1 Introduction to Clinical Pathology

Clinical Laboratory

Plays a central role in health care

70% of all medical decisions are based on laboratory

results (Silverstein, 2003)

Philippines: Low national budget for healthcare =

Limited funds for government hospital laboratories

A facility where tests are done on specimens from the

human body to obtain information about the health
status of a patient for the prevention, diagnosis and
treatment of diseases. This tests include, but are not
limited to, the following disciplines: clinical chemistry,
hematology, immunohematology, microbiology,
immunology, clinical microscopy, histopathology,
cytology, toxicology, endocrinology, molecular
pathology and cytogenetics.
Purpose of the Laboratory (Kurec, 2000)

To provide clinicians and other healthcare

professionals with information to:
Detect disease or predisposition to disease
Confirm or reject a diagnosis
Establish prognosis
Guide patient management
Monitor efficacy of therapy
Indications for Ordering Laboratory Examinations

To confirm a clinical impression or to establish a

diagnosis

To rule out a diagnosis

To monitor therapy (management guide)

To establish prognosis

To screen for or to detect disease

Clinical Laboratory Management

Effective leadership provides the direction of where

the organization is going, whereas management
provides the road to get there (to get things done)
Leader versus Manager Traits
Leader
Administrator
Organizer and developer
Risk-taker
Inspiration
Thinks long term
Asks what and why
Challenges status quo
Does the right thing

Manager
Implementer
Maintains control
Thinks short term
Asks how and when
Watches bottom line
Accepts status quo
Is good soldier
Does things right

Basic Management Responsibilities

Operations
Human Resource
Management
Management
Quality assurance
Job descriptions
Policies and procedures
Recruitment and staffing
Strategic planning
Orientation
Benchmarking
Competency assessment
Productivity assessment
Personnel records
Legislation/regulations/HPP
Performance
A compliance
evaluation/appraisals
Medicolegal concerns
Discipline and dismissal
Continuing eduction
Staff meeting

Financial Management
Department budgets
Billing
CPT coding
ICD-9 coding
Compliance regulations
Test cost analysis
Fee schedule maintenance

Marketing Management
Customer service
Outreach marketing
Advertising
Website development
Client education

Government (DOH) Rules & Regulations

Republic Act No. 4688 s. 1966, An Act Regulating the

Operation and Maintenance of Clinical Laboratories
and Requiring the Registration of the Same with the
Department of Health, Providing Penalty for the
Violation Thereof, and for Other Purposes

Administrative Order No. 59 s. 2001, Rules and

Regulations Governing the Establishment, Operation
and Maintenance of Clinical Laboratories in the
Philippines

Administrative No.0027 s. 2007 Revised Rules and

Regulations Governing the Licensure and Regulation
of Clinical Laboratories in the Philippines
Classification of Clinical Laboratories

Classification of Ownership
Government
Private

Classification of Function
Clinical Pathology
Anatomic Pathology

Classification by Institution Character

Institution-based
Freestanding

Classification by Service Capability

General Clinical Laboratory

Primary Category

Secondary Category

Tertiary Category

Limited Service Capability

Special Clinical Laboratory
Laboratory Service Model Examples

Primary Laboratory

Secondary Laboratory

Tertiary Laboratory

National Reference Laboratory

Stat Laboratory

Point-of-Care
Human Resource

Every clinical laboratory shall be headed and

managed by a pathologist, certified either as a Clinical
Pathologist, an Anatomic Pathologist, or both by the
Philippine Board of Pathology

There shall be an adequate number of medical

technologists and other health professionals with
documented training and experience to conduct the
laboratory procedures

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Equipment/Instrument
Primary Category
Clinical centrifuge
Differential blood cell counter or its
equivalent
Hemacytometer
Hemoglobinometer or its equivalent
Microhematocrit centrifuge
Microscope with oil immersion objective

