The document discusses key concepts in clinical laboratory management including leadership, quality management, safety, and regulations. Effective management requires both leaders to provide direction and managers to implement processes. Laboratories must balance various hazards through work practices, engineering controls, and personal protective equipment. Quality is ensured through approaches like total quality management, continuous quality improvement, and six sigma. Human resource management and strategic planning are also important aspects of running a successful clinical laboratory.

1. PART I
THE CLINICAL
LABORATORY
Mar-Jay S. Gulapa MD

2. CHAPTER 1
General Concepts
and
Administrative Issues

3. KEYPOINTS
 Effective laboratory management requires
leaders to provide direction and managers to
get things done.
 Most laboratory errors occur in the pre-
analytic and post-analytic stage

4. KEYPOINTS
 Biological, chemical, ergonomic and fire
hazards cannot be completely eliminated
from the laboratory
…..but they can be contained to avoid harm

5. KEYPOINTS
 The laboratory plays a central role in
healthcare
 About 70% of all medical decisions are based
on laboratory results

6. The purpose of the laboratory:
a. detect disease or predisposition to disease
b. confirm or reject a diagnosis
c. establish prognosis
d. guide patient management
e. monitor efficacy of therapy
f. education and research

7. To successfully achieve its goal a
laboratory must use:
a. Medical, scientific, and technical expertise
b. Resources
 personnel, laboratory and data processing
equipment, supplies, and facilities
c. Organization, management, and
communication skills

8. Leadership and Management
 An organization is only as good as its people,
and people are guided by leaders and
managers
 Leadership and Management are often used
interchangeably but represent different
qualities

9.  Leadership provides the direction of where
one (or an organization) is going
 Management provides the ‘road’ to get there
‘If you don't know where you are going,
any road will get you there’

10. Effective management skills
a. Planning and prompt decision-making
b. Organizing
c. Leading
d. Controlling.

11. Traits: Leader versus Manager
Leader Manager
Administrator Implementer
Organizer and developer Maintains control
Risk-taker Watches bottom line
Inspiration Is good soldier
Thinks long term Thinks short term
Does the right thing Does things right

12. Leadership styles
 Supportive Leader
 provides physical and personal resources
 offers flexibility and encourages creative problem
solving
 Directive Leader
 presents rules, orders, or instructions
 offers concise and detailed instructions on how to
complete a task
 Delegating Leader
 provides low support and direction
 Coaching Leader
 provides high support and direction.

13. Management
 uses the human, financial, physical, and
information resources available in the most
efficient and effective manner

14. Manager Stratification
a. First-line managers
 supervisors, team leaders, chief technologists
 more concerned about completing the day's work
b. Middle managers
 operations manager, division head
 engaged in a variety of technical and nontechnical
activities
c. Top managers
 director, CEO, CFO
 strategizing and planning for the next 1-5 years, may
or may not possess technical skills that a first-line
manager uses every day

15. Basic Management Responsibilities
A. Operations management
a. Quality assurance
b. Policies and procedures
c. Strategic planning
d. Benchmarking
e. Productivity assessment
f. Legislation/regulations/HIPPA
compliance
g. Medico-legal concerns
h. Continuing education
i. Staff meetings
B. Marketing management
a. Customer service
b. Outreach marketing
c. Advertising
d. Website development
e. Client education

16. Basic Management Responsibilities
C. Human resource
management
a. Job descriptions
b. Recruitment and staffing
c. Orientation
d. Competency assessment
e. Personnel records
f. Performance evaluation/appraisals
g. Discipline and dismissal
D. Financial management
a. Departmental budgets
b. Billing
c. CPT coding
d. ICD-9 coding
e. Compliance regulations
f. Test cost analysis
g. Fee schedule maintenance

17. Strategic Planning
 Deciding on the objectives of the
organization and changing or modifying
existing objectives
 Allocating resources used to attain objectives
 Establishing policies that govern the
acquisition, use and disposition of these
resources

18. Tactical planning
 detailed, often day-to-day operations needed
to meet the strategic goals that have been
set.

19. SWOT Analysis
- to evaluate the risks associated with new
strategies
a. Strengths
b. Weaknesses
c. Opportunities
d. Threats
environmental
factors INTERNAL
to the lab
environmental
factors EXTERNAL
to the lab

20. SWOT Analysis
Strengths
1. Use current technology/instrumentation
2. Have excess technical capacity
3. Increased test volume will decrease cost per test
4. Strong leadership support
5. Financial resources available

21. Weaknesses
1. Staffing shortage
2. Morale issues
3. Inadequate courier system
4. Need to hire additional pathologist
5. Limited experience in providing multi-hospital/client
LIS services
6. Turnaround times are marginal

