Module 2:

AO No. 0027 s. 2007

Republic Act 688

1. Rationale- The registration, operation and
maintenance of Clin. Lab. In the Phils.

Introduction -Preventing substandard, Improperly managed and

 Basic License Requirements
o “Petition to Establish, Operate and
Maintain a Clinical Laboratory”
 Inspection of Laboratory
o w/in 60 days after filling of
application
 Expiration of License
o Every last day of December of the
year
 Renewal of License
o Every last 2 months of the year
BUREAU OF RESEARCH
poorly equipped clinical laboratories
2. Objective- Promulgated to prescribe a revised
minimum standard for clinical laboratories
III. Scope & Coverage
 Applies to all entities performing the
activities and functions of clinical labs
 Excludes government laboratories doing
laboratory examinations limited to  AFB
microscopy,  malaria screening and cervical
cancer screening; declared as extension of a
licensed government clinical lab

AND LABORATORY 1. Definition of Terms

 DOH (through the BRL)  Applicant 

o The central governmental agency  BHFS 
authorized to regulate the operation and  CHD 
maintenance of lab  Clinical Laboratory
 The secretary of DOH through the director  Critical values 
of BRL  DOH 
o Formulate rules and regulations  EQAP
 Inspection Tool
 AO 201 s. 1973- The 1st implementing rules and  License 
regulation  Licensee 
 AO 201 s. 1973  LTO 
 AO 290 s. 1976  Mobile Clinical Laboratory
 AO 52 s. 1983  Monitoring Examinations 
 AO 49-B s. 1988  Institution 
 EO 102 s. 1999  NRL

o Redirecting the Functions &  Confirmatory testing;

Operations of the DOH  Surveillance;
o AO 59 s. 2001  Resolution of conflicting
results;
o Rules & Regulations Governing The
 Training and research;
Establishment, Operation & Maintenance
 Evaluation of diagnostic
of Clinical Laboratories in the Philippines
kits and reagents
o AO 27 s. 2007
o Revised Rules & Regulations
Governing the Licensure and Regulation of National Reference
Clinical Laboratories in the Philippines
Laboratory

Arellano,Abigail U.
BSMT-2C
 RITM Research Institute for Tropical o Includes all medico-legal
Medicine examinations
o Dengue, Influenza, TB and Malaria
o NRL for confirmatory testing of  Classification by Service Capability
blood units.
 SLH San Lazaro Hospital General Clinical Laboratory
o HIV/AIDS, Hepatitis, Syphilis and
other Sexually Transmitted Infections (STls).  PRIMARY
 East Avenue Medical Center
o Toxicology and Micronutrient
 Routine hematology (CBC) – Hb, Hct,
Assay WBC & Differential count
 NKTI National Kidney and Transplant  Qualitative platelet determination
Institute  Routine urinalysis
o Hematology / Immunohematology  Routine fecalysis
 Lung Center of the Philippines  Blood typing

 Biochemistry
 POL – Physician Office Laboratory
 POCT – Point of Care Testing (at or near the
 SECONDARY – primary lab services +
site of the patient)
 Routine Test – basic, commonly requested
 Routine clinical chemistry – includes
tests
blood glucose, BUN, BUA, Crea & total
 Satellite Testing Site – any testing site that
cholesterol
performs lab exams outside the physical
 Quantitative platelet determination
confines of the base lab
 Cross matching
 STAT Tests – urgent tests and to be
 Gram staining
released within one hour after procedure
 KOH

Classification of  TERTIARY – secondary lab services +

Laboratories
 Special chemistry
 Classification by Ownership  Special hematology
o Government  Immunology/serology
o Private  Microbiology (C/S)
 Classification by Function
o Clinical Pathology  LIMITED SERVICE CAPABILITY (for
o Anatomic Pathology institution based only) – i.e. dialysis
o centers & social hygiene clinics
 Classification by Institutional Character
o Institution-based o Note: Labs can be permitted to
o Freestanding offer other lab services provided they
comply with reqt’s with respect to, staff,
 Clinical Pathology equipment, reagents and supplies and
o Includes CC, Hema, Micro-Para, listed under its LTO
Mycology, CM, etc.  SPECIAL CLINICAL LABORATORY
 Anatomic Pathology – offers highly specialized laboratory
o Includes surgical pathology, services that are usually not provided
histochemistry, immunopathology, by a general clinical laboratory
cytology and post-mortem examinations
 Forensic Pathology  Assisted Reproduction Technology
Labs

