LECTURE 4 - RA 4688 The Clinical Laboratory Law of 1966 (Part 2)

BIOSAFETY LEVEL 1

Handle organisms which are considered by the WHO as Risk Group 1

(BIOSAFETY LEVEL)

BIOSAFETY LEVEL 1

Personnel are expected to wear standard PPE (masks, gloves, and laboratory gowns) and supervised by a scientist with training in microbiology or related field

(BIOSAFETY LEVEL)

BIOSAFETY LEVEL 1

Special containment systems NOT required

(BIOSAFETY LEVEL)

BIOSAFETY LEVEL 2

Handle a broad spectrum of moderate risk agents

(BIOSAFETY LEVEL)

BIOSAFETY LEVEL 2

Personnel process human-derived specimens (blood, body fluids, tissues, and human cell lines with unknown disease-causing organism)

(BIOSAFETY LEVEL)

BIOSAFETY LEVEL 2

PPE + Secondary barriers (sink, waste decontamination facilities to reduce transmission of biohazard waste, and biosafety cabinet)

(BIOSAFETY LEVEL)

BIOSAFETY LEVEL 3

Handle indigenous or exotic agents that can be transmitted via respiratory routes and cause severe or sometimes fatal infections

(BIOSAFETY LEVEL)

BIOSAFETY LEVEL 3

Access to laboratory is controlled to prevent infectious aerosols from escaping to the environment.

(BIOSAFETY LEVEL)

BIOSAFETY LEVEL 3

ALL procedures should be done in biosafety cabinets with gas-tight aerosol generation chamber

(BIOSAFETY LEVEL)

BIOSAFETY LEVEL 4

Handle extremely dangerous and exotic agents that can be transmitted through the air, have NO available vaccine or therapeutic cure

(BIOSAFETY LEVEL)

BIOSAFETY LEVEL 4

Personnel are required to wear full body, air-supplied positive-pressure suits

(BIOSAFETY LEVEL)

BIOSAFETY LEVEL 4

Provided with a specialized ventilation and waste management system

(BIOSAFETY LEVEL)

BIOSAFETY LEVEL 4

Operates in a separate building

(BIOSAFETY LEVEL)

LICENSE

Is a document issued by the DOH to an individual , agency, partnership, or a corporation that operates a clinical laboratory upon compliance with the requirements set forth by the law.

License to Operate

LTO

annually; HFSRB

As a general rule, any person or any firm or any corporation operating and maintaining a Clinical Laboratory, they are required to register and secure a license ____ with the ____.

Health Facilities and Services Regulatory Bureau

HFSRB

National Reference Laboratory

NRL

valid for 1 year and must be renewed annually

HOW LONG IS THE VALIDITY OF THE LTO?

PHYSICIAN’S OFFICE LABORATORY (POL)

Is an individual doctors' office/ clinic wherein laboratory examinations are performed, Examinations done in a POL are be permitted as long as they are used

MOBILE CLINICAL LABORATORY

Is a specialized facility that moves from one testing site to another or has a temporary testing location. It shall have a base laboratory

specimens

Mobile clinical laboratories are licensed as part of the main clinical laboratory and they are only permitted to collect ___ only.

100 kilometer

Mobile clinical laboratory is only allowed to operate within _____ radius from its main laboratory only

RCPCL

Clinical laboratories conducting a mobile collection they are required to secure an ____ from DOH

Remote Collection Permit for Clinical Laboratory

RCPCL

two weeks

The RCPCL is only valid for ______ from the date of issuance

POINT OF CARE TESTING (POCT)

Is a diagnostic test at or near the site of patient care rather than in the clinical laboratory. It includes bedside testing, outpatient services and home care.

POINT OF CARE TESTING (POCT)

This may be used for screening patients, preliminary diagnostic testing for emergency treatment and monitoring of status of patients under treatments such as blood glucose level for diabetics.

• Clinical Pathologist

• Anatomic Pathologist

WHO HEADS AND MANAGES A CLINICAL LABORATORY?

HFSRB or Center for Health Development (CHD)

WHERE IS THE APPLICATION FOR LTO FILED?

Center for Health Development

CHD

HFSRB and CHD

WHO INSPECTS AND MONITORS CLINICAL LABORATORIES?

NATIONAL REFERENCE LABORATORY (NRL)

Is a laboratory in government hospital which has been designated by the DOH to provide special functions and services for specific disease areas.

NATIONAL REFERENCE LABORATORY (NRL)

They may or may not be part of a general clinical laboratory.