22. Opportunities
1. Opening of a new physician healthcare facility
2. Department of Health mandates lead testing on
all children under 2 years old
3. Have access to hospital marketing department
4. Hospital X is bankrupt; laboratory will close

23. Threats
1. Competition from other local hospital labs
2. Competition from national reference labs
3. Reimbursement decreasing
4. Three local hospitals have consolidated their services
including laboratory
5. Several new patient service centers (phlebotomy stations)
already opened

24. Quality Systems Management
 A key management goal is to ensure that
quality laboratory services are provided
 Depends on:
 modern equipment
 well-trained staff
 well-designed physical environment
 good management team

25.  A 1999 study by the Institute of Medicine (IOM)
 44 000 to as many as 98 000 Americans die/year
 due to medical errors
 50% were failure to use appropriate tests
 failure to act on test findings
 delays in rendering a diagnosis

26.  0.05-0.61% laboratory errors
 pre-analytical stage- (32-75%)
 hemolyzed
 clotted or insufficient samples
 incorrectly identified or unlabeled samples
 wrong collection tube drawn
 improper specimen storage
 analytical stage- (13-32%)
 calibration error
 instrument malfunction
 post-analytic stage- reports sent to wrong physician,
long turn-around time and missing reports.

27. Useful approaches to quality
leadership and management

28. Total Quality Management (TQM)
 focuses on teams, processes, statistics, and
delivery of services/products that meet or exceed
customer expectations
 defect prevention- strives to continually look for
ways to reduce errors by empowering employees
 universal responsibility- assist in solving
problems and getting them to understand their
integral role within a greater system

29. Continuous Quality Improvement
(CQI)
 element ofTQM
 strives to continually improve practices and
not just meet established quality standards.

30. Quality Management:
Traditional versus TQM Thinking
Traditional thinking TQM thinking
Acceptable quality Error-free quality
Department focused Organization focused
Quality is expensive Quality lowers costs
Defects caused by workers Defects caused by system
Management controls worker Worker empowered
Status quo CQI
Manage by intuition Manage by fact
Intangible quality Quality defined
We–They relationship Us relationship
End process focus System process
Reactive systems Proactive systems

31. Six Sigma
 popular in the business world and has been
adapted to the laboratory
 sigma or standard deviation expresses how much
variability exists in products or services
 goal of reducing defects to near zero

32.  improve the quality of process outputs by
identifying and removing the causes of defects
(errors) and minimizing variability
 single mantra on ‘improvement’:
 improved performance
 improved quality
 improved bottom line
 improved customer satisfaction
 improved employee satisfaction

33.  number of defects per million opportunities
(DPMO) is measured
 If a lab analyzes 1000 reports and 10 reported late
= 1000÷10=100 0r 1% defect rate
= this is equivalent to 10,000 DPMO
1000 reports 1,000,000 reports
10 reported late X
X= 10,000 DPMO

34.  Most organizations operate at or near four sigma
 CLIA'88 guidelines, proficiency testing (PT) requires
an 80% accuracy rate or 2.4 sigma
 The reported PT accuracy rate for CLIA participating
laboratories was 97% or 3.4 sigma
SIGMA DPMO NON DEFECTIVE
(1mil)-(DPMO)
% YIELD
1 691,463 308,537 30.854%
2.4 200,000 800,000 80%
3.4 30,000 970,000 97%
4 6,210 993,790 99.379%
6 3.4 999,996.6 99.9996%

35. Six Sigma Steps
Six Sigma step Example
1. Define project goal that is critical
to quality
Emergency department results in less
than 30 minutes from order
2. Measure baseline performance and
related variables
Baseline performance:
- 50% of time results are w/i 30 min
- 70% w/i 1 hour
- 80% w/i 2 hours
Variables:
- staffing on each shift
- order to receipt time
- receipt to result time
3. Analyze data using statistics and
graphs to identify and
quantify root cause
Order to receipt is highly variable

36. Six Sigma step Example
4. Improve performance by developing
and implementing a solution
Samples from emergency department
are uniquely colored to make them
easier to spot among routine samples
5. Control the factors related to the
improvement, verify impact,
validate benefits, and monitor
over time
New performance: results available
90% of time within 30 minutes

37. Human Resource Management
 recruiting, hiring, training and retaining
qualified personnel
 average vacancy rate for staff MT -7% (2003)
 difficulties in recruiting and/or retaining staff
because of:
 low wages
 dangerous work environment
 lack of public and professional recognition
 stress