Arellano,Abigail U.
BSMT-2C
  Molecular and Cellular Technology
 Molecular Biology
 Molecular Pathology
 Forensic Pathology
 Anatomic Pathology
1. Guidelines
 General Guidelines
 The LTO shall be issued only to clinical labs
that comply with standards and technical
requirements formulated by the BHFS
 Clinical labs operated and maintained for
research and teaching
purposes – exempted but needs to be
registered with BHFS
 Special clinical labs are required to register
with BHFS without being licensed (if not
subject to other AO)
 NRL- designated by DOH shall be covered
by license of the clinical lab of the hospital
 Register only with BHFS if
physically independent & duly
accredited by international certifying
body
 CDC, WHO,
 POL – required of license if doing any or all
of the ff:
 Issue official lab results
 Perform more than monitoring exams
 Cater not only to physician’s own
patients
 Specific Guidelines
o Standards
 Human Resources
 Equipment
 Glassware, Reagents & Supplies
 Administrative Policies & Procedures
 Technical Procedures
 Quality Assurance Program
 Communication & Records
 Physical facilities/ Work Environment
 Referral of Examinations Outside of
the Clinical Lab
o LTO
 Issued in the name of licensee and is
non-transferrable
 Valid for 1 year
 Expires on the date set forth by CHD
 Capability to perform HIV testing and
or drinking H2O analysis shall be
specifically indicated in the LTO
 MOBILE LABS permitted to collect
specimens only & operate w/n 100
kms radius from base lab
 Any substantial changes shall be
reported to CHD w/n 2 weeks in
writing
VII. Procedural Guidelines
 Registration for Special Clinical Labs, NRL,
Research & teaching Labs
 Procedures for Application for Initial/Renewal of
LTO
 Renewal of LTO
o Hospital-based – processed under
the One-Stop-Shop Licensure System  for
Hospitals
o Non-hospital based
– beginning 1st day of October until end of
November of current year
o Automatic cancellation of LTO
 Failure to submit duly
accomplished form
 Non-Payment of proper
fee on or before expiration date
o Inspection
 CHD shall conduct
announced inspections at reasonable
time using inspection tool
o Monitoring
 BHFS/CHD Director or rep
shall monitor clinical labs
 Notice of violation for
non-compliant labs shall be issued
immediately
Arellano,Abigail U.
BSMT-2C
  CHD concerned shall
submit quarterly summary of
violations to BHFS
 Provincial, City &
Municipal Health Officers can report
existence of unlicensed labs
VIII. Fees
1. Violations
 Refusal on any clinical lab to participate in
EQAP
 Issuance of a report, orally or in writing
which is not in accordance w/ documented
procedures
 Permitting unauthorized persons to
perform technical procedures
 Incompetence
 Deviations from standard test procedures
 Lending or using the name of licensed lab or
head or RMT to an unlicensed lab
 Unauthorized use of the name and signature of
Pathologist and RMT to secure LTO
 Reporting a test result for clinical specimens
even if the test was not actually done
 Transferring results of tests done in an outside
lab to the result form of the referring lab
 Performing and reporting tests in a specialty or
subspecialty in which the lab is not licensed
 Giving and receiving any commission, bonus or
kickback or rebate or engaging in any split-free
for referral to clinical labs licensed by DOH
1. Investigation of Charges or Complaints
 BHFS/CHD Dir or rep shall investigate the
complaint
 BHFS/CHD Dir or rep shall suspend, cancel or
revoke & may seek any law enforcement
agency to execute the closure of any erring lab
when necessary
 If a corporation- managing head or owner is
liable
XII. Appeal
 Office of the Health Sec w/n 10 days after
receipt of notice of decision
 Decision is final & executory
 Repealing Clause
XIV. Separability Clause
1. Effectivity
Technical Standards and Minimum Requirements
 Staffing
 Managed by licensed Physician certified by
the Philippine Board of Pathology
“Any clinical laboratory weather attached or
unattached to a hospital or clinic performing not
more than 800 examinations a month should have
atleast one medical technologist
For every other additional 800 or fraction thereof,
another medical technologist should be hired”                                            
 RMTs – available at all times during
operation hours
o Hospital-based lab – at least 1
RMT/shift
 Staff development & CPE program
instituted
 Physical Facilities
o Well-ventilated, adequately
lighted, clean & safe
o Work space reqt’s (at least)
 1º - 10 m2
 2º - 20 m2
 3º - 60 m2

