01 - Introduction to Clinical Pathlogy

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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 Manager

Administrator Implementer

Organizer and developer Maintains control

Risk-taker Thinks short term

Inspiration Asks how and when

Thinks long term Watches bottom line

Asks what and why Accepts status quo

Challenges status quo Is good soldier

Does the right thing Does things right

Basic Management Responsibilities

Operations

Management

Human Resource

Management

Quality assurance Job descriptions

Policies and procedures Recruitment and staffing

Strategic planning Orientation

Benchmarking Competency assessment

Productivity assessment Personnel records

Legislation/regulations/HPP

A compliance

Performance

evaluation/appraisals

Medicolegal concerns Discipline and dismissal

Continuing eduction

Staff meeting

Financial Management Marketing Management

Department budgets Customer service

Billing Outreach marketing

CPT coding Advertising

ICD-9 coding Website development

Compliance regulations Client education

Test cost analysis

Fee schedule maintenance

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


Equipment/Instrument

Primary Category Secondary Category Tertiary Category

Clinical centrifuge

Differential blood cell counter or its

equivalent

Hemacytometer

Hemoglobinometer or its equivalent

Microhematocrit centrifuge

Microscope with oil immersion objective

All those in Primary Category PLUS the

following:

Photometer or its equivalent

Refrigerator

Timer or its equivalent

Water bath or its equivalent

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

Physical Plant

Primary Category Secondary Category Tertiary Category

Minimum of 10 square meters in floor area Minimum of 20 square meters in floor

area

Minimum of 60 square meters in floor

area

Access to Toilet

Clinical Work Area with Sink

Pathologist Area

Toilet


Pathologist Area

Toilet


Pathologist Area

Microbiology Room

Laboratory Design

• Traditional “Closed” Laboratory

• “Open” Laboratory

• Core Laboratory, e.g. Chemotology Lab

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

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

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


• 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, DTI–PAO(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



Components of a Flowcytometer

Decision Matrix


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

Documents

01 - Introduction to Clinical Pathlogy