ANSWERSHEET IN LABORATORY MANAGEMENT ACTIVITIES
Activity 1: How will I classify a clinical laboratory?
In reference to RA 4688 and DOH Administrative Order No. 59 s. 2001 clinical laboratories classified
accordingly:
1. Classification by function
a. Clinical pathology is a clinical
laboratory that specializes in the
diagnosis and treatment of
illnesses utilizing laboratory
analysis of fluid and electrolyte
balance.
b. atomic pathology
2. Classification by Institutional Character
3. Classification by Service Capability
a. Primary – provides the minimum service capabilities such as:
Examinations conducted
Sections to be established in the laboratory
Clinical chemistry, immunohematology and blood
banking, medical microbiology, immunoserology,
hematology, parasitology, clinical microscopy,
toxicology, therapeutic drug monitoring, and
endocrinology are only a few examples.
Surgical Pathology, Immunohistopathology, Cytology,
Autopsy and Forensic Pathology.
a. Hospital–based laboratory – a laboratory that
operates within a hospital.
b. Non–hospital–based laboratory – a laboratory that
operates on its own.
(1)Routine Hematology (Complete Blood Count or
CBC)
– includes Hemoglobin Mass Concentration,
Erythrocyte Volume Fraction (Hematocrit),
Leukocyte Number Concentration (WBC count)
and
Leukocyte Type Number Fraction (Differential
Count), Qualitative Platelet Determination
(2)Routine Urinalysis
(3)Routine Fecalysis
(4)Blood typing – hospital based
(5)Quantitative platelet determination – hospital
based
b. Secondary – provides the minimum service capabilities of a primary category and the following:

(1) Routine Clinical Chemistry – includes Blood

Examinations conducted
Glucose
Substance Concentration, Blood Urea Nitrogen
Concentration, Blood Uric Acid Substance
Concentration, Blood Creatinine Concentration, Blood
Total Cholesterol Concentration
(2) Cross matching
c. Tertiary – provides the secondary service capabilities and the following:

Examinations conducted (1) Special Chemistry- Clinical enzymology,

therapeutic medication monitoring, and markers
for specific disorders
(2)
(3) Special Hematology- Studies on bone marrow,
specific labeling for abnormal cells, and red cell
morphology
(4)
(5) Immunology/Serology- NS1-Ag for dengue, fast
plasmaregin, and particle agglutination tests for
Treponema pallidum
(6)
(7) Microbiology- Differential staining methods,
culture and identification of bacteria and fungus
from specimens,  testing for antimicrobial
susceptibility

Activity 2: How to start a clinical laboratory?

From the perspective of laboratory operation in relation to administrative-order-no-59-s-

2001, policies are created governing the operation and management of the clinical
laboratory such as the following:

1. it has an approved permit to construct and design lay–out of a clinical laboratory shall be secured
form the BHFS prior to submission of an application for a Petition to Operate;
 Activity 2.a: Insert a sample layout of a clinical laboratory and building permit. (Visit a web
for a sample layout /permit or if you have known someone has building layout or a permit
then takes a photo on it. Just cover the identity of the owner). Discuss in short detail the
content of the lay-out and of the permit. Use a separate sheet for your output for WM and
PM students, whereas for OM students attached all your output to GCR link

Designing a laboratory is a highly involved is a higly involved and complex process. The following are
the policies for clinical laboratory permit which includes, An approved permit to construct and design
lay–out of a clinical laboratory shall be secured form the BHFS prior to submission of an application for
a Petition to Operate. No clinical laboratory shall be constructed unless plans have been approved and
construction permit issued by the BHFS. A clinical laboratory shall operate with a valid license issued by
BHFS/CHD, based on compliance with the minimum licensing requirements (Annex A). The clinical
laboratory shall be organized and managed to provide effective and efficient laboratory services. The
clinical laboratory shall provide adequate and appropriate safety practices for its personnel and
clientele.

2. must have been approved and construction permit issued by the BHFS;

Activity 2.b Insert a sample an approved construction permit issued by the BHFS. (Visit a web
for a sample form / if you have known someone approved construction permit then take a
photo on it. Just cover the identity of the owner). Discuss in short detail the content of
sample form. Use a separate sheet for your output for WM and PM students, whereas for
OM students attached all your output to GCR link

The license shall be issued by the

Director of the CHD or his
authorized representative, if the
application is found to be
meritorious. Clinical laboratories
 3. shall operate with a valid license issued by BHFS/CHD, based on compliance with the minimum
licensing requirements

Activity 2.c Insert a sample an approved LTO by the BHFS. (Visit a web for a sample form / if
you have known someone approved construction permit then take a photo on it. Just cover
the identity of the owner). Discuss in short detail the content of sample form. Use a separate
sheet for your output for
WM and PM students, whereas for OM students attached all your output to GCR link

The LTO shall be issued only to clinical

laboratories that comply with the standards and
technical requirements formulated by the BHFS.
The LTO of a clinical laboratory shall be
automatically cancelled without notice when it
fails to submit a duly accomplished application
form and to pay the proper fee on or before the
4. The clinical laboratory shall be expiration date stated in its license.
organized and managed to provide
effective and efficient laboratory services;

Activity 2.d Insert a sample an organization structure of your proposed clinical laboratory. You
can use fictitious name to simulate an organization with their corresponding position and
function (Visit a web for a sample form / if you have known a laboratory with established
organization structure take not of it for your output presentation. Observe Data privacy.
Discuss in short detail the significance of the organization structure. Use a separate sheet for
your output for WM and PM students, whereas for OM students attached all your output to
GCR link

The Organizational Chart: Establishes core authority and responsibility. Clarifies different
authorities and responsibilities for the Laboratory Director, the Pathologists, the Laboratory
Manager and the Technical Supervisors (CLIA requirements) Identifies hierarchies and
relationships.

5. The clinical laboratory shall provide adequate and appropriate safety practices for its personnel
and clientele