Physical Plant
Primary Category
Minimum of 10 square meters in floor area
Access to Toilet
Clinical Work Area with Sink
Pathologist Area

Secondary Category
All those in Primary Category PLUS the
following:
Photometer or its equivalent
Refrigerator
Timer or its equivalent
Water bath or its equivalent

Tertiary Category
All those in
Secondary Category PLUS the following:
Autoclave
Balance, trip/analytical Biosafety cabinet
or its equivalent
Drying oven
Incubator
Rotator
Serofuge or its equivalent

Secondary Category
Minimum of 20 square meters in floor
area

Tertiary Category
Minimum of 60 square meters in floor
area

Toilet
Clinical Work Area with Sink
Pathologist Area

Toilet
Clinical Work Area with Sink
Pathologist Area
Microbiology Room

Laboratory Design

Traditional Closed Laboratory

Open Laboratory

Core Laboratory, e.g. Chemotology Lab

External Quality Assessment Program (EQAP)

It is a program where participating laboratories are

given unknown samples for analysis. These samples
are to be treated as ordinary human specimens for
the usual processing and examination.
National Reference Laboratory (NRL)

It is a laboratory in a government hospital which had

been designated by the DOH to provide special
functions and services for specific disease areas.

These functions include provision of referral services

such as confirmatory testing, surveillance, resolution
of conflicting results between or among laboratories;
training; research, implementation of EQAS;
evaluation of diagnostic kits and reagents

VMMC OPD Satellite Laboratory

Administrative Policies and Procedures

The clinical laboratory shall have written policies and

procedures for the provision of laboratory services
and for the operation and maintenance of the
laboratory
Technical Procedures

There shall be documented technical procedures for

services provided in each Section of the laboratory,
which will ensure the quality of laboratory results
Quality Assurance Programs

There shall be an Internal Quality Assurance Program

which shall include:
An Internal Quality Control Program for
technical procedures
An Internal Quality Assurance Program for
inputs, processes and outputs
A Continuous Quality Improvement
Program (CQIP) covering all aspects of
laboratory performance

The clinical laboratory shall participate in an EQAP

administered by designated NRL or in other local and
international EQAP approved by the DOH

National Reference Laboratories

National Kidney and Transplantation Institute (NKTI)

East Avenue Medical Center (EAMC)

STDs and AIDS Cooperative Central Laboratory

(SACCL)

Research Institute for Tropical Medicine (RITM)

Lung Center of the Philippines (LCP)

Philippine Heart Center (PHC)

Point of Care Testing (POCT)

Other terms:
Alternative-site testing
Near-patient Testing
Bedside Testing
Decentralized Testing

Definition: Laboratory testing at or near the site of

patient care (Ward, OR, ICU, EW, clinic) rather than in
the clinical laboratory and includes testing at the
bedside, outpatient sites, within or outside the
hospital or clinics or at home.

Device Used: Small handheld instrument that

measure one or two or a full panel of analytes,e.g.,
Urine or blood glucose, ABG, electrolytes, PT, PTT,
pregnancy tests, hemoglobin

rainwater@mymelody.com || 1st semester, AY 2011-2012

Advantages:
More rapid ( 5 minutes) provision of lab
results, ie., shorter laboratory TAT
Faster assessment of health status
Shorter therapeutic TAT
Decreased morbidity and mortality
Government (DOH) Regulation
Administrative Order No. 0027, s. 2007,
Section VI A.6. states that a POCT,
conducted in a hospital, is required to be
under the management and supervision of
the licensed clinical laboratory of the
respective laboratory

Regulation, Accreditation, Legislation

License to Operate (LTO)

Mandatory requirement for all clinical
laboratories and administered by a
government agency, e.g. BHFS, under a
legislative authority

Accreditation
Voluntary and administered by a
government agency or a non-government
organization in order to improve and
standardize the quality of services of the
clinical laboratories in the country
Examples of accreditation schemes

DOH-QMS, DTIPAO(PNS)