38.  Labor - 50-70% of a laboratory's costs
 new or replacement staff position, or full-time
equivalent (FTE), must be justified criterion-
based job description should be developed
 Criterion-based job description
 focus on:
a. roles and not specific tasks
b. clear identification of responsibilities
c. accountability
d. internal and external organizational relationships

39. Laboratory Design and Service Model Examples
A.Traditional ‘closed’ laboratory -has discrete sections in hematology,
chemistry, microbiology, and
blood bank
- separated into rooms /sections
B. ‘Open’ laboratory -discrete services are placed in one
large room with portable walls
that can be adjusted as needed
based on volume

40. Cont…
C. Core laboratory -common type of consolidation has
been hematology and chemistry
laboratories (‘chematology’)
-advantages:
- handling stat requests
- improving off-shift workflow
- avoiding chronic staffing problems
D. Regional laboratory -specific low-volume or expensive laboratory
services currently provided by more than
one regional hospital laboratory, that are
consolidated into one hospital laboratory
-example, consolidation of all virology or PCR
testing into one hospital laboratory

41. Cont….
E. Reference laboratory -traditional full service laboratory that
handles all types of testing,
especially esoteric tests
F. Point-of-care -laboratory testing that is brought to
the patient's bedside
-test menu - limited to a few basic
chemistry and hematology tests -
- e.g., glucose, pregnancy, activated
clotting time, blood gases

42. Cont….
G. Stat laboratory - rapid response laboratory
- located in or near an emergency
department or surgical suite
-provides critical laboratory tests such
as hematocrits and blood gases
H. Limited service -limited menu of routine and specialty
services on a stat or non-stat basis
- downsized hospital labs that retain
stats and some routine tests but
send most work to an off-site core
laboratory

43. Laboratory Physical Design Considerations
1. In developing a needs assessment, identify space for offices, personal
facilities, storage, conference/library area, and students.
2. Routinely review all floor plans and elevations for appropriate usage and
ensure space and function are related. Handicap accessibility may be
required .
3. Develop and use a project scheduler
4. Fume hoods and biological safety cabinets must be located away from
high traffic areas and doorways

44. Laboratory Physical Design Considerations
5. Modular furniture allows for flexibility in moving or reconfiguration of the
laboratory according to current and anticipated needs
6. Conventional laboratory fixtures may be considered in building
depreciation
7. Base cabinets (under laboratory counters) provide 20–30% more storage
space than suspended cabinets
8. Noise control in open labs may be obtained by installing a drop ceiling.
Installation of utilities above a drop ceiling adds to flexibility in their
placement

45. Laboratory Physical Design Considerations
9. In general, space requirements are 150–200 net square feet (excludes
hallways, walls, custodial closets, etc.) per FTE, or 27–40 net square feet
per hospital bed
10. Rooms over 100 square feet must have two exits; corridors used for
patients must be 8 feet wide, while those not used for patients must be 3
feet 8 inches wide
11. An eyewash unit must be within 100 feet of work areas

46. Laboratory Physical Design Considerations
12.Suggested standard dimensions in planning
and designing a laboratory:
a. Laboratory counter width 2 feet 6 inches
b. Laboratory counter to wall clearance 4 feet
c. Laboratory counter to counter clearance 7 feet
d. Desk height 30 inches
e. Keyboard drawer height 25–27 inches
f. Human body standing 4 square feet
g. Human body sitting 6 square feet
h. Desk space 3 square feet

47. Guidelines for Record and Specimen
Retention
Record/specimen type Retention
I. Records
a. Requisitions 2 years
b. Quality control 2 years
c. Blood bank donor/recipient records Indefinitely
d. Blood bank employee
signatures/initials
10 years
e. Blood bank quality control 5 years
II. Reports
a. Clinical pathology lab reports 2 years
b. Autopsy forensic reports Indefinitely
c. Surgical pathology (and BM) reports 10 years
d. Cytogenetics reports 20 years

48. Record/specimen type Retention
Specimens
Serum/other body fluids 48 hours
Blood smears – routine 7 days
Pathology/bone marrow slides 10 years
Pathology Blocks 10 years
Microbiology smears 7 days
Blood bank donor/recipient specimens 7 days post-transfusion
Cytogenetics slides 3 years
Cytogenetics diagnostic images 20 years

49. Safety
Hazards cannot be completely eliminated, but
can be contained to avoid harm
 Exposure to a variety of hazards through
contact with patients, specimens, equipment
and routine daily tasks

50. Laboratory Hazard Prevention Strategies
I. Work practice controls
- general procedures and
preventive measures that reduce
or eliminate exposure to hazards
-Handwashing after each patient
contact
- Cleaning surfaces with disinfectants
-Avoiding unnecessary use of needles
and sharps and not recapping
- Red bag waste disposal
- Immunization for hepatitis
-Job rotation to minimize repetitive
tasks
-Orientation, training and continuing
education
-No eating, drinking, or smoking in
laboratory
-Warning signage

