PMLS1

THE CLINICAL LABORATORY

- is the place where specimens (e.g. blood and other body fluids, tissues, feces, hair, nails) collected from individuals are processed, analyzed, preserved and properly disposed.

- varies according to size, function and the complexity of tests performed

Purpose of the Clinical Laboratory

- Detect disease or predisposition to disease

- Confirm or reject a diagnosis

- Establish prognosis

- Guide patient management

- Monitor efficacy of therapy

MEDICAL TECHNOLOGIST/ CLINICAL LABORATORY SCIENTIST

plays a very significant role in the performance of laboratory testing and ensuring the reliability of test results

According to Function

A. Clinical Pathology

B. Anatomic Pathology

A. Clinical Pathology

- Focuses on the following areas:

• Clinical Chemistry

• Immunohematology & Blood Banking

• Medical Microbiology • Immunology & Serology

• Hematology

• Parasitology

• Clinical Microscopy

• Toxicology

• Therapeutic Drug Monitoring &

• Endocrinology among others

A. Clinical Pathology

- Concerned with the diagnosis and treatment of disease through laboratory testing of blood and other body fluids.

B. Anatomic Pathology

- Focuses on the following areas:

• Histopathology

• Immunohistopathology

• Cytology • Autopsy

• Forensic Pathology among others

B. Anatomic Pathology

Concerned with the diagnosis and treatment of disease through microscopic examination of tissues and organs.

According to Institutional Characteristics

A. Institution- based

B. Free- standing

A. Institution- based

- a clinical laboratory that operates within the premises or part of an institution such as a:

• Hospital- most common example

• School

• Medical clinic

• Medical facility for overseas workers & seafarers

• Birthing home

• Psychiatric facility

• Drug rehabilitation center, etc.

B. Free- standing

- a clinical laboratory that is not part of an established institution such as a:

• Free- standing outpatient clinical laboratory- most common example

• Free- standing outpatient clinical laboratory-

most common example of Free- standing

According to Ownership

A. Government- owned

B. Privately- owned

A. Government- owned

- a clinical laboratory that is owned, partially or wholly, by national or local government units such as DOHrun government hospitals (e.g. Vicente Sotto Memorial Medical Center, Cebu City Medical Center, etc.)

B. Privately- owned

- a clinical laboratory that is owned, established, and operated by an individual, corporation, institution, association, or organization (e.g. Chong Hua Hospital, Cebu Doctors University Hospital, etc.)

According to Service Capability

A. Primary Category

B. Secondary Category

C. Tertiary Category

D. National Reference Laboratory (NRL)

A. Primary Category

a clinical laboratory that is licensed to perform basic, routine laboratory testing such as:

• Routine Urinalysis

• Routine Fecalysis • Routine Hematology or Complete Blood Count (hemoglobin, hematocrit, WBC & RBC count, WBC Differential count & qualitative platelet count)

• Blood Typing

• Gram Staining (if hospital- based)

A. Primary Category

Equipment requirements are, but not limited to:

• Microscopes

• Centrifuge

• Hematocrit centrifuge

A. Primary Category

Space requirement: at least 10 sqm.

B. Secondary Category

- a clinical laboratory that is licensed to perform laboratory tests being done by the primary category plus the following:

• Routine Clinical Chemistry (e.g. Blood glucose, Blood urea nitrogen, Blood uric acid, blood creatinine & cholesterol determination)

• KOH mount & Crossmatching (if hospital- based) - Equipment requirements are all equipment.

B. Secondary Category

Equipment requirements are all equipment requirements in a primary category plus the following:

• Semi- automated Chemistry analyzers

• Autoclave

• Incubator

• Oven

B. Secondary Category

- Space requirement: at least 20 sqm.

C. Tertiary Category

- a clinical laboratory that is licensed to perform laboratory tests being done by the secondary category plus the following:

• Immunology & Serology (e.g. NS1- Ag for dengue)

• Microbiology, Bacteriology & Mycology

• Special Clinical Chemistry (e.g. Clinical enzymology, TDM, Tumor Markers)

• Special Hematology (e.g. Bone marrow studies, , special staining for abnormal blood cells, etc.)