ISO 9001: 2001, ISO-15189:2007,

JCAHO, JCI, CAP
DTI- Phil. Accreditation Office

PNS ISO 15189:2010 Medical Laboratories particular

requirements for quality and competence (ISO
published 2007)

PNS ISO 22870:2010 Point-of-care testing (POCT)

Requirements for quality and competence (ISO
published 2006

PNS ISO/TS 22367:2010 Medical laboratories

Reduction of error through risk management and
continual improvement (ISO published 2008)

PNS ISO/TR 22869:2010 Medical laboratories

Guidance on laboratory implementation of ISO
15189:2003

Laboratory Test Processes

Pre-analysis

Analysis
Total Laboratory Automation

Post-Analysis
Laboratory Errors

Pre-analytic errors
Hemolyzed, clotted or insufficient samples
Incorrectly identified or unlabeled samples
Wrong collection tube drawn
Improper specimen storage

Analytic errors
Calibration errors
Instrument malfunction

Post-analytic errors
Reports sent to the wrong physicians
Long Turn-Around Time (TAT)
Missing reports
Clinical Laboratory Informatics

The clinical lab as one of the most data-intensive

areas of the hospitals and the first to computerize
information handling and test generation

Clinical Laboratory Informatics that aspect the

practice of pathology which focuses on the
management of information and systems in support
of patient care decision-making, education and
research (Balis 1993)

Laboratory Information System (LIS) supports

workflow and information flow in all steps of the
laboratory testing process

Components of a single-beam spectrophotometer. A, exciter lamp; B, entrance slit; C, monochromator; D, exit slit, E, cuvet;
F, photodetector; G, LED display

rainwater@mymelody.com || 1st semester, AY 2011-2012

rainwater@mymelody.com || 1st semester, AY 2011-2012

Components of a Flowcytometer

Decision Matrix

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LIS Functions

Pre-analysis
Patient registration
Test ordering
Phlebotomy draw lists
Specimen tracking/racking system

Analysis
Instrument worklist
Manual results entry
Automated results entry via interface
Result validation and manual or automatic
release
Quality control

Post-analysis
Requisition-based patient reports (final,
partial)
Cumulative patient reports
Corrected report
Results inquiry
Electronic reporting to external interfaced
systems, e.g. HIS, billing

Management
Pending (incomplete) list
Turnaround time reports
Workload statistics
Ad hoc report writer
HIS and instrument integrity monitoring
tools
Laboratory Safety

Biological Hazards
Tuberculosis, Hepatitis B/C, HIV infection/
AIDS
CDC Universal Precautions

Chemical Hazards
OSHA Chemical Hazard Communication
Plan


Material Safety Data Sheet
(MSDS)

Ergonomic Hazards
Cumulative trauma disorders eg. Back
injuries

Fire Hazards

National Fire Protection Rating System

Health Hazard (blue)

0 = No hazard

1 = Can cause irritation if left untreated

2 = Can cause injury. Requires prompt treatment

3 = Can cause serious injury despite medical

treatment

4 = Can cause death or major injury despite medical

treatment
Flammability (red)

0 = Will not burn

1 = Ignites after considerable preheating

2 = Ignites if moderately heated

3 = Can be ignited at all normal temperature

4 = Very flammable gases or very volatile flammable

liquid
Reactivity (yellow)

0 = Normally stable. Not reactive with water

1 = Normally stable. Unstable at high temperature

and pressure. Reacts with water.

2 = Normally unstable but will not detonate

3 = Can detonate or explode, but requires strong

initiating force or heating.

4 = Readily detonates or explodes

Other (white)

In the diamond designated other (white) one

might use the following descriptions:
o OX = Oxidizer
o ACID = Acid
o ALK = Alkali
o COR = Corrosive
o -W- = Use no water
HAZARD WARNING SYMBOLS

rainwater@mymelody.com || 1st semester, AY 2011-2012