NATURE OF CLINICAL LABORATORY Flashcards
Place where specimens (blood and other body fluids, tissues, feces, hairs, nail collected from individual are:
* processed
* analyzed
* preserves
* properly disposed
clinical laboratory
Classification of clinical laboratory
- function
- institutional characteristics
- ownership
- service capability
- concerned with the diagnosis and treatment of diseases performed through laboratory testing of blood and other body fluids
- Includes: clinical chem, immunohematology, medical microbiology, immunology and serology, hematology, parasitology, clinical microscopy, toxicology, therapeutic drug monitoring and endocrinology
clinical pathology
- concerned with the diagnosis of diseases through microscopic examination of tissues and organs
- includes: histopathology, immunohistopathology, cytology, autopsy, forensics pathology
anatomic pathology
deals with the analysis of:
* certain genes
* protein and
* 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 based on the principles, techniques, and tools of molecular biology as they are applied to diagnostic medicine in the laboratory
molecular pathology
- Operates within the premises or part of an institution such as hospital, school, medical clinic, medical facility for overseas workers and seafarers, birthing home, psychiatric facility, drug rehabilitation center and others
- hospital-based is the most common type
Institution based
- not part of an established institution
- the most common example is a free-standing out-patient clinical laboratory
Free standing
clinical laboratory owned, wholly or partially, by national or local govt units
government owned
clinical lab that are owned, established, and operated by an individual, corporation, institution, association, or organization
Private-owned
- licensed to perform basic, routine laboratory testing (routine urinalysis, stool examination, hematology or CBC [hemoglobin, hematocrit, WBC and RBC count, WBC differential count and qualitative platelet count, blood typing, and gram-straining if hospital-based])
- equipment (not limited to): microscopes, centrifuge, hematocrit centrifuge
- 10 sqm req
(clinical lab under) primary category
- licensed to perform laboratory tests being done by the primary category laboratories along with: routine chemistry tests like blood glucose concentration, blood urea nitrogen, blood uric acid, blood creatinine cholesterol determination, qualitative platelet count [hospital-based: gram strain, KOH mount, and crossmatching]
- equipment: microscope, centrifuge, hematocrit centrifuge, semi-automated chem analyzers, autoclave, incubator, oven
- 20 sq. m req
(Clinical lab under) second category, if hospital and non-hospital-based
- licensed to perform al lab test performed in the secondary lab + immunology and serology (Ns1-AG for dengue, rapid plasma reagin, treponema pallidum particle agglutination tests), microbiology, bacteriology, and mycology (differential staining techniques, culture and ID, and antimicrobial and susceptibility testing), special chem (clinical enzymology, therapeutic drug monitoring, makers for certain disease, special hematology), special hematology (bone marrow studies, special staining for abnormal cells, red cell morphology), immunohematology and blood banking (blood donation program, antibody screening and ID, prep of blood components)
- equip.: those in secondary category + automated chem analyzer, biosafety cabinet class II, serofuge
- 60 sq. m req
(clinical lab under) tertiary category, hospital, and non-hospital-based)
- laboratory in a govt hospital designated by the DOH to provide special diagnostic functions and services for certain diseases
- Referral services
- provision of confirmatory testing
- assistance for research activitties
- implementation of EQAP of the govt.
- Resolution of conflicts regarding test results of diff labs
- training of medtechs on certain specialized procedures that require standardization
National Reference Laboratory
- 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
- section 1 - registration and licensing
- section 2: laboratory should be headed by a fully registered physician
- section 3 - secretary of health, thru the BRI, now DOH - issuance of rules and regulations
- section 4 - punishment
- section 5 - if any section or part of this Act shall be adjudged by any court of competent jurisdiction to be invalid, the judgement shall not affect, impair or invalidate the remainder thereof
RA No. 4688
- section 1 - registration and licensing
- section 2: laboratory should be headed by a fully registered physician
- section 3 - secretary of health, thru the BRI, now DOH - issuance of rules and regulations
- section 4 - punishment
- section 5 - if any section or part of this Act shall be adjudged by any court of competent jurisdiction to be invalid, the judgement shall not affect, impair or invalidate the remainder thereof
RA No. 4688
When was RA 4688 approved?
