabinoids)
* Micronutrient assay
* Environment and occupational health
East Avenue Medical Center (EAMC)
99
# DESIGNATED NRL-EQAS
* HIV/AIDS
* Hepatitis B and Hepatitis C
* Syphilis and other STIs
San Lazaro Hospital STD-AIDS Cooperative Central Laboratory (SACCL)
100
# DESIGNATED NRL-EQAS
* Anatomic pathology for cardiac diseases
* Cardiac markers
Philippine Heart Center (PHC)
