Laboratory management

1
Compiled By
SIGMA DIAGNOSTICS
YAMUNA NAGAR – 135001,
HARYANA, INDIA 93551-24000

2
Compiled By SIGMA DIAGNOSTICS YAMUNA NAGAR – 135001, HARYANA, INDIA 93551-24000, 93150-24000

Essential to all aspects of health care are
laboratory results that are:
accurate
reliable
timely
3

Achieving a level of quality
means
accepting a error rate1%
4

5

unnecessary treatment; treatment
complications
failure to provide the proper treatment
delay in correct diagnosis
additional and unnecessary diagnostic
testing 6

coordinated activities to direct and control
an organization with regard to quality
(ISO,CLSI)
ALL aspects of the laboratory operation
need to be addressed to assure quality;
this constitutes a quality management
system
7

•Data & Laboratory
Management
•Safety
•Customer Service
Patient/Client Prep
Sample Collection
Sample Receipt and
Accessioning
Sample Transport
Quality Control
Testing
Record Keeping
Reporting
Personnel Competency
Test Evaluations
8Compiled By SIGMA DIAGNOSTICS YAMUNA NAGAR – 135001, HARYANA, INDIA 93551-24000, 93150-24000

THE PATIENT Test selection Sample Collection
Sample Transport
Laboratory Analysis
Examination Phase
Report CreationReport Transport
Preexamination Phase
Result Interpretation Post examination Phase

10
The entire process of managing a sample
must be considered:
• The beginning: sample collection
• The end: reporting and saving of results
• All processes in between

human resources
job qualifications
job descriptions
orientation
training
competency assessment
professional development
continuing education
11

safe working environment
transport management
containment
security
waste management
laboratory safety
ergonomics 12

acquisition
installation
validation
maintenance
calibration
troubleshooting
service and repair
records
13

quality control
sample management
method validation
method verification
Process Control
14

confidentiality
requisitions
logs and records
reports
Information Management
computerized laboratory
information systems (LIS) 15

creation
revisions and
review
control and
distribution
Documents Records
collection
review
storage
retention
16

complaints
mistakes and problems
documentation
root cause analysis
immediate actions
corrective actions
preventive actions
Occurrence Management
17

INTERNAL
Quality Indicators
Audit Program
Laboratory Assessment
EXTERNAL
Proficiency
Testing (EQA)
Inspections
AccreditationsAudit Review
18

customer group identification
customer feedback
customer needs
Customer Service
19

Implementing
Quality Management
an
Laboratory 20

Standards Organizations
ISO
International Organization
for Standardization
CLSI
Clinical and Laboratory
Standards Institute
(formerly known as NCCLS)
Guidance for quality in
manufacturing and service
industries
Standards, guidelines, and
best practices for quality in
medical laboratory testing
Broad applicability; used
by many kinds of
organizations
Detailed; applies
specifically to medical
laboratories
Uses consensus process in
developing standards
Uses consensus process in
developing standards 21

exercising responsible
authority, while
providing motivation and
vision
influencing and
encouraging staff
to good performance

Organizational Structure
establish a working structure that
ensures sufficiency at all parts in the
laboratory work flow
designate responsibilities and roles;
develop an organization chart
designate a Quality Manager
allocate sufficient resources 23

LABORATORY
DIRECTOR
CHARGE
TECHNOLOGIST
ASSISTANT
CHARGE
TECHNOLOGIST TECHNOLOGIST
QUALITY
MANAGER
NURSING
DIRECTOR
NURSING
HOSPITAL DIRECTOR

Quality Manager
ISO 15189 requirement
has responsibility and authority to oversee
compliance
reports directly to the decision-making
level of laboratory management

Quality Manager Responsibilities
monitor quality management system
assure compliance
review all records
conduct, coordinate audits
investigate deficiencies

Gap Analysis: Common Problems Identified
test ordering
sample management
training level (competence)
of technical staff
quality control
analytical process
recording and reporting results

FACILITIES
AND SAFETY
28

Learning Objectives
relate how facility design impacts the
efficiency and safety of laboratory workers
describe practices to prevent or reduce
risks
describe steps to take in response to
emergencies
list personal protective equipment (PPE)
that should be used routinely

