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Management
JONNEL P. ANDAYA, RMT
DEFINITION OF MANAGEMENT
“ MANAGEMENT IS THE ART OF GETTING THINGS DONE THROGH PEOPLE “
- MARY PARKER FOLLET
1. FUNCTION OF MANAGER
2. SCIENTIFIC ASPECTS OF MANAGEMENT
3. HUMAN ASPECT AND TREAT PEOPLE AS MERELY MEANS OF GETTINGS
THINGS DONE
4. ROLE OF INTERNAL AND EXTERNAL MANAGEMENT
MORE EFFECTIVE DEFINITION OF
MANAGEMENT
• DESIGNED SKILLS
• ADMINISTRATIVE SKILLS
• DECISION SKILLS
• COMMUNICATION SKILLS
• LEADERSHIP SKILLS
THREE QUALITIES ASSOCIATED WITH
SUCCESSFUL MANAGERS
• NEED TO MANAGE
• NEED FOR POWER
• CAPACITY FOR EMPATHY
MANAGERIAL FUNCTIONS IN
MANAGEMENT
LEADERSHIP AND
MANAGEMENT
JONNEL P. ANDAYA, RMT
LEADERSHIP AND MANAGEMENT
MANAGERS LEADERS
MOYARE SOMEONE WHO: ARE SOMEONE WHO:
MANAGER LEADERS
ADMINISTERS INNOVATES
IS A COPY IS AN ORIGINAL
FOCUSES ON SYSTEM PROCESSES FOCUSES ON PEOPLE
RELIES ON CONTROL INSPIRES
HAS A SHORT RANGE VIEW HAS A LONG RANGE PERSPECTIVE
ACCEPTS THE STATUS QUO CHALLENGES IT
DOES THING RIGHT DOES THE RIGHT THING
CORE VALUES OF A LEADER
INTRODUCTION:
AN ORGANIZATION STRUCTURE IS COMPOSED OF VARIOUS POSITIONS
DESIGNED TO ACCOMPLISH SYSTEMS, GOALS AND OBJECTIVES. A
VARIETY OF MANAGERIAL ACTIVITIES IS ESSENTIAL TO KEEP THOSE
POSITIONS STAFFED WITH PERSONNEL WHO HAVE THE KNOWLEDGE,
THE SKILLS AND THE MOTIVATION TO PERFORM THE ROLES EFFECTIVELY
STAFFING
STAFFING- IS THE PROCESS OF SUPPLYING THE ORGANIZATION WITH THE
NEEDED PERSONNEL TO ACHIEVE THE OBJECTIVES FOR WHICH IT HAS
BEEN ESTABLISHED .
