Professional Documents
Culture Documents
CPD and Nature of Clinical Laboratory
CPD and Nature of Clinical Laboratory
13, 1995
DEVELOPMENT • PRC Chair
• PRC Resolution No. 381, s. 1995
CPD entitled “Standardized Guidelines and
• A mandatory and the longest phase of Procedures for the Implementation of the
professional education Continuing Professional Education (CPE)
• inculcation of advanced knowledge, skills, Programs for all Professions”
& ethical values in a post-licensure
specialization or in an inter- or Administrative Order No. 260, s. 1996 E.O.
multidisciplinary field of study, for No. 266 - Completion of 60 CPE units as a
assimilation into professional practice, condition for the renewal of licenses
self-directed research and/or lifelong
learning Dec. 5, 2000
• on-going planned, learning & • PRC Modernization Act of 2000 (RA
development process that: 8981)
✓ expands & fulfill full potentials
✓ contribute to work-based & personal 2004
development • Resolution No. 179
✓ can be applied/assessed against • Voluntary CPE program
competences for the workers role
and organizational performance PRC Resolution 2008-466 – moral obligation
• pre-requisite for salary adjustment in to obtain CPE units
developed countries
PRC Resolution 2013-774 – revised CPE/CPD
BENEFITS OF CPD Guidelines to CPD Guidelines
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CPD PROVIDERS FOR MTs (as of Feb. 19, GENERAL MATRIX OF CPD ACTIVITIES
2021 = 118)
1. Formal Learning
2. Non-formal Learning.
3. Informal Learning
4. Self-directed Learning
5. Online Learning Activities
6. Professional Work Experience
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If a professional attended a training/seminar CPD LOGO
that was not organized by a CPD provider or
has no assigned CPD units, he/she can apply
the said training/seminar to the CPD Council.
They will convert those to CUs & he/she will be
entitled to a Certificate of Credit Units
Earned.
3
PRC RESOLUTIONS
CONCEPT PAPER
Purpose
• Illustrate proposed project/plan is worth
doing because it is interesting & has
significance
• methods proposed are feasible and are
likely to work & can be performed within
the specific time period allocated
• explain what the plan/project is all about
Components
• Assessment
• Rationale/introduction
• Objective of training (CPD)
• Methodology
• Date of implementation & duration
• Venue
• Expected output/outcome
• Evaluate
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NATURE OF CLINICAL LABORATORY B. Free Standing – not part of an
established institution
Clinical Laboratory
• where specimens (blood & other body 3. Ownership
fluids, tissues, feces, hair, nails, etc.) A. Government - owned,
collected from individuals are processed, wholly/partially, by national/local
analyzed, preserved & properly disposed government units (usually by DOH)
a. San Lazaro Hospital
• provide accurate & reliable information to
b. Jose R. Reyes Memorial
medical doctors for the diagnosis,
Medical Center
prognosis, treatment, & management of
c. University of the Philippines-
diseases
Philippine General Hospital
• 70% of decision of doctors are based on d. Ospital ng Maynila Medical
lab tests Center
• Involved in research, community outreach e. Sta. Ana Hospital
programs, surveillance, infection control f. Bulacan Medical Center
in hospitals & community settings, B. Privately - owned, established &
information dissemination, & evaluation of operated by an individual,
the applicability of current & innovative corporation, institution, association,
diagnostic technologies or organization
a. St. Luke’s Medical Center
CLASSIFICATIONS OF CLINICAL b. Makati Medical Center
LABORATORIES c. MCU-FDTMF Hospital
1. Function 4. Service Capability
A. Clinical Pathology – testing of A. Primary category – perform basic
blood & other bodily fluids routine lab testing
a. Clinical chemistry a. Routine urinalysis
b. Immunohematology & blood b. Routine stool examination
banking c. Routine hematology or CBC
c. Medical microbiology including hemoglobin (hgb),
d. Immunology & serology hematocrit (HCT), WBC, &
e. Hematology RBC count
f. Parasitology d. WBC differential count &
g. Clinical microscopy qualitative platelet count
h. Toxicology e. Blood typing
i. Therapeutic drug monitoring f. Gram staining (if hospital
j. Endocrinology based)
B. Anatomical Pathology – B. Secondary category (hospital &