Effects of Laboratory Accident
loss of staff confidence
loss of reputation
loss of customers
increased cost --- litigation, insurance
Negligence
of laboratory safety is
costly!
30

is responsible for quality and safety 31

Laboratory Design
path followed by the sample
• reception and registration of patients
• sampling rooms
• dispatch between different laboratories
• analysis of samples
report delivery, filing
service rooms 32

Blood clotting
Hematology
Biochemistry
Wash
room
Bacteriology
Gynaecological
samples
Blood
samples
Common room,
stairs to offices
Disinfection
Laboratory Design 33

Registration Desk
34

Blood
clotting
Hematology
Biochemistry
Wash
room
Bacteriology
Gynaecological
samples
collection
Blood
samples
collection
Common room,
stairs to offices
Disinfection
Waste
Reception

Premises
high ceiling with good ventilation
use washable, glossy paint
easy to clean and disinfect
walls and ceiling
floor
easy to clean and disinfect 36

Benchtops
non-porous covering, easy to clean,
resistant to chemicals and disinfectant
no wood, no steel
37

Scheduled Cleaning
daily
• bench tops
• floors
weekly
• ceilings, walls
others
• refrigerators, freezers, storage areas
38

General Safety Equipment
fire safety PPE
waste disposal

Standard Safety Practices
40

Standard Safety Practices
41

Safety Signs
42

Laboratory Hazards
physical
chemical
biological
43

Physical Hazards
44

do not recap needles
always use puncture-resistant,
leakproof,
sharps containers
always use specific waste
disposal containers
never directly handle broken
glass
45

46

Do you see anything wrong?
47

Do NOT reuse disposable injection equipment
48

separate cabinets for storage
spill containment cabinet
hazardous waste storage
Chemical Hazards
flammable liquids storage 49

Material Safety Data Sheet
50

aerosols and droplets
Biological Hazards
ocular invasion
inhalation
ingestion
skin penetration
51

Laboratory Fire Safety
52

53

Laboratory Staff
laboratory’s greatest asset
critical to quality
partners in public health
qualified professionals
54

Personnel
Management
Job
Descriptions
Orientation
Training
Competency
Assessment
Continuing
Education
Performance
Appraisal
55

Orientation
Competency Assessment
Task-specific Training
Competency Recognition
Job Description
Qualified New Employee
Retraining

Reduces
interruption
of services
Increases safety
Greater
customer
satisfaction
Equipment Management Benefits

Selecting and Acquiring Equipment
easy to use
language
warranty
safety
will it fit?
59

Negotiating Equipment Acquisition
wiring diagrams
software information
parts list
operator manual
installation by
manufacturer
trial period
60

Before Equipment Installation
confirm vendor’s responsibilities in
writing
establish checklist
61

Equipment Installation
when possible, have manufacturer install
and set up
do not attempt to
use prior to proper
installation
verify package
contents
copy software,
if part of system 62

After Equipment Installation
Inventory
Record
Calibration Verification
Operating
Procedures
Maintenance Program
Train ALL Operators 63

• perform initial calibration
– use calibrators or
standards
– follow manufacturer’s
instructions
• determine frequency of
routine calibrations
Equipment Calibration
64

Performance Evaluation
Test known samples,
analyze data
Establish stability
for temperature-
controlled
equipment
Validate
performance with
parallel samples
NEW EQUIPMENT
65

Preventive Maintenance
routine cleaning
adjustment,
replacement of
equipment parts
66

Function Checks
Monitor instrument parameters:
– periodically, daily, weekly, monthly
– after major instrument repair
Examples:
– incubator temperatures
– wavelength calibration
– autoclave temperature chart
67

Create an Equipment Inventory Log
instrument type, model number,
serial number
location in laboratory
date purchased
manufacturer and
vendor contact info
warranty, spare parts
68

Troubleshooting
What is the source of the
problem?
• Sample?
• Reagent?
• Water, Electricity?
• Equipment?
69

When in-house efforts fail:
• call manufacturer or
other technical expert
• look for options to continue service
 obtain back-up instrument from
central
stores or manufacturer
 refer sample to nearby laboratory
70

manufacturers
laboratory must schedule routine manufacturer’s
maintenance
warranty may require repair handled by
manufacturer
in-house biomedical
service technicians
Service and Repair