PEOPLE - VITAL COMPONENTS FOR THE EFFECTIVE OPERATION OF THE
ORGANIZATION. MANAGERS OFTEN SAYS THAT PEOPLE ARE THE MOST
IMPORTANT ASSETS
STAFFING AFFECTS LEADING AND CONTROLLING. WELL-TRAINED
MANAGERS SHOULD CREATE AN ENVIROMENT IN WHICH PEOPLE
WORKING TOGETHER IN GROUPS CAN ACHIEVE ORGANIZATIONAL
OBJECTIVES AND AT THE SAME TIME ACCOMPLISH PERSONAL GOALS
FACTORS AFFECTING STAFFING
1.LEVEL OF EDUCATION
2. PREVAILING ATTITUDES TOWARD WORK OF PEOPLE
3. LAWS
4. REGULATIONS THAT DIRECTLY AFFECTS THE PROCESS
5. SUPPLY AND DEMAND FOR PERSONNEL OUTSIDE THE ENTERPRISE .
6. ORGANIZATIONAL GOAL AND OBJECTIVES
7. ORGANIZATIONAL STRUCTURE
8. TASK , TECHNOLOGY THE DIFFERENT KINDS OF PERSONNEL EMPLOYED IN
THE ORGANIZATION
9. DEMAND AND SUPPLY FOR QUALIFIED PERSON WITHIN THE ENTERPRISE
10. VARIOUS POLICIES
EXTERNAL ENVIRONMENT
CAN BE GROUPED INTO:
1. EDUCATIONAL
2. SOCIO-CULTURAL
3. POLITICAL
4. ECONOMIC CONSTRAINTS
5. OPPORTUNITIES
6. HIGH TECHNOLOGIES
INTERNAL ENVIRONMENT
• ROUTINE HEMATOLOGY
1. HEMOGLOBIN MASS CONCENTRATION
2. ERYTHROCYTE VOLUME FRACTION
3. LEUKOCYTE NUMBER CONCETRATION
4. LEUKOCYTE TYPE NUMBER CONCETRATION
• ROUTINE URINALYSIS
• ROUTINE FECALYSIS
• GRAM STAINING
SECONDARY CATEGORY
• WAIVED TEST: TEST CLEARED BY THE FDA FOR HOME USE , EMPLOY SIMPLE
METHODS , LIKELIHOOD OF ERRONEOUS RESULT IS NEGLIGIBLE POSE NO
RISK OR HARM TO THE PATIENT IF THE TEST IS PERFORMED INCORRECTLY
• PROVIDER-PERFORMED MICROSCOPY: THE EXAMINATION PERSONALLY
PERFORMED BY A PRACTIONER;PROCEDURE CATEGORIZED AS MODERATELY
COMPLEX, PRIMARY INSTRUMENT FOR PERFORMING THE TEST IS
MICROSCOPE, SPECIMEN, IS LABILE, CONTROL MATERIALS ARE NOT
AVAILABLE ; SPECIMEN HANDLING IS LIMITED
CLASSIFICATION OF TESTS ACCORDING TO
COMPLEXITY
• HEMOTOLOGY
1. AUTOMATED ANALYSIS
2. DUKE BLEEDING TIME
- MICROBIOLOGY
1. TEST FOR THE PRESENCE OR ABSENCE OF BACTERIA, DERMATOPHYTES
2. DIRECT ACID FAST SMEARS
3. GRAMS STAINS FROM URETHRAL AND ENDOCRINOLOGY
4. BLOOD BANKING METHOLOGY
HIGHLY COMPLEX TEST
HEMOTOLGY:
1. MANUAL METHODS FOR CELL COUNTS AND COAGUALTION
2. PLATELET AGGREGOMETRY
3. DEFFERENTIALS THAT INCLUDE INTERPRETATION OF TYPICAL CELLS
MICROBIOLOGY
1. ALL PROCEDURE REQUIRING IDENTIFYING OF SUSCEPTIBILITY DETERMINATION OF
ORGANISMS AFTER TRANSFER FROM PRIMARY CULTURE MEDIUM
2. GRAMS STAINS FROM SOURCES OTHER THAN URETHRAL OR ENDOCERVICAL
ORIGIN
ALTERNATE SITES OF TESTING:
• Laboratory Aide : Should be at least high school graduate and who shall
assist the Medical Technologist or Laboratory Technician but whose
activities should be limited to non-technician procedures
• Phlebotomist: Person trained in blood collection essential to the health care
team and provides the link between the patient and laboratory
FINANCIAL MANAGEMENT
(OPERATIONAL BUDGET)
JONNEL P. ANDAYA, RMT
OPERATIONAL BUDGET
(TOPICS HIGHLIGHT AND TERMINOLOGIES)
• Example: The laboratory may have a specific plan to examine each year
which services should be performed in-house and which should be sent to
reference laboratory. This would be much more than simply going down the
test menu. Zero-based budgeting starts with the assumption that a service
is not necessary with extensive documentation required to explain why it
must be performed in-house and not dropped in favor of a more productive
options
Budget preparation
• Time frame
• Forecasting stage
• Scheduling stage
Budget Preparation:
Time Frame
Budget Preparation:
Time Frame
Budget Preparation:
Forecasting stage
Budget Preparation:
Scheduling stage
Difference between Budgeting Process of
Government Agencies and Private Agencies
1.Time Criteria: The time frame of capital items is 1 year if product provides
service for more than 1 year, it meets its criteria
2. Price criteria: The dollar value of a project also determines whether it is
budgeted as a capital item or expensed the cut-off amount varies widely and
depends on the accounting policy of the business
Evaluation of Capital budget
Price criteria:
Example: a new heating block costing 200 dollars would meet the other two
criteria for capital items, but because of the low cost and the paper work
requirements, it would probably be handled as a supply expenses for the year
of purchase
Evaluation of Capital budget
• Capital budget are divided into two parts according to the amount of the
expenditures. Projects costing less than a set limit need minimal paperwork
, where those above this amount require extensive dept-analysis. A
common division point is 10,00 dollars.
• Those projects meeting the minimal criteria frequently require only written
justification describing the purpose , function goals and prioritization.
Larger items need more extensive financial analysis.
