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01 - Introduction to Clinical Pathology
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[email protected] || 1st semester, AY 2011-2012
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
[email protected] || 1st semester, AY 2011-2012
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
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
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
[email protected] || 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, 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
[email protected] || 1st semester, AY 2011-2012
[email protected] || 1st semester, AY 2011-2012
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