51. Laboratory Hazard Prevention Strategies
II. Engineering controls
- safety features built into the
overall design of a product
-Puncture-resistant containers for
disposal and transport of needles
and sharps
-Safety needles that automatically
retract after removal
-Biohazard bags
-Splash guards
-Volatile liquid carriers
-Centrifuge safety buckets
-Biological safety cabinets and fume
hoods
-Mechanical pipetting devices
-Computer wrist/arm pads
-Sensor-controlled sinks or
foot/knee/elbow-controlled faucets

52. Laboratory Hazard Prevention Strategies
III. Personal protective equipment
(PPE) and barriers
- physically separate the user from
a hazard
-Non-latex gloves
-Gowns and laboratory coats
-Masks including particulate respirators
-Face shields
-Protective eyewear
-Eyewash station
-Chemical-resistant gloves; sub-zero
(freezer) gloves; thermal gloves

53. Hazards
I. Biologic
II. Chemical
III.Ergonomic

54. I. Biological Hazards
 bacteria, viruses, parasites
 Exposure thru ingestion, inoculation, tactile
contamination, or inhalation
 body fluids/tissues, contaminated materials,
lab equipments, aerosol dispersion and
inappropriately disposed waste products

55. Laboratory-associated
infections occurred from:
 mouth pipetting
 consumption of food in laboratory
 spills or splashes on unprotected skin,
membranes, or open cuts
 needlesticks
 Aerosol contamination from inoculating
loops
 spills on laboratory counters

56.  gloves should be used routinely esp. if with
cuts or open
 wash hands after removal of gloves, after any
contact with blood or body fluids, or between
patients
 Gloves should not be washed and reused
since microorganisms that adhere to gloves
are difficult to remove

57.  Masks, protective eyewear, or face shields to
prevent exposure from splashes to the
mouth, eyes, or nose
 laboratory coats must be removed before
leaving the laboratory and never taken home
or outside the laboratory (lunch or personal
breaks)
 Prohibited: Eating, drinking, smoking,
applying cosmetics, or touching contact
lenses

58. Common Decontamination Agents
1. Heat (250°C for 15 minutes)
2. Ethylene oxide (450–500 mg/L @ 55–60°C)
3. 2% Glutaraldehyde
4. 10% Hydrogen peroxide
5. 10% Formalin
6. 5.25% Hypochlorite (10% bleach)
7. Formaldehyde
8. Detergents
9. Phenols
10. Ultraviolet radiation
11. Ionizing radiationPhoto-oxidation

59.  10% solution of common household bleach
- effective and economical disinfectant,
- inactivating HBV in 10 min. and HIV in 2 min.
 all laboratory surfaces must be made of
nonporous material for easy cleaning and
decontamination.

60. What Healthcare Personnel Need to Know
1. Risk of infection depends on The pathogen involved
Type of exposure
Amount of blood involved
Amount of virus in the exposed blood
2. If exposed to blood Wash with soap and water
Flush splashes to nose, mouth or skin
with water
Irrigate eyes with clean water, saline,
or sterile irrigants

61. What Healthcare Personnel Need to Know
3. Risk after an exposure HBV:
- vaccinated: no risk
- unvaccinated : 6–30% risk
HCV: 1.8%
HIV needlestick/cut exposure: 0.3%
HIV exposure to mucosae: 0.1%
HIV exposure
- nonintact skin: 0.1%
- intact skin: no risk
4.Treatment HBV: all healthcare workers should receive
vaccination
HCV: no vaccine and no treatment to prevent
infection
HIV:
- no vaccine available
- antiretroviral drugs
- post-exposure treatment
(within 24 hours -7 days)

62. II. Chemical Hazards
 > 32 million workers exposed to 575 000
potentially hazardous chemicals at work place
 All manufacturers of chemicals should evaluate
the hazards of the chemicals they produce
 employees have the right-to-know what chemical
hazards they are potentially exposed to and
what protective measures the employer needs to
take to minimize hazardous exposure

63. III. Ergonomic Hazards
 Cumulative trauma disorders - group of
injuries involving the musculoskeletal and/or
nervous systems
 constant or excessive repetitive actions,
 mechanical pressure
 vibrations, or compressive forces on the arms,
hands, wrists, neck
 twisting, bending, lifting, or assuming static
postures

64.  Repetitive pipetting, keyboard use, or resting
their wrist/arms on sharp edges, such as a
laboratory counter may cause:
 carpal tunnel syndrome
 tendonitis
 tenosynovitis