Certificate of Needs (CON)
• In addition to preparing a capital budget institutions own-used, Federal and
State regulations require health care facilities to submit capital plans on
certain projects for approval and to obtain a certificate of need
authorization before proceeding this process required for projects,
equipment or buildings above as established monetary level. Most states
have set 150,000 dollars following federal guidelines a CON must also be
obtain before new service such as oncology or obstetrics can be offered.
This program was established in an attempt to control spiraling medical cost
and to avoid duplication of services and the over building of hospital beds
Instrument / project capital proposals
2 analysis are used in evaluating capital expenditures
1. Narrative description: or justification of the need and intended use and
qualitative techniques to determine the fianancial feasibility of the
projects
Example : A capital proposals for a small chemistry analyzer costing around
8,000 dollars may need the narrative justification an analyzer costing more
than 10,000 dollars requires a financial feasibility study as well
2. Quantitative techniques to determine the financial feasibility of the project.
Sample narrative tool for justification
Justification
• Rationale or requesting an instrument or building program
1. Explain why the project is needed
2. How it will benefit the laboratory
Proposals can be justified by being grouped into one of four categories:
1. Necessary to maintain present service level
2. Will provide significant savings over current methods
3. will enhance or improve current programs
4. Will offer new procedures or services
PRIORITIZATION
Diagnostic Sensitivity:
Diagnostic Specificity:
Sensitivity(%) = 100 x the number of individuals w/o disease with a negative test
Total number of individuals tested without the disease
Kinds of Quality Control
• Intralab Quality Control ( internal QC):
- It involves the analyses of control sample together with the patient specimens.
- It detects changes in performance between the present operation and the
“stable” operation.
- It is important for the daily monitoring of accuracy and precision of analytical
methods
- It detects both random and systematic errors in a daily basis
- It allows identification of analytical errors within a one – week cycle
- done depends on shifting
Kinds of Quality Control
• The accuracy of any assay depends on the control solutions, how they are
originally constituted and how they remain stable overtime
• General Chemistry assay used 2 level of control solution, while
immunoassay used 3 levels
• To established statistical quality control on a new instrument or on new lot
numbers of control materials , the different levels of control material must
be analyzed for 20 days
Control limits (control values)
• These are expected values represented by intervals acceptable values with upper
and lower limits
• If the expected values are within the desired control limit, the clinicians are assured
that the test result are accurate and precise.
• Control limits are calculated form the mean and standard deviation(SD)
• The idea control/reference limit between +/- 2SD
• Use of single lot for an extended period allows reliable interpretative criteria to be
established which will permit efficient identification of an assay problem.
• When changing to a new lot number, laboratorians use the newly calculated mean
value as the target mean but retain the previous SD value , but when more data are
obtained, all values should be averaged to get estimates of the mean SD
Control limits (control values)
• Variation
Are errors encountered in the collection, preparation and measurement of
samples, including transcription and releasing of laboratory results.
Types of Error:
• Random error: -Is present in all measurements; it is due to chance
- Is a type of error which varies from sample to sample
-Is a basis for varying differences between repeated
measurements - variation in techniques.
- It is due to instrument, operator and environmental
conditions (variations in technique) such as pipetting error,
mislabeling of sample , temperature fluctuation, and improper
mixing of sample and reagents
Types of Error:
• Systematic error: - Is an error influences observations consistently in one
direction (constant differences)
- It is detected as either positive or negative bias-often
related to calibration problems, deterioration of reagents
and control materials , improperly made standard solutions,
contaminated solutions , unstable and inadequate reagent
blanks, leaky ion selective electrode (ISE), failing instrument and poorly
written procedures (impracticability)
- It is measured of the agreement between the measured quantity and
the true value.
Types of Error:
• Constant error: - It refers to a different between the target value and the
assayed value.
- It is Independent to sample concentration
- It exists when there is continual difference between the
Types of Error
• Clerical Error: Is the highest frequency of clerical errors occur with the use of
handwritten labels and request forms.
Statistics:
𝐸(𝑥−𝑚𝑒𝑎𝑛)2
𝑆𝐷 =
𝑛−1
Statistics:
EXAMPLE:
APPLICATION OF STATISTICS IN QUALITY
CONTROL
• STEP 3: TO ESTABLISH THE CONTROL LIMITS SUBSTITUTE THE VALUES IN FORMULAS
BELOW
1SD = SD (+1) + MEAN VALUE
2 SD= SD (+2) + MEAN VALUE
3SD= SD(+ 3) + MEAN VALUE
• It occurs when the data set can be accurately described by the SD and the mean
• It is obtained by plotting the values from multiple analyses of a sample
• It is a population probability distribution that is symmetric about the mean
• It occurs when data elements are centered around the mean with most elements
close to the mean
• It focuses on the distribution of errors from the analytical method rather than the
values from a healthy or patient population.