microscopic examination of tissues & non-hospital based) – perform lab
organs tests done by the primary category
a. Histopathology with routine clinical chemistry tests
b. Immunohistopathology a. Blood glucose concentration
c. Cytology b. Blood Urea Nitrogen (BUN)
d. Autopsy c. Blood Uric Acid (BUA)
e. Forensic pathology d. Blood creatinine
e. Cholesterol determination
2. Institutional Characteristics f. Qualitative platelet count
A. Institution based/Hospital-based - g. Gram stain (hospital based)
operates within the premises or part h. KOH mount (hospital based
of an institution i. Crossmatching (hospital
a. Hospital based)
b. School C. Tertiary Category (hospital & non-
c. Medical clinic hospital based) – perform all lab
d. Medical facility for overseas tests in secondary category plus:
workers & seafarers a. Immunology & serology
e. Birthing home ➢ NS1-Ag for dengue
f. Psychiatric facility ➢ rapid plasma reagin
g. Drug rehabilitation center
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➢ treponema pallidum Administrative Orders under this RA
particle agglutination A. AO 247, s. 1976 – governing affiliation
tests of MT schools, colleges & universities
b. Microbiology, bacteriology, & in government hospitals under the
mycology DOH
➢ differential staining B. AO 21, s. 1979 – for the accreditation
techniques of training labs for MT interns
➢ culture & identification of C. AO 118-B, s. 1992 – for the
bacteria & fungi from accreditation of clinical labs for training
specimens of MT interns
➢ antimicrobial D. AO 14-A, s. 1997 – revised fees for lab
susceptibility testing diagnostic procedures performed in the
c. Special clinical chemistry BRL
➢ clinical enzymology E. AO 19-A, s. 1998 – the national policy
➢ therapeutic drug on cyto-screening in cervical cancer
monitoring control program designation of MTs as
➢ markers for certain cyto-screeners
diseases F. AO 7-C, s. 2001 – decentralization of
d. Special hematology some regulatory functions of the
➢ bone marrow studies Bureau of Health Facilities and
➢ special staining for Services on Clinical Laboratories & HIV
abnormal cells testing labs to the centers for health
➢ red cell orphology development in the transition phase
e. Immunohematology & blood
banking 2. AO 59, s. 2001
➢ blood donation program • Nov. 19, 2001
➢ antibody screening &
identification A. Section 1: Title
➢ preparation of blood • “Rules and Regulation
components Governing the Establishment,
D. National Reference Laboratory - Operation, and Maintenance of
lab in a government hospital Clinical Laboratories in the
designated by the DOH to provide Philippines”
special diagnostic functions & B. Section 2: Authority
services for certain diseases • Implements RA 4688
a. Referral services • DOH, through the Bureau of
b. Provision of confirmatory Health Facilities and Services
testing (BHFS) shall exercise the
c. Assistance for research regulatory functions under
activities these rules & regulations
d. Implementation of External C. Section 3: Purpose
Quality Assurance Program • To protect & promote health of
(EQAP) of government the people by ensuring
e. Training of MTs on certain availability of clinical labs that
specialized procedures that are properly managed with
require standardization adequate resources, with
effective & efficient
CLINICAL LABORATORY LAWS performance through
compliance with quality
1. RA 4688 standards
• June 18, 1966 D. Section 4: Scope
• “Clinical Laboratory Laws” • Apply to all entities performing
• regulating the operation & the activities & functions of
maintenance of clinical labs & clinical labs (analysis &
requiring the registration of the same examination of all samples of
with the DOH, providing penalty for the human tissues & body fluids)
violation thereof, & for other purposes • except for government labs
• preventing the operation & of doing lab examinations limited
substandard improperly managed & to acid fast bacilli microscopy,
poorly equipped labs
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malaria screening & cervical L. Section 12: Publication of List of
cancer screening Licensed Clinical Labs
E. Section 5: Classification of Labs • A list of licensed clinical labs
F. Section 6: Policies must be published annually in a
• Permit to construct is given by newspaper or general
BHFS prior to submission of circulation.
