LECTURE 4 - RA 4688 The Clinical Laboratory Law of 1966 (Part 1)

RA NO. 4688

It is the law regulating the operation and maintenance of clinical laboratories and requiring the registration of the same with the DOH through the HSFRB

• GOVERNMENT OWNED

• PRIVATE

BASED ON OWNERSHIP:

GOVERNMENT OWNED

These are the laboratories which are maintained either partially or wholly by either the national or local government.

(BASED ON OWNERSHIP)

PRIVATE

They are established or operated by an individual or by a corporation or association without any affinity with the government.

(BASED ON OWNERSHIP)

• Clinical Pathology Function

• Anatomic Pathology Function

BASED ON FUNCTION:

CLINICAL PATHOLOGY FUNCTION

The laboratory that provides tests involving clinical chemistry, hematology, immunohematology or blood banking, microbiology, immunology, clinical microscopy, serology, endocrinology, molecular biology, cytogenetics, toxicology, and therapeutic drug monitoring.

(BASED ON FUNCTION)

ANATOMIC PATHOLOGY FUNCTION

Provides diagnosis through surgical, immunology, histopathologic, cytologic, autopsy procedure, forensic, and molecular pathologic techniques.

(BASED ON FUNCTION)

• Institution-Based Clinical Laboratory

• Free Standing

BASED ON INSTITUTIONAL CHARACTER:

INSTITUTION-BASED CLINICAL LABORATORY

Operates within the premises and as part of an institution such as a hospital, clinic, school, or a medical facility.

(BASED ON INSTITUTIONAL CHARACTER)

FREE STANDING

Has no affinity with any other institution.

(BASED ON INSTITUTIONAL CHARACTER)

• PRIMARY

• SECONDARY

• TERTIARY

• LIMITED SERVICE

BASED ON SERVICE CAPACITY “GENERAL”:

PRIMARY

Offer standard laboratory procedures such as routine hematology, urinalysis, fecalysis, and blood typing.

SECONDARY

Primary lab services + routine chemistry analysis, cross-matching, Gram staining, and KOH preparations

TERTIARY

Primary & Secondary lab services + special chemistry procedures, special hematology (coagulation procedures, immunology & culture, and sensitivity procedures)

LIMITED SERVICE

For institution based only, they provide laboratory tests required for a particular service in institutions such as they are not limited to dialysis centers and even social hygiene clinics.

(BASED ON SERVICE CAPACITY “GENERAL”)

PRIMARY

Routine Hematology

(PRIMARY / SECONDARY / TERTIARY / LIMITED SERVICE)

PRIMARY

Urinalysis

(PRIMARY / SECONDARY / TERTIARY / LIMITED SERVICE)

PRIMARY

Fecalysis

(PRIMARY / SECONDARY / TERTIARY / LIMITED SERVICE)

PRIMARY

Blood Typing

(PRIMARY / SECONDARY / TERTIARY / LIMITED SERVICE)

SECONDARY

Primary lab services

(PRIMARY / SECONDARY / TERTIARY / LIMITED SERVICE)

SECONDARY

routine chemistry analysis

(PRIMARY / SECONDARY / TERTIARY / LIMITED SERVICE)

SECONDARY

cross-matching

(PRIMARY / SECONDARY / TERTIARY / LIMITED SERVICE)

SECONDARY

Gram staining

(PRIMARY / SECONDARY / TERTIARY / LIMITED SERVICE)

SECONDARY

KOH preparations

(PRIMARY / SECONDARY / TERTIARY / LIMITED SERVICE)

TERTIARY

Primary & Secondary lab services

(PRIMARY / SECONDARY / TERTIARY / LIMITED SERVICE)

TERTIARY

special chemistry procedures

(PRIMARY / SECONDARY / TERTIARY / LIMITED SERVICE)

TERTIARY

special hematology

(PRIMARY / SECONDARY / TERTIARY / LIMITED SERVICE)

TERTIARY

coagulation procedures

(PRIMARY / SECONDARY / TERTIARY / LIMITED SERVICE)

TERTIARY

immunology & culture

(PRIMARY / SECONDARY / TERTIARY / LIMITED SERVICE)

TERTIARY

sensitivity procedures

(PRIMARY / SECONDARY / TERTIARY / LIMITED SERVICE)

148; 2003

Under the department memorandum number ___ series of ____, a primary clinical laboratory must have minimum technical working area of at least 10 square meters

10

Under the department memorandum number 148 series of 2003, a primary clinical laboratory must have minimum technical working area of at least ___ square meters

20

For secondary clinical laboratory, they require minimum technical working area of at least ___ square meters.

60

For a tertiary clinical laboratory, it must have a minimum technical working area of at least ___ square meters.