June 18, 1966
- section 6 - the sum of 50k pesos, or so much thereof as may be necessary, in hereby authorized to be appropriated, out of any funds in the National Treasury not otherwise appropriated , to carry into effect the provisions of this Act
- section 7: all acts or part of acts which are inconsistent with the provisions of this Act are hereby repealed
- section 8: this Act shall take effect upon its approval
RA No 4688
Rules and regulation governing the Establishment, Operation, and Maintenance of Clinical Laboratories in the Philippines
Administrative (AO) No. 59, s. 2001
- section 1 - title
Rules and Regulation Governing the Establishment, Operation, and Maintenance of Clinical Laboratories in the Philippines
AO No. 59, s. 2001
- Section 2 - authority
DOH through the Bureau of Health Facilities and Services (BHFS) in the Health Regulation Cluster, shall exercise the regulatory functions under these rules and regulations
AO No. 59, s. 2001
- section 3 - Purpose
To protect and promote the health of the people by ensuring availability of clinical laboratories that are properly managed with adequate resources, with effective and efficient performance through compliance and quality standards
AO No. 59, s. 2001
section 4 - scope
* These regulations shall apply to all the entities performing the activities and functions of clinical laboratories
* do not include govt labs doing examinations limited to acid-fast bacilli microscopy, malaria screening and cervical cancer screening, provided their services are declared as extension of a licensed govt clinical lab
AO No. 59, s. 2001
According to this
Section 5 - Classification of Laboratories
1. Classification by function: Clinical pathology, anatomic pathology
2. Classification by institutional character: Hospital-based laboratory, non-hospital-based laboratory
3. Classification by Service Capability: Primary (routine hematology/urinalysis/fecalysis, blood typing, quantitative platelet determination[hospital-based]), secondary (primary + routine clinical chem, crossmatching)
AO No. 59, s. 2001
Section 6 - Policies
* an approved permit to construct and design layout of a clinical lab shall be secured from BHFS before application for Petition to Operate
* no clinical lab shall be constructed unless plans have been approved and construction permit issued by BHFS
* clinical lab shall operate with a valid license issued by BHFS/CHD based on compliance with the minimum licensing req (Annex A)
* clinical lab shall be recognized and managed to provide effective + efficient lab services
* the clinical lab shall provide adequate and appropriate safety practices for its personnel and clientele
AO No. 59, s. 2001
According to AO No. 59, s. 2001, this provides services for any of the ff but not limited to cytology and histopathology
Clinical lab for anatomic pathology only
According to AO No. 59, s. 2001, this provides services for genetics, immuno/hematopathology and infectious disease. COVID-19 testing lab shall be covered by another order
Clinical Lab for Molecular Pathology only
The laboratory shall be managed by a ________ certified by the Philippine Board of Pathology
Licensed Physician
At least ___ RMT per shift to cover lab operation
One (1)
- Well-ventilated, adequately lighted, clean and safe
- Working space shall be sufficient to accommodate its activities and allow smooth and coordinated workflow
- Adequate water supply
Physical facilities (technical standards and min. requirements)
Minimum space requirement for clinical lab in primary category
10 sq. m
Minimum space requirement for clinical lab in secondary category
20 sq. m
Minimum space requirement for clinical lab in tertiary category
60 sq. m
2 Quality Control program for technical standards and minimum requirements for a clinical laboratory
- Internal Quality Control Program
- External Quality Assurance Program
In terms of renewal of license of clinical lab, the rating given by the NRL should be at least _____
satisfactory performance
Refusal to participate in EQAP given by the designated NRL shall be one of the bases for ____/_____ of license of the lab
suspension/revocation
Laboratory requests shall be constructed as consultation between the requesting _____ and the ____ of the laboratory
Physician, pathologist
All lab reports shall bear the name of _____ and the _____
RMT, Pathologist
No person in the clinical lab shall issue a report, orally or in writing, whole or portions, thereof without the directive from the ______
pathologist
All lab records shall be kept on file for at least ______ year
one (1)
The laboratory fees to be charged for a lab exam shall be at ______ rates
prevailing
Requirement for application for Permit to Construct:
1. Letter of Application to the Director of _____
2. ____ sets of Site Development Plans and Floor Plans approved by an _____ and/or _____
3. ______ registration for private clinical lab
BHSF
four(4)
architect, engineer
DTI/SEC
According to section 7 - Requirement and Procedures for Application of Permit to Construct and License to Operate:
This is needed for application for _______:
* “petition to establish, operate and maintain a clinical lab” notarized application form
new license
According to section 7 - Requirement and Procedures for Application of Permit to Construct and License to Operate:
This is needed for application for _______:
* “application for renewal to establish, operate, and maintain a clinical lab” duly notarized application form
Renewal of License
According to section 7 - Requirement and Procedures for Application of Permit to Construct and License to Operate:
Application for renewal of license shall be filed within ____ before the expiry date of the license.