1. Penalty Primary Secondary Tertiary

 Clinical All those in 1º All those in 2º
 Imprisonment of not < 1 month; or centrifuge plus the ff: plus the ff:
 Fine not < PhP 1,000 but no > PhP 5,000; or  Hemacytomet  Refrigerator
 er  Photometer
Both  Incubator
 Microhematoc Waterbath
rit centrifuge  Timer  Balance
 Microscope  Rotator
with OIL  Serofuge
Arellano,Abigail U.
 Hemoglobino BSMT-2C  Autoclave
meter  Drying oven
 Differential  Biosafety cabinet
counter
 Equipment/ Instruments

 Glasswares/Reagents/Supplies
 Waste Management
 Laboratory Rates
o Usual rates should take into
consideration costs of production and QC
of various laboratory procedures.
o Service shall be treated separately
and not included in the laboratory rate.

Color Coding Scheme for

Containers

 Quality Control Program

o Internal QC
o External QC
 All labs shall participate in
an EQAS given by designated NRL
 Satisfactory performance
rating – criteria for renewal of license
 Refusal to participate in
EQAS-NRL – basis for
suspension/revocation of license
o Reporting
 Bear the name &
signature of Pathologist & RMT
 No report orally or in
writing without directive from
pathologist or associate except in
emergency cases
o Recording
 All requests and reports of
all specimens submitted and examined
 Kept in file for at least 1
year
 Anatomic and
forensic pathology reports are
kept permanent

Arellano,Abigail U.
BSMT-2C

MODULE 3: PD 223-
Creating the
Professional Regulation
Commission and
Prescribing Its Power
and Functions
PRC: Professional Regulation Commission
 Komisyon sa Pamamalakad ng mga
Propesyonal
 Office of the Boards of Examiners (Old
name)
o RA 546 – was created by RA 546
o CSC – under Civil Service
Commission
 PD 223 – June 22, 1973
 PRC was 1st created as a National
Government Agency by PD 223; Signed by P.
Marcos
o Architech Eric C. Nubla (The first
PRC Commissioner)
R.A 8981 :PRC Modernization ACT of 2000
 Test results were released and published
within an average of three (3) days
 Test results were released and published
simultaneously in Manila and Regional offices
within an average of three (3) days
 Statistical report on performance of Schools
was released to CHED
Professional Regulatory Boards
 PRBs under the Commission are 46 PRBS
which exercise:
 Administrative
 execute and implement
laws
 Quasi-legislative
 draft rules and regulations
to implement laws
 Quasi-judicial powers
 investigate, hear and
decide issues
 Over their respective professions
Functions of PRBs
1. Prepare the contents of licensure
examinations. Determine, prescribe, and revise
the course requirements
2. Recommend measures necessary
for advancement in their fields
 Visit / inspect schools and establishments
for feedback
o To check / monitor the function of
schools
 Adopt and enforce a Code of ethics for the
practice of their respective professions
o March 7, 1991
 Administer oaths and issue Certificate of
Registration
 Investigate violations of set professional
standards and adjudicate administrative and
other cases against erring registrants
o Erring- Capable of making an error
 Suspend, revoke, or reissue Certificate of
Registration for causes provided by law
o Revoke – cancel, invalidate,
withdraw
Professional Regulatory Boards
Professional Regulation Commission
Arellano,Abigail U.
BSMT-2C
 A three-man commission attached to the  ARTICLE V
office of the President of the Philippines o Section 20 - 22
o 1 Fulltime and 2 associate
commissioner ARTICLE I
 To regulate and supervise the practice of
the professionals who constitute the highly CPE Objectives, Definition, Nature and Rationale
skilled manpower of the country
Section I: Objectives
 PRC plays a strategic role in developing the
corps of professionals for industry, commerce,
governance and the economy  CPE Programs objectives:
o Corps - organization o To provide and ensure the
continuous education
o To raise and
PRC RESOLUTION NO. 381
maintain professional’s capability for
STANDARDIZED POLICIES AND PROCEDURES FOR delivering professional services
THE IMPLEMENTATION OF THE CPE PROGRAMS o To attain and maintain the
FOR ALL PROFESSIONS highest standard and quality of the practice
of his profession
o To make the professional
 The CPE of PRBs is under the supervision of
globally competitive
PRC
o To promote the general welfare of
the public
                                               -E.O. no. 266; July 25,
1995
Section 2: Definition
 PRC
 CPE
o issue the necessary standardized
o The inculcation, assimilation and
guidelines and procedures for the
acquisition of knowledge, skills, proficiency,
implementation of the CPE programs for all
ethical and moral values that raises and
professions
enhances the professional’s skills and
professional competence
 ARTICLE I – CPE OBJECTIVES, DEFINITION, o inculcation- instilling/ frequent
NATURE AND RATIONALE
instruction/ repetition
 ARTICLE II – CPE COUNCILS: CREATION,
o Assimilation- absorption
COMPOSITION, TERMS OF OFFICE,
o Acquisition- acquiring
FUNCTIONS, MEETINGS
 ARTICLE III- CRITERIA FOR ACCREDITATION OF
PROVIDERS, PROGRAMS, ACTIVITIES OR Section 3: Nature
SOURCES; EQUIVALENT CREDIT UNITS; CREDIT
REQUIREMENTS; EXEMPTIONS AND OTHER  CPE Programs
MATTERS o Programmed activities
 ARTICLE IV- SANCTIONS o Requiring the participation of
 ARTICLE V- TRANSITORY PROVISION, professionals to meet the requirements for
REPEALING CLAUSE, EFFECTIVITY the renewal of their license
 ARTICLE I
o Section 1 – 4 Section 4: Rationale
 ARTICLE II
o Section 5 - 12  Compliance with CPE program is an
 ARTICLE III effective and credible substitute for requiring a
o Section 13 - 18 professional to pass another examination in
 ARTICLE IV order to allow him to continue his practice
o Section 19