Recording Problems
date problem occurred, equipment removed
from service
reason for breakdown or failure
corrective actions taken
date returned to use
change in maintenance or in function
checks 72

Example of logbook 1
73

74

75

PURCHASING
AND INVENTORY
76

Benefits of an Inventory
Management Program
Quality
Maintained
Minimize waste
Stay within
budget
Supplies and
reagents always
available
77

Inventory Management
Challenges
balance between stock
availability
and expiration dates
life-span of laboratory
reagents varies
In-
stock
Expiry
Date
78

Establish a System to Qualify and
Select Vendors
define criteria for supplies and services to be
purchased
use information from other laboratories
evaluate before purchase and after receipt
79

Determine
payment
mechanisms
Negotiate
prices
Review
Contracts
Understand government
requirements
Assure reliable
availability, delivery
Purchasing Considerations

INVENTORY
CONTROL
Assign
responsibility
Analyze
needs
Establish
minimum stock
needs
Develop
forms and logs
Establish
system for
receiving, storing
Maintain
inventory system
in all storage
areas
How to Implement Inventory Control

Analyze Needs
listing all tests in the laboratory
identifying all supplies needed for each
test
using available information to estimate
usage
82

Quantification: How?
consumption-based method
morbidity-based method
83

Quantification:
Consumption-Based
based on actual usage
must take into account:
• health-supplies actually used
• waste: expired or spoiled supplies
• supplies out of stock for more than 15
days during any time of year 84

0
10
20
30
40
50
60
70
80
90
1st
Qtr
2nd
Qtr
3rd
Qtr
4th
Qtr
Slides
Immersion Oil
Collection
containers
85

Quantification:
Morbidity-Based
based on actual number of episodes
must take into account:
• population size
• disease incidence
• accuracy of morbidity data
• treatment guidelines 86

0
20
40
60
80
100
120
140
160
180
1st Qtr 2nd Qtr 3rd Qtr 4th Qtr
Influenza
Diarrhea
TB
87

Inventory Control:
Documentation
Maintain records:
 date received
 lot number
 pass or fail acceptance criteria
 date placed in service or disposition
May be useful to keep
records in stockroom.

Includes:
 name and signature
 date of receipt
 quantity
 date of expiry
 minimum stock
 stock balance
Other information:
– shelf number
– destination
89

inspect new orders at time of delivery
• verify contents
• check integrity
• record date each item received
• record expiration date
• store new shipment behind
existing shipment
• create or update records
90

Use clearly visible dating labels
date opened
date expired
91

Continuous Monitoring of
Inventory
Inventory
Control
Assign
responsibility
Maintain
inventory system
in all storage
areas
Conduct weekly
physical counts
Update
records
92

Computerized Stock Management
advantages
• exact current state of stock
• management of expiration dates
• makes inventory tasks easier
drawbacks
• on-site computer is needed
• requires trained staff
93

94

The result of any laboratory
examination is only as good as the
sample received in the laboratory.
95

96

Components
Collection,
preservation
Labeling
Assessing,
processing,
tracking
Retention,
storage,
disposal
Transport
Information
needed
Laboratory
Handbook
Policies & Practices
97

• contains information needed by those
who collect samples
• available to all sample collection areas
• must be understood by
all laboratory staff
• referenced in
the quality manual
Laboratory Handbook
98

Laboratory Handbook
 name and address of laboratory
 contact names and telephone numbers
 hours of operation
 list of tests that can be ordered
 sample collection procedures
 sample transport procedures
 expected turn around times (TAT)
 how urgent requests are handled
99

Define a good
labeling systemAssess all samples -
preexamination
Provide sample
collection information
What- When- How
Provide appropriate
containers and supplies
The Laboratory’s Responsibilities

Laboratory management

Recomendados

Recomendados

Más contenido relacionado

La actualidad más candente

La actualidad más candente (20)

Destacado

Destacado (20)

Más de Satish Kamboj

Más de Satish Kamboj (10)

Último

Último (20)

Laboratory management