90 days
Schedule of application for renewal of license in NCR
Jan - March
Schedule of application for renewal of license in Region 1, 2, 3, & CAR
Feb - April
Schedule of application for renewal of license in Region 4, 5, 6
March - May
Schedule of application for renewal of license in Region 7, 8, 9
April - June
Schedule of application for renewal of license in Region 10, 11, 12, CARAGA, & ARMM
May - July
How much is the fee for late renewal of license (clinical lab)
Php 1,000
_______ shall be charged for an application received more than ____ months after expiry day
Php 100, and 2 (months)
According to section 7 - Requirement and Procedures for Application of Permit to Construct and License to Operate:
Clinical lab shall be inspected every _____ yrs or as necessary
2
According to section 7 - Requirement and Procedures for Application of Permit to Construct and License to Operate:
________ or his duly authorized representative shall be allowed to monitor the clinical lab
Director of the BHFS
According to section 7 - Requirement and Procedures for Application of Permit to Construct and License to Operate:
License is non-transferable
True or false?
True
According to section 7 - Requirement and Procedures for Application of Permit to Construct and License to Operate:
The owner or authorized representative of any clinical desiring to transfer a licensed clinical lab to another location shall inform the ____ in writing at least _ days before the actual transfer
CHD, 15 (days)
specialized section of the laboratory that combines anatomical, clinical, and biochemical techniques where antibodies (monoclonal and pylocyclonal) bounded to enzymes and fluourescents
Immunohistochemistry
- using diff enzymes and other reagents, DNA and RNA are identified and sequenced to detect any pathological conditions and disease processes
Molecular biology and biotechnology
- Encompasses all activities performed by the lab personnel to endure reliability of test results
- organized, systematic, well-planned, and regulary done with the result properly documented
Quality assurance
Provincial, city, and municipal are authorized to report to CHD and BHFs the existence of _____clinical lab
unlicensed
Imprisonment for not less than ____ month but not more than____ year or fine of not less than ____ and not more than 5k or both at the discretion of the court
One (month) , One (year), 1k
All clinical lab operating without a valid license whose license has been revoked/cancelled shall be summarily ____ upon order issues by the BHFS/CHD or his duly authorized representatiive
closed
Clinical lab personnel are?
pathologists, medtechs/clinical lab scientists, med technicians, phlebotomists, etc.
Section 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 (blood and urine)
Clinical chemistry
- more focused on the identification of bacteria and fungi on specimens received (blood and other body fluids, stool, tissues, and swabs from diff sites in the body
- sections: bacteriology, mycobacteriology, mycology, and virology
Microbiology
- This section deals with the enumeration of cells in the blood and other body fluids (e.g., CSF, pleural fluid, etc.)