Arellano,Abigail U.
BSMT-2C
  Excretion peaks at 2PM – 4PM
 Same clinical significance as bilirubin
 Frequently caused by constipation
NORMAL URINE LEVEL
• < 1mg/dL or 1 EHRLICH UNIT
• 0.5 – 25 mg/units/24 hours
• Reported as NORMAL - never as negative

LABORATORY RESULTS TYPE OF

JAUNDICE URINE BILIRUBIN

LAB TESTS FOR UROBILINOGEN

Reagent Strip – Ehrlich’s reaction
Ehrlich’s Tube Test
-Nonspecific
-Can be used for testing for :
 Indicant
 Sulfonamides
 P- aminosalicylic
 Porphobilinogen
Reagents:
 P-dimethylaminobenzaldehyde
 Sodium acetate

CM Lecture 6: CHEMICAL
Hoesch Test
-Inverse Ehrlich
EXAMINATION
-Rapid screening test for urine porphobilinogen
(UROBILINOGEN, NITRITE, & LEUKOCYTE
(≥ 2mg/dL)
ESTERASE)
Principle:
–Urobilinogen is inhibited by acidic pH
UROBILINOGEN
• Reagent –HOESCH REAGENT
 Urobilinogenuria  Hoesch reagent – Ehrlich reagent dissolved in
 A colorless pigment formed from the 6M HCl
breakdown of bilirubin in the intestines
 Appears in urine because as it circulates in the Watson-Schwartz Differentiation Test
blood on route to the liver, it may pass through -Classic test to DIFFERENTIATE UROBILINOGEN
the kidney and be filtered by the glomerulus. FROM PORPHOBILINOGEN

Arellano,Abigail U.
BSMT-2C
-Based on solubility characteristics of urobilinogen -detects bacteria capable of reducing nitrate to
and porphobilinogen with respect to pH and solvent nitrite
type -Most common organism that infect the urinary
- The layer in which the red chromophore resides tract:
identifies the substance present  Proteus spp.
 E.coli
UROBILINOGEN  Klebsiella pneumonia
- SOLUBLE in both butanol and chloroform  Pseudomonas aeruginosa
PORPHOBILINOGEN 
-INSOLUBLE in both butanol and chloroform
OTHER EHRLICH REACTIVE
COMPOUNDS LEUKOCYTE ESTERASE
-SOLUBLE in butanol and INSOLUBLE in chloroform • Indicates the following,
 Pyuria
 Kidney inflammation
 Urinary tract inflammation
 Detects the presence of esterase in
Neutrophils, Eosinophils,
Basophils, Monocytes,
Trichomonas and Histiocytes.
 Bacteria, lymphocytes, erythrocytes and
renal tissues – does not contain LE
 Not designed to measure leukocyte
concentration
Miscoscopic Examination
 used or quantification of LE
 -Count WBC/ HPF