• The total area under the curve is 1.0 or 100%
Gaussian Curve (Bell-Shaped Curve)
Cumulative Sum graph
• It calculates the difference between QC results and the target means
• Common methods: V- mask
• It identifies consistent bias problems it requires computer implementation
• This plot will give the earliest indication of systematic errors (trend) and can be
used with the 13𝑠 rule
• It is very sensitive to small, persistent errors that commonly occur in the modern,
low calibration- frequency analyzer
• Results are out of control when the slope exceeds 45𝑜 or a decision ( __
+
2.7 SD) is
exceeded
Youden /Twin Plot
• It is used to compare result obtained on a high and low control serum from
different laboratories
• It displays the results of the analyses by plotting the mean values for one
specimen on the ordinate (y-axis) and the other specimen on the abscissa
(x-axis)
• The points falling from a center but on the 45𝑜 line suggest a constant error.
Youden /Twin Plot
Shewhart's Levey-Jennings Chart
• Trend: is formed by control values that either increase or decrease for six
consecutive days
main cause: deterioration of reagents, deterioration of light source,
deterioration of control materials
-indicates gradual loss of reability in the test system.
TREND (LJ CHART)
SHIFT(LJ CHART)
OUTLIERS (LJ CHART)
Errors which can be observed on Levey-
Jennings chart:
1. Time
2 . Patient outcomes
3. Personnel efforts
“ When making measurements there is always some level of inaccuracy the
challenge is to reduce the level of inaccuracy as much as possible giving
limitation of our testing system “
LABORATORY ERROR
1. Organizations
- In order to have a functioning quality management system, the structure
and management laboratory must be organized so that quality policies can
be established and implemented
- There must be strong supporting organizational structure that is
management commitment and there must be a mechanisms of
implementation monitoring
QUALITY SYSTEM ESSENTIALS
2.Personnel
- Human resources - Continuing Education
- Orientation - Job description
- Professional development
- Job qualification
- Training
- Competency assessment
QUALITY SYSTEM ESSENTIALS
3. Equipment “Many kind of equipment are used
- Acquisition - Record in the laboratory that is important
to note. Each piece of equipment
- Instillation
must be functioning properly ,
- Calibration choosing the right equipment ,
- Troubleshooting installing is correctly , assuring that
equipment works properly and
- Validation having existing maintenance of all
- Maintenance part of equipment “
- Repair and service
QUALITY SYSTEM ESSENTIALS
“ The management of reagents and
supplies in the laboratory is often a
4. Purchasing and Inventory challenging task, however proper
management of purchasing and
- Vendor qualification inventory can produce cost saving in
addition to assurance of supplies and
- Supplies and reagents
reagents that is available when needed
- Critical services the procedures that a path of
management purchasing and inventory
- Contract review
are designed to assure that all reagents
- Inventory management and supplies are all good quality and
used and stored in a manner that
preserves integrity and reability “
Purchasing and Inventory
• Scenario:
Your laboratory is asked to gear up for a potential flu epidemic
-What purchasing and inventory factors do you need to consider in planning for this
process ?
-What problems might you encounter in planning and implementing?
• Purchasing considerations :
Purchasing and Inventory
• Analyze needs:
Conduct analysis of supply and reagent needs by:
1. Listing all test in laboratory
2. Identifying all supplies needed for each test
3. Using available information to estimate usage
Purchasing and Inventory
• Quantification: When?
- As a part of annual health care planning
- When implementing a new health program
- In preparation for potential or newly identified epidemic
Purchasing and Inventory
• Quantification : How?
1. Consumption-based method
2. Morbidity-based method
Purchasing and Inventory
• Consumption-based method
- Based on the actual usage
- Must take into account:
1.health supplies actually used
2.wastage-expired or spoiled supplies
3. supplies out of stock for more than 15 days during any time of the year
Purchasing and Inventory
• Morbidity-based method
Must take into account:
1. Population size
2. Disease incidence
3. Accuracy of morbidity data
4. Treatment guidelines
Purchasing and Inventory
• Stock logbook
Includes:
Name and signature Stock balance
Date or receipt
Quantity Other information :
Date of expiry Shelf number
Minimum stick destination
QUALITY SYSTEM ESSENTIALS
5. Process Control
-Quality Control
-Sample Management ( specimen handling and collection)
-Method Validation
- Method Verification
PROCESS CONTROL
(SAMPLE MANAGEMENT)
SCENARIO 1: Laboratory has performed PCR for influenza virus patient
samples from Clinic A. Most of these results are negative. The medical staff
from clinical staff of influenza.