- coagulation studies focus on blood testing for the determination of various coagulation factors
Hematology and Coagulation Studies
- composed of 2 major areas:
1st: allotted to routine and other special examination of urine such as macroscopic examinations to determine color, transparency, specific gravity, and pH level, and microscopic examination to detect presence of abnormal cells (examination of other body fluids is also included)
2nd: assigned to examination of stool or routine fecalysis (detection and identification of parasitic worms and ova are the primary activities in this area)
Clinical Microscopy
- blood typing and compatibility testing are the two main activities performed in this section
- screening for all antibodies and identification of antibodies as well as the blood components used for transfusion are also conducted in this section
- section considered as the most critical in the clinical lab
Blood bank/immunohematology
- analyses of serum antibodies in certain infectious agents (primarily viral agents) are performed in this section
- Hepatitis B profile tests, serological test for syphilis, and tests for hepatitis C and dengue fever are some examples of antibody screening tests
Immunology and serology
Activities performed in this section include:
* tissue (removed surgically as in biopsy and autopsy)
* processing
* cutting into sections
* staining, and
* preparation for microscopic by a pathology
section of histopathology/cytology
An extension laboratory shall have a _________
separate license
Any change affecting substantial conditions of the license to operate a lab shall be reported within ___ days in writing by the person/s concern to the BHFS/CHD for notation and approval
15
Suspension/revocation of license upon violation to RA 4688: operation of a clinical lab without a certified ______ or without a ____
pathologist, RMT
Suspension/revocation of license upon violation to RA 4688: change in ownership, location, head of the lab/personnel without informing the _______ and/or the _______
BHFS, CHD
Suspension/revocation of license upon violation to RA 4688: refusal to allow inspection of the clinical lab by the person/s authorized by the ____ during reasonable hour
BHFS
it is a specialized section of the lab that combines anatomical, clinical, and biochemical techniques where antibodies (monoclonal and polyclonal) bounded to enzymes and fluorescent dyes are used to detect the presence of antigens in tissue
Immunohistochemistry
- one of the exciting developments in medical technology
- primarily using diff enzymes and other reagents, DNA and RNA are identified and sequenced to detect any pathologic conditions/disease processes
- PCR
Molecular Biology and Biotechnology
Encompasses all activities starting from a medical doctor writing a lab requesting up to the time (TAT) the results are generated and become useful information for the treatment and management of patients
Laboratory Testing Cycle
3 phases of lab testing cycle?
- pre-analytic
- analytic
- post-analytic
Includes the receipt of the lab request, patient preparation, specimen collection, and proper transport and processing of specimen to the clinical lab
pre-analytic
deals with the actual testing of the submitted/collected specimen. Important consideration should be given to the equipment and instrument used, reagents, and internal quality control program
analytic phase
includes the transmission of test results to the medical doctor for interpretation, TAT, and application for doctor’s recommendations. The diagnosis and treatment are based on generated data
post-analytic phase
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 Asssurance (QA)
- Includes day-to-day activities that are undertaken in order to control factors or variables that may affect test results
- regular review and audits of results are done in order to identify weaknesses and consequently perform corrective actions
Internal Quality Assurance System r(IQAS)
- a system for checking performance among clinical lab and is facilitated by designated external agencies
Esternal Quality Assurance System (EQAS)
Is the DOH-designated EQAS
National Reference Laboratories (NRL)
National Kidney and Transplant Institute (NKTI) is the NRL-EQAS for?
Hematology and Coagulation
Research Institute of Tropical Medicine (RITM) is teh NRL-EQAS for?
Microbiology (identification and antibiotic susceptibility testing, and parasitology (identification of ova and quantitation of malaria)
Lung Center of the Philippines (LCP) is the NRL-EQAS for?
Clinical chemistry (testing 10 analytes, namely glucose, creatinine, total protein, albumin, blood urea nitrogen, uric acid, cholesterol, sodium, potassium, and chloride)
East Avenue Medical Center (EAMC) is the NRL-EQAS for?
drugs of abuse (methamphetamine and cannabinoids)