Petition to Operate M. Section 13: Effectivity
• license to operate is issued by • Rules & regulations shall take
BHFS/CHD effect 15 days after its
G. Section 7: Requirements & publication in a newspaper or
Procedures for Application of Permit general circulation.
to Construct & License to Operate
• Inspection shall be done by TECHNICAL STANDARDS & MINIMUM
director of BHFS/CHD every REQUIREMENTS
two years or as necessary
H. Section 8: Violations 1. Staffing – should have continuing
• Operation of a clinical lab education program, available to upgrade
without a certified pathologist or knowledge & skills
registered MT A. Managed by licensed pathologist
• change of ownership, location, • Otherwise, a physician with 3
head of laboratory or personnel months training on clinical
without informing the laboratory medicine, quality
BHFS/CHD control & lab management
• refusal to allow inspection of the B. Enough RMTs – at least 1 RMT per
clinical lab by the person/s shift (hospital-based)
authorized by the BHFS during
reasonable hours 2. Physical Facilities
• gross negligence • Well-ventilated, adequately lighted,
• any act/omission detrimental to clean & safe
the public • With adequate water supply &
I. Section 9: Investigation of sufficient space
Charges/Complaints
• Done by BHFS/CHD
• violation of RA 4688 will mean
suspension, cancelation or
revocation of the license as well
as the authority of the offending
person/s
• operation without proper license
shall be subjected to 3. Equipment/Instruments
imprisonment for 1 month - 1
year, or fine of P1000.00 -
P5000.00, or both
J. Section 10: Modification &
Revocation of License
• A license may be revoked,
suspended or modified in full or
in part for any material false
statement by the applicant, or
as shown by the record of
inspection or for a violation of,
or failure to comply any of the
terms and conditions &
provisions of these rules &
regulations.
K. Section 11: Repealing Clause 4. Quality Control Program
• Rules & regulations shall A. Internal QC
supersede all other previous
• Shall provide quality control
official issuance hereof. reference materials
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• Shall be documented, • Special tests
continuous competency ➢ TFT (T3, T4, TSH)
assessment program for all ➢ Estrogen
laboratory personnel ➢ Prolactin
• Shall provide standard lab ➢ Testosterone
methods, reagents, supplies & ➢ TDM (for prohibited drugs)
equipment • Blood & urine – most common to be
B. External QC tested
• Given by national reference • One of the busiest sections
laboratory • State-of-the-art, fully automated
• All clinical labs shall participate
for it is one of the criteria for 2. Microbiology
renewal of license. Any refusal • Identifies bacteria & fungi on specimen
shall mean suspension of • 4 sections
license. ➢ Bacteriology
5. Reporting ➢ Mycobacteriology
• Results shall be signed by both RMTs ➢ Mycology
& the pathologist ➢ Virology
• Lab requests shall be construed as a • Examples
consultation between the physician & ➢ microscopic visualization of
the pathologist microorganisms after staining
• Shall not issue a report orally or in ➢ isolation & identification of
writing without a directive from the bacteria (aerobes & anaerobes) &
pathologist fungi using varied culture media &
different biochemical tests
6. Recording ➢ antigen typing
• To ensure quality results ➢ antibacterial susceptibility
➢ preparation of culture media &
7. Laboratory Fees stains
• Lab and professional fees to be ➢ infection control
charged for lab examination shall be at • blood & other body fluids, stool,
prevailing rates tissues & swabs are usually tested
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Preparation of blood smear for differential 4. Clinical Microscopy
count A. Urinalysis
• Macroscopic examination
(color, transparency, specific
gravity, & pH level)
• microscopic examination
(detect presence of abnormal
cells and/or parasites as well as
quantify red cells & WBC)
• chemicals examination
B. Fecalysis
• Detection & identification of
parasitic worms & ova
5. Blood Bank/Immunohematology
• Most critical section
• Blood typing & compatibility testing
(two main activities)
• Antibody screening & identification
• Donor recruitment & screening,
bleeding of donor & post-donation
care (hospital-based clinical lab)
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LABORATORY TESTING CYCLE &
QUALITY ASSURANCE
3. Post-analytic Phase
• Transmission of test results to the MD
for interpretation
• Turn around time (TAT)
• Application of doctor’s
recommendations
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• Wrong values used
QUALITY ASSURANCE
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