My question is what are you going to check? , what will you do?
Answer:
First, we have to investigate from where the problem exist in path of workflow
prior to actions.
PROCESS CONTROL
(SAMPLE MANAGEMENT)
“So lets start with sample management which includes sample collection and
handling “
“I JUST WANT TO EMPHASIZE THAT THE RESULT OF ANY LABORATORY
EXAMINATION IS ONLY AS GOOD AS THE SAMPLE RECEIVED OR COLLECT
IN THE LABORATORY”
PROCESS CONTROL
(SAMPLE MANAGEMENT)
• Pre-examination Steps
- Verify : completeness of test request, appropriateness of sample,
information on label
- Record in REGISTER LOG
- Enforce sample rejection criteria
Example: spilled urine sample a cause of rejection
PROCESS CONTROL
(SAMPLE MANAGEMENT)
• Actions for Rejected Samples:
1. Inform authorized person
2. Request another sample
3. Record rejected sample
4. Retain rejected sample based on present criteria
5. Extraordinary circumstances may require testing suboptimal samples
PROCESS CONTROL
(SAMPLE MANAGEMENT)
• Sample REGISTER LOG
A register should include:
1. Date and time of collection
2. Date and time of receipt
3. Sample type
4. Patient name
5. Demographics as required
6. Laboratory assigned identification
7. Test t0 be performed
PROCESS CONTROL
(SAMPLE MANAGEMENT)
• Sample disposal:
-Set of policy for sample disposal
- Compliance with local and country regulations
- Disinfection procedures
PROCESS CONTROL
(SAMPLE MANAGEMENT)
• Sample transport:
- Maintain integrity of sample
1. Temperature
2. Preservations of sample
3. Special transport containers
4. time limitation
QUALITY SYSTEM ESSENTIALS
• Documents vs Records:
Documents: Communicate information via policies, processes, and procedures
- need updating
Records: Capture information on worksheets, forms, labels, and charts
- permanent , do not change
Documents and Records
• Hierarchy of documents:
1. Procedures
2. Processes
3. Policies
Documents and Records
What is “occurrence”?
Any event that has a negative impact on an organization, which includes
personnel , product equipment or environment.
Occurrence Management
Scenario :
There was an important job in the laboratory that needs to be done and everybody was asked
to do it.
Everybody was sure SOMEBODY would do it
Anybody could have done it, but Nobody did it.
Somebody got angry about that because it was Everybody’s job. Everybody thought Anybody
could do it .
It ended that Everybody blamed Somebody when Nobody did what Anybody could have done
Occurrence Management
Another classification or error and mistakes is based on the time and the stage they
appeared in laboratory practice.
1. The pre-analytical stage encompasses all the procedures which a take place
before the analysis of the patients sample(e.g. blood drawing , sample
transportation , centrifugation)
2. The analytical stage includes the analytical method
3. The post-analytical stage refers to transmission of data from analyzers to the LIS ,
validation of results that have been produced and posting of the results to
physician or patients.
Occurrence Management
• Pre-examination error
Example include:
1. Wrong sample collected
2. Sample mislabeled or unlabeled
3. Sample stored inappropriately before testing
4. Sample transported inappropriately
5. Reagents or test kits damaged by improper storage
Occurrence Management
• Examination error:
-established procedure not followed
-incorrect timing of the test
- Results reported when control results out of range
- Improper dilution and pipetting of sample or reagents
- Reagents stored inappropriately or used after expiration date
Occurrence Management
• Investigation of error:
Root cause analysis:
Structured investigations that focus on identifying the underlying true causes
of occurences
- Every cause has deeper reason
- For each occurrence seek 5 levels of explanation , asking WHY , before being
satisfied as to the (root) cause
Occurrence Management
• Investigation of error:
Example of Root Cause Analysis:
Occurrence Management
(Example: erroneous result ----> immediate notify all persons concerned ---
----> provide correct results)
Occurrence Management
Rectifying and Managing Occurrence :
3. Corrective actions: “Learn from the event and avoid its accurence”
Corrective actions: addresses the cause of error. If the test was not done
correctly, resulting in an incorrect result, corrective actions sort out why the
test was not performed properly, and steps are taken so that the error does
not happen again.
Example: Malfunctioning Equipment -> Recalibrate , Repair
Occurrence Management