CH2 (Part 2) - The Laboratory in the Health System

What is AO 59 s. 2001?

What is AO 59 s. 2001?

"Rules and regulations governing the establishment, operation and maintenance of clinical laboratories in the Philippines."

What is a Blood Bank?

A lab/institution able to recruit and screen blood donors

Able to collect, process, store, transport and issue blood for transfusion.

Able to provide information/education on blood transmissible disease.

What are Blood Collection Units?

An institution/facility duly authorized by the DOH to recruit and screen donors and collect blood.

What does East Avenue Medical Center cover as an NRL?

Environmental Health

Occupational Health

Toxicology

Micronutrient Assay

What does the Lung Center of the Philippines cover as an NRL?

Biochemistry

What is RA 4688?

"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."

When was RA 4688 approved?

June 18, 1966

When was AO 59 s. 2001 effective?

November 19, 2001

What is AO 2007-27?

"Revised rules and regulations governing the licensure and regulation of clinical laboratories in the Philippines."

When was AO 2007-27 effective?

August 22, 2007

Define clinical laboratory

"A place equipped for making tests or doing experimental work for examination of materials derived from the human body for the purpose of providing information on diagnosis, prognosis, prevention, or treatment of disease."

What are the two classifications of ownership?

Government

Private

What are the two classifications by function?

Clinical Pathology

Anatomic Pathology

In classification by function, what does Clinical Pathology include?

Hematology

Clinical Chemistry

Microbiology

Clinical Microscopy

Immunology & Serology

Immunohematology

Blood Banking

Laboratory Endocrinology

Molecular Biology

Cytogenetics

Toxicology & Therapeutic Drug Monitoring

In classification by function, what does Anatomic Pathology include?

Surgical pathology

Immunohistopathology

Cytology

Autopsy and forensic pathology

Molecular pathology

What are the two classifications of Institutional Characteristics?

Institution-based laboratory

Non-hospital-based laboratory

What is included in an Institution-based laboratory?

Operates within an institution such as a hospital, school, psychiatric facility, drug rehab center

What is included in a non-hospital-based laboratory?

A lab that operates on its own (ex. Physician's office lab)

What are the two classifications of Service Capability?

General Clinical Laboratory

Special Clinical Laboratory

There are four classifications in General Clinical Laboratory. What are they?

Primary

Secondary

Tertiary

Limited Service Capability (institution-based only)

Under the General Primary classification, what are the minimum service capabilities?

Routine CBC

UA

Fecalysis

Qualitative platelet determination (blood-typing for hospital-based)

Under the General Secondary classification, what services are offered?

Routine clinical chemistry

Quantitative platelet determination (Glucose, BUN, BUA, Creatinine, Total Cholesterol)

Cross-matching, gram-staining, and KOH mount (hospital-based)

Under the General Tertiary classification, what services are provided?

Services provided by secondary lab

Special chemistry

Special hematology

Coagulation procedures

Immunology/Serology

Microbiology

What is under the Limited Service Capability?

Provides the lab tests required for a particular service in institution like dialysis centers and social hygiene clinics.

What is offered by the Special Clinical Laboratory?

Molecular and cellular technology

Forensic pathology

Molecular pathology

Assisted reproduction technology

What is a Blood Station?

A government, private hospital or a Philippine National Red Cross chapter which has not been licensed as a blood center but has been authorized by the DOH to store and issue blood and blood products.

What is a Drug Testing Laboratory?

A private or government facility capable of testing a specimen to determine the presence of dangerous drugs.

What are the two classifications of a Drug Testing Laboratory?

Screening

Confirmatory

What is the responsibility of a Reference Laboratory? (National Reference Laboratory)

To assign target values to reference materials, using the best analytical method available.

What does the Research Institute for Tropical Medicine focus on as a National Reference Laboratory?

Dengue, Influenza, Tuberculosis and other Mycobacteria

Malaria and other parasites

Bacterial enteric diseases

Measles and other Viral exanthems

Mycology

Enteroviruses

Antimicrobial resistance and Emerging Diseases

Confirmatory testing of blood units

What does San Lazaro Hospital cover as an NRL?

HIV/AIDS

Hepatitis

Syphilis

Other STIs

What does the National Kidney and Transplant Institute cover as an NRL?

Hematology, including Immunohematology

Immunopathology

Anatomic Pathology

What is a Clinical Research Laboratory?

Labs where tests are performed for research purposes.

Results are usually not related to participants of the research.