The Clinical Laboratory

and Its Laws

Prepared by: @filconicles, MSMT, RMT
Objectives:

1. Classify the clinical laboratories in the Philippines

2.Examine the provisions of laws governing the
clinical laboratories in the Philippines
3. Analyze the legal issues and concerns of clinical
laboratories
4, Explain the various aspects of managing, teaching,
and training in clinical laboratories
#Throwback

As defined by RA 5527,a medical technologist is a

person who works in a laboratory where he/she 1s
expected to practice his/her laboratory skills with high
accuracy and competency.
However, a clinical laboratory alone is difficult to
maintain and proprietors of such a place need to
consider a number of things for it to continue
operations.
This lecture deals with the classification of clinical
laboratoriesin the Philippines and the laws governing
them.
Classification of Clinical
Laboratories in the
Philippines
 Based on Ownership
GOVERNMENT-OWNED or PRIVATE

CLINICAL LABORATORY |
MR. JOSEPH
M.SC. MLT (PATH) POIMECHANDIGARH TECH. '
EX. PGIMED. TECHNOLOGIST / TUTOR
M: 98720-38961, 98728-03375
BT Aa oe ae

* Maintained partially or wholly * Established, operated, and

by either the national or local maintained by an individual,
government corporation, or association
without any affinity with the
government.
 Based on Function
CLINICAL PATHOLOGY or ANATOMIC
PATHOLOGY
|
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* Provides diagnosis through tests * Provides diagnosis through
involving clinical chemistry, surgical, immunology,
hematology, immunohematology, histopathologic, cytologic,
microbiology, immunology, autopsy procedure, forensic,
Clinical microscopy, serology, and molecular pathologic
endocrinology, molecular techniques.
biology, cytogenetics, toxicology,
and therapeutic drug monitoring.
Based on Institutional Character
INSTITUTION-BASED or FREE-STANDING

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* Operates within the premises ° Has no affinity with any other

and as part of an institution institution
such as a hospital, clinic, school,
or a medical facility

* Example: National Kidney and + Example: Hi-Precision Diagnostics

Transplant Institute
Based on Service Capacity
* Offer standard laboratory procedures
such as routine haematology,
urinalysis, fecalysis, and blood
typing
* Primary lab services + _ routine
chemistry analysis, cross-matching,
Gram staining, and KOH
preparations

* Primary & Secondary lab services +

special chemistry procedures,
special hematology (coagulation
procedures, immunology & culture,
and sensitivity procedures)
 WHO Organization of
Laboratories Based on
Biosafety Level
 RISK
GROUP Agent Risk Description Examples
(RG)
Bacillus subtilis
Agents that are NOT associated with diseases in healthy Escherichia coli K12
adult humans Adeno-associated
virus (AAV)

Staphylococcus
aureus
Agents that are associated with human diseases that are
Salmonella sp
RARELY serious and for which preventative or therapeutic
Herpes simplex
interventions are OFTEN available viruses
Adenovirus

Agents that are associated with SERIOUS or LETHAL — Mycobacterium tuberculosis

human diseases for which preventative or therapeutic Bacillus anthracis
interventions MAY BE available HIV
|

Agents that are likely to cause SERIOUS or LETHAL Ebola virus

human diseases for which preventative or therapeutic Marburg virus
interventions ARE NOT USUALLY available Lassa virus
 Biosaiety Lé
* Handle organisms which are
considered by the WHO as
Risk Group1

* Personnel are expected to

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

* Special containment systems

NOT required
 Biosaiety Level 2 a.

* Handle a broad spectrum of

moderate-risk agents or Risk
Group 2 organisms oe

* Personnel process human- \ ,

derived specimens (blood,
body fluids, tissues, and human BioSatety
cell lines with unknown disease- ?
LEVEL Gy
causing organism)
* PPE + Secondary barriers Aa
(sink, waste decontamination \ y)
facilities to reduce transmission KE
of biohazard waste, and InFeohoge LEVEL 2
biosafety cabinet) atteY ae a
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engBITE NG
 Biosatety Level 3
* Handle indigenous or exotic
agents that can be transmitted
via respiratory routes and
Cause severe or sometimes fatal : ‘
infections (Risk Group 3
organisms) = * ¥

* ALL procedures should be done Pn ey ae IV

in biosafety cabinets with gas- -_. — / os
tight aerosol generation
chamber

* Access to laboratory is an
controlled to prevent infectious ]
aerosols from escaping to the [ LEVE, oe
environment —
 Biosaieiy Level 4
* Handle extremely dangerous
and exotic agents that can be
transmitted through the air,
have NO available vaccine or
therapeutic cure (Risk Group 4)

* Personnel are required to wear

full-body, air supplied
positive-pressure suits

* Provided with a specialized

ventilation and waste
management system

* Operates in a_ separate
building
Pertinent Laws
Administrative Order No. 2007-0027 (Clinical
Laboratory Staff)
° A clinical laboratory should be headed by a registered
medical technologist and managed by a pathologist who
is duly certified by the Philippine Board of Pathology.

Republic Act No. 4688 (Clinical Laboratory Act of

1966)
* Approved: June 18, 1966

* To regulate the operation and maintenance of Clinical

laboratories and to require their registration with the DOH,
providing penalty for the violation thereof and other purpose
Legal Issues and
Concerns
Increasing number of clinical laboratories
categorised as secondary or tertiary specially in
poor communities deserving healthcare attention.
* Almost all clinical laboratories are located in NCR and a
small number are situated in provinces

* People prefer to have their laboratory examinations done

outside their province - they believe more reliable results
can be obtained
Increasing number of registered medical
technologists per clinical laboratory especially
the replacement of senior and retiring ones.
* Need for MTs has been observed due to high number of
retiring medical technologists

* Problem lies on the need not only for more MTs but also
for the experience and training of newly hired MTs
Accreditation and ISO certification of
Clinical laboratories pursuant to the
Modernization Act of 2011
Requirement for clinical laboratories especially those
which are intended for the training of MT interns to
achieve accreditation levels including other requirements
imposed by the accrediting agency

Problem pertains to the expenses incurred for

accreditation (e.g. ISO certification)
Close monitoring of clinical laboratories
that usually operate as single
proprietorship, especially in remote areas
* Clinical laboratories charge high laboratory fees if tests
require special procedures

* Small laboratories provide routine urinalysis, fecalysis,

and complete blood counts - still classified as primary
laboratories
Salary and compensation
offered by clinical laboratories
* Compensation and salary in government laboratories
depend on rank and item appropriated in the budget

* Private laboratories - MTs receive a commission for the

service which they rendered per hour or for test
performed
High turnover rate of clinical
laboratory staff
* Another reason for the increasing demand for medical
technologists

* Problem is the hiring of experienced and well-trained MTs

Expensive sophisticated
automation in the laboratory
* Tertiary category laboratories - require sophisticated or
automated instrumentation

* Rationale - to provide immediate laboratory test results

and automation entails costs
Confidentiality of results
* Right of the patient to have exclusive ownership of
information on the results of his/her lab tests

* In some cases, the laboratory cannot refuse the results to

the relatives of the patients
Training of clinical
laboratory staff
* Another requirement for most clinical laboratories

* Training of staff - discretionary depending on the rank

priority of the hospital

* Some hospitals offer rigid in-house training of their MT

Continuing professional
education
* Required for renewal of license

* School based laboratories - continuing professional

education is needed for promotion

* Issue: whether all members of the laboratory staff have

the chance to obtain a continuing professional education