Equipment requirements are all equipment requirements in a secondary category plus the following:

• Automated Chemistry analyzer

• Biosafety cabinet Class II

• Serofuge, among others

C. Tertiary Category

Space requirement: at least 60 sqm.

D. National Reference Laboratory (NRL)

- a clinical laboratory in a government hospital designated by the DOH to provide the following:

● Referral services

● Provision of confirmatory testing

● Assistance for research activities

● Implementation of External Quality Assurance Program (EQAP)

● Resolution of conflicts regarding test results of different laboratories

● Training of medical technologists on certain specialized procedures that require standardization

San Lazaro Hospital (SACCL)

HIV and other STIs

East Avenue Medical Center

For Environmental and Occupational health; toxicology and micronutrient assay. 

National Kidney and Transplant Institute

Hematology, Immunohematology, Immunopathology, and Automated Urinalysis

Philippine Heart Center

Anatomic Pathology for Cardiac Disease

Lung Center of the Philippines

Anatomic Pathology and Clinical Chemistry (Biochemistry)

Research Institute for Tropical Medicine

Dengue, Influenza, TB, and other Mycobacteria, Malaria and other parasites, Bacterial enteric disease. Measles and other viral exanthems, mycology, enterovirus, antimicrobial resistance surveillance.

Clinical Chemistry

Testing blood and other bodily fluids to quantify essential soluble chemicals such as waste products. 

Clinical Chemistry

One of the most busiest sections, state-of-the-art, fully automated facility. 

Urine & Blood

The 2 most common fluids in the Clinical Chemistry

Clinical Chemistry

1. Fasting Blood Sugar (FBS) & Glycosylated Hemoglobin (HbA1c) 

2. HDL & LDL and Triglycerides (TAG)

3. Blood Uric Acid (BUA), Blood Urea Nitrogen (BUN) & Creatine 

4. Total Protein (TP), Albumin, Electrolytes (Na, K, Cl), etc.

Fasting Blood Sugar (FBS) & Glycosylated Hemoglobin (HbA1c) 

For the diagnosis of diabetes

HDL & LDL and Triglycerides (TAG)

can be used for the diagnosis pf cardiovascular diseases

Blood Uric Acid (BUA), Blood Urea Nitrogen (BUN) & Creatine

for the diagnosis of diseases involving the kidney

Microbiology

Subdivided into 4 sections:

1. Bacteriology

2. Mycobacteriology

3. Mycology

4. Virology

Microbiology

At present, this section is mor focused on the identification of bacteria and fungi on specimens received (usually blood and other fluids, stool, tissues, and swabs from different sites in the body)

Bacteriology

Culture & Sensitivity (C/S), Gram Staining (G/S), KOH

Mycobacteriology

mycobacterium identification (e.g. Mycobacterium tuberculosis)

Mycology

fungi identification only

Virology

virus identification

Hematology

Enumeration of cells in the blood and other bodily fluids (e.g. CSF, pleural fluid, etc.)

Hematology

Examinations done

1.CBC

2. Hemoglobin

3. Hematocrit

4. WBC differential count

5. Red cell morphology and cell indices

6. Quantitative platelet count

7. Total cell count and differential count

8. Blood smear preparation

9. Staining for other fluids

Clinical Microscopy

Two major areas:

1. Routine and special examinations of urine

2. Examinations of stool (routine fecalysis)

Blood bank / Immunohematology

Blood typing and Compatibility testing are the two main activities.