ASCORBIC ACID (VITAMIN C)

-Source of interference due to its STRONG
REDUCING PROPERTY leading to FALSE
NEGATIVE results
WATSON-SCHWARTZ DIFFERENTIATION - Hydrogen donor which causes it to readily
TEST
oxidize into DEHYDROASCORBI ACID, a colorless
compound.
-Reagent strip tests that use Hydrogen
Peroxide (H2O2) or a diazonium salt are subject
to ascorbic acid interference
-The compound meant to be detected by the
reagent strip are removed by ascorbic acid, this
prevents any intended reaction.
-As a result of this, DEHYDROASCORBIC ACID is
produced from ascorbic acid.
NITRITE
-Rapid (Indirect) screening test for the presence of Affects the following parameters:
UTI or asymptomatic

Arellano,Abigail U.
BSMT-2C
  Blood
 Bilirubin
 Leukocyte esterase
 Nitrite
 Glucose
LAB TESTS FOR ASCORBIC
ACID (VITAMIN C)
C-Stix
KETONES REACTION
 Reagent strip tests use the sodium nitroprusside
 Impregnated with PHOSPHOMOLYBDATES
or nitroferricyanide reaction to measure
buffered in an acid medium
ketones.
 Ascorbic acid reduces PHOSPHOMOLYBDATES
into molybdenum blue  In this reaction, acetoacetic acid in an alkaline
 Detects 5mg/dl of Ascorbic Acid after 10 sec medium reacts with sodium nitroprusside to
produce a purple color.
CAUSES OF FALSE POSITIVE
 Gentisic acid
 L-dopa

Stix and Multistix

 Impregnated with METHYLENE GREEN
 Ascorbic acid reduces METHYLENE GREEN into
colorless form
 Detects 25 mg/dL of Ascorbic Acid at 60
seconds
pH REACTION
 The Multistix and Chemstrip brands of reagent
strips measure urine pH in 0.5- or 1-unit
increments between pH 5 and 9.
 Uses a double-indicator system of methyl red
and bromothymol blue.
 Methyl red produces a color change from red to
yellow in the pH range 4 to 6

REAGENT STRIP
SPECIFIC GRAVITY
REACTIONS
REACTION
Glucose Oxidase  Based on the change in pKa (dissociation constant) a
 Impregnating the testing area with a mixture of polyelectrolyte in an alkaline medium.
 The polyelectrolyte ionizes, releasing hydrogen ions in
o Glucose oxidase
proportion to the number of ions in the solution.
o Peroxidase
 The higher the concentration of urine, the more
o Chromogen
hydrogen ions are released, thereby lowering the pH.
o Buffer

• To produce a double sequential enzyme reaction

Arellano,Abigail U.
BSMT-2C

PROTEIN REACTION
-Based on protein error of indicators
BLOOD REACTION
 Chemical tests for blood use the pseudoperoxidase
activity of hemoglobin to catalyze a reaction between
the heme component of both hemoglobin and
myoglobin and the chromogen tetramethylbenzidine
to produce an oxidized chromogen, which has a
green-blue color.
 Color change is from ORANGE to GREEN to DARK
BLUE
BILIRUBIN REACTION
 Uses diazo reaction
 Bilirubin combines with 2,4-dichloroaniline
diazonium salt or 2,6-dichlorobenzene-diazonium
tetrafluoroborate in an acid medium to produce an
AZODYE-TAN or PINK to VIOLET
UROBILINOGEN REACTION
Multistix
 Uses Ehrlich’s aldehyde reaction
 Urobilinogen reacts with p-dimethylaminobenzaldehyde
(Ehrlich reagent) to produce colors ranging from light
to dark pink.
 Results are reported as Ehrlich units (EU) = mg/dL
Chemstrip
 Uses azo-coupling (diazo) reaction using
4-methoxybenzenediazonium- tetrafluoroborate to
react with urobilinogen
 Produces colors ranging from white to pink
 More specific for urobilinogen than Ehrlich reaction
LEUKOCYTE ESTERASE
REACTION
 Uses the action of LE to catalyze the hydrolysis of an
acid ester embedded on the reagent pad to produce
an aromatic compound and acid.
 the aromatic compound then combines with a
diazonium salt present on the pad to produce a
PURPLE AZODYE

Arellano,Abigail U.
BSMT-2C