Blood bank / Immunohematology

Other test performed:

1. Antibodies screening and identification, blood components, preparation, for transfusion.

2. If hospital based laboratories:

Activities such as donor recruitment and screening bleeding for donor, post-donation care are also done

Immunology / Serology

Analyses of serum antibodies in certain infectious agents (primarily viral agents)

Immunology / Serology

Antigen and antibodies testing

Antibody Screening Test Examples

1. Hepatitis B profile test

2. Serological test for syphilis

3. Hepatitis C test 

4. Dengue Fever

Histopathology & Cytology

1. Tissue processing (removed surgically as in biopsy and autopsy)

2. Cutting into sections

3. Staining

4. Preparation for microscopic examination by a pathologist

Specialized sections

1. Immunochemistry

2. Molecular Biology and Biotechnology

Immunochemistry

• combines anatomical, clinical, and biochemical techniques where antibodies (monoclonal and polyclonal) bounded to enzymes and dyes are used to detect presence of antigens in tissue

• Useful in diagnosis of some types of cancers and certain neurodegenerative disorders, and assessment of patients' responses to cancer therapy

Molecular Biology and Biotechnology

• One of the exciting developments in medical technology

• DNA & RNA identification and detection of any pathologic conditions/disease (enzymes and reagent are used)

• Polymerase chain reaction (PCR) - most common technique currently in use

Polymerase chain reaction (PCR)

• most common technique currently in use in Molecular Biology and Biotechnology

LABORATORY TESTING CYCLE

• Encompasses all activities starting from a medical doctor writing a laboratory request up to the time (turn-around time [TAT]) the results are generated for treatment and management of patients.

• Medical technologists should have a clear understanding of the testing cycle to prevent erroneous test results

• Has three phases: Pre-analytic, analytic, and post-analytic

Pre-Analytical Phase

1. Laboratory Test Order/ Requisition

2. Order Reception

3. Patient Preparation

4. Specimen Collection

5. Specimen transport and Processing

Analytical Phase

1. Equipment and instruments

2. Quality or reagents used

3. Internal quality control program

Post-Analytical Phase

1. Data Transmission/ interpretation

2. Results Application

3. Turn-Around Time (TAT

LAWS ON THE OPERATION, MAINTENANCE, AND REGISTRATION OF CLINICAL LABORATORIES IN THE PHILIPPINES

• REPUBLICACT NO. 4688: Clinical Laboratory Act of 1966

• ADMINISTRATIVE ORDER NO. 59 s. 2001

Republic Act No. 4688 (Clinical Laboratory Law of 1966)

• Main Purpose: To regulate the operation and maintenance of clinical laboratories in the Philippines.

• Key Provisions:

  • All clinical laboratories must be registered and licensed by the Department of Health (DOH) before operation.

  • Laboratories are subject to regular inspection to ensure compliance with quality and safety standards.

  • Sets penalties for unauthorized operation of clinical laboratories.

  • Ensures the competence of laboratory personnel through regulation.

• Impact: Protects the public by ensuring that only accredited laboratories provide diagnostic testing.

Administrative Order No. 59, Series of 2001

(Implementing Rules and Regulations of RA 4688)

• Issued by DOH to operationalize RA 4688.

• Covers:

  • Licensing Requirements: Guidelines for application, renewal, and suspension of clinical lab licenses.

  • Technical Standards & Minimum Requirements:

    • Personnel: Laboratory must be headed by a licensed pathologist (or in some cases a licensed physician).

    • Facilities and Equipment: Minimum space, biosafety provisions, and required instruments per laboratory category (Primary, Secondary, Tertiary).

    • Quality Assurance: Participation in External Quality Assessment Programs (EQAP).

    • Record Keeping: Standardized reporting and documentation.

  • Service Capability:

    • Primary Labs: Basic tests (urinalysis, fecalysis, CBC, blood typing, Gram stain).

    • Secondary Labs: All primary tests + clinical chemistry, crossmatching, KOH prep.

    • Tertiary Labs: All secondary tests + special chemistry, microbiology, immunology/serology, blood banking.

    • National Reference Laboratories (NRL): Provide confirmatory testing, training, and EQAP services.

• Goal: Ensure patient safety, accuracy of results, and ethical laboratory practices.

SECTION 7:

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

SECTION 7: Requirements and Procedures for Application of Permit to Construct and License to Operate