CHAPTER

9
Quality Control Management

Quality control
- the sum of all those activities in which the laboratory is engaged to ensure that the
information generated is correct.
- It includes all aspects of lab activities that affect results such as the choice of methods,
education or personnel, handling of specimen and reporting of results
- Quality control programs vary with the product, available expertise, and the limitation of
resources. In the case of hospital laboratories, the product is test data; standards of
quality include timeliness of performance, accuracy of results, and effectiveness of
communication.
- Establishing and maintaining of good program may sound expensive, but it pays off in
terms of efficiency, higher staff morale and productivity and greater patient acceptance

Lab practices on quality control can be divided into 3 major divisions:
1. Preventive – are those activities done prior to the examination of specimen or sample and
are intended to establish systems conducive to accuracy in analytic systems such as
preventive maintenance and calibration of instruments, testing of media, orientation and
training of personnel.
2. Assessment – are those activities done during the testing to determine whether the test
systems are performing correctly such as the use of standards and controls and
maintenance of control charts.
3. Corrective – are those activities done when error or possible error is detected to correct
the system such as equipment trouble shooting, recalibration of instruments, etc.
* Numbers 1 & 2 are more emphasized because the information must be timely to be useful

Control of tests
Selection of tests should be based on four factors:
1. The result produced should be useful in a time-reference frame.
2. The procedure should be feasible for the particular laboratory.
3. The value produced should be accepted to clinicians
4. The reports forwarded to clinicians should be uniform. A good report should be compact,
consistent in terminology and format.

The assessment factor for method evaluation and selection
1. Precision – maybe defined as the extent to which measurements are repeated. The
assessment is made by replicate analysis of a biological control containing stable and
measurable amounts of the appropriate constituents(s) and expressed as the magnitude
of error in the method.
2. Accuracy – maybe defined as the extent to which measurement approach the “true”
quantity of the constituent being analyzed. Measurement must be conducted on a
reference material having a known composition and concentration.
3. Sensitivity – maybe defined as either
- the extent to which the minimum amount of constituent can be measured of
- the reliability of a test to be positive in the presence of the disease it was design to
detect
4. Specificity - maybe defined as either
- the extent to which measurements are those of single constituent or
- the reliability of a test to be negative in the absence of a disease it was design to detect.




 Control of Specimen
Collection of proper specimens is extremely important. Those involved in blood
collection know the proper way to collect a specimen and the correct details concerning
name of tests, containers and labels, time delivery, preparation of patients, preservation or
anticoagulant, handling or storage of specimen before
delivery to lab and special instruction.
A good way to assure proper specimen is the distribution of specimen collection
manual to those involved in collection.

Control of reagents and supplies
Reagent should be purchased only from reliable suppliers. But only the quantity you use in a
reasonable time, date it upon receipt and again when opened for use.
Guidelines in the use of reagent kits:
1. It should give consistent results form day to day and in patient samples with low, normal
and elevated values.
2. The manufacturer’s data must be complete: statement of principle, description or test
performance and calculation, data on precision, accuracy and stability of reagents.
3. Cheaper than manual methods
4. Every employee should be competent to use the kit.
5. The reliability of reagents and materials can never be taken for granted, and they must
periodically verified to be without contamination or deterioration.
6. In the microbiology laboratory and blood bank where testing is largely the identification of
unknowns (qualitative), frequent assessment of reagents and material quality provide the
only means of assuring reliable test results.
7. In the clinical chemistry and hematology laboratories, where testing is largely quantitative
of specifically requested constituents, biological controls containing the same constituents
provide an alternative one step-method for assuring total integrity of test performance.
Control of equipments
There is usually some variation in the performance of equipment. The error can be exaggerated
if the equipment is improperly calibrated of malfunctioning.
Suggestions in the control of equipment:
1. Use National Bureau of Standard equivalent thermometers for monitoring water baths,
heating blocks, incubators, refrigerators and similar equipment.
2. Verify the reliability of analytical balances and weights by inspection using National
Bureau of Standards class S weights.
3. Verify the speed of centrifuges regularly using quality tachometer.
4. Check all water used in testing for its pH, purity and any foreign substance that could
affect test results.
Control of Staff
The work of any laboratory can be as good as the quality of its workers. Therefore, the
laboratory should seek to attract and keep only the best employees. Three important ingredients
are:
1. Maintaining an atmosphere of professional challenge
2. Offering fair wages
3. Providing a means for obtaining continuing education
* To be sure the staff is working at maximum efficiency- neither underutilized nor overworked – a
system of workload reporting is necessary

Non-analytical quality control functions
1. Physician request – all requests made by the attending physician should be stated clearly.
2. Request specification
a. time specifications:
- routine – response for test requests within 24 hours, but may take longer for
some procedures as culture
 - today – response and test results within 8 hours
- stat – response within 10 min, no delay in test performance
- specific time – specimen collection within +/-5 min time designated, no delay in
test performance
b. condition specifications: pre-op, pre-admissions, etc.
c. patient category specifications: “in-patient”, “out-patient” etc.
3. Worksheets – they are used most commonly for recording test results and other informative
data not usually reported. The are particularly well suited to most hospital chemistry and
hematology laboratories.
4. Patient identification – the customary practice is to attach identification band to all patients.
The exact matching of all patient information appearing on the request with that on the bracelet
should be done.
5. Distribution of test results – in most instances, the recipients of the laboratory data include:
a. nursing station personnel (patient chart attachment)
b. hospital business office (patient bills)
c. attending physician (personnel use)
d. laboratory clerical section (department record)
6. Specimen reassignments – reassigning specimens to a reference laboratory is considered
only after the capabilities and cost of in-house performance are determined. Factors to
be considered in the selection of reference laboratories:
6.a. range of available services (brochure listing)
b. quality (staff, facilities, etc)
c. location (transportation mode)
d. turn-around-time (periodic review)
e. fee schedule (comparison with laboratories of comparable structure)


Quality control charts
Control charts assist in monitoring avoidable and unavoidable error. The usual format
includes an ordinate for entering the range of values over which the control results are
most likely to occur and abscissa for recording the time intervals at which the control
results are obtained. A pair of horizontal lines are included to correspond with the
permitted limits (values) of unavoidable error
Quality control charts are used in:
1. Identifying the sporadic errors that are generally caused by the analyst – control values
falling out of acceptable range are rejected as avoidable errors that must be identified and
corrected. All unknown tests belonging to this batch are repeated. In the absence of
avoidable error, 95% of analysis should be within control values.
2. Determining subtle problems manifested by trends and shifts – a trend occurs when
control values continue to increase or decrease over consecutive days, suggesting reagent
or equipment alterations. A shift is formed by control values that maintain a constant
level on one side of the mean line, suggesting an incorrecty prepared reagent.

Proficiency testing
The major thrust or proficiency testing is to improve the quality of laboratory services by
setting forth standards of performance that must be met or exceeded.

A reference laboratory is one of the recognized competence, which examines in detail proficiency
testing samples or other materials to authenticate identification, content or titer.
The laboratory is specially qualified by experience, interest and accepted expertise.
The analysis are done carefully and are performed in replicate.
The mean test results values are considered to approach “true values” and serve as a
measurement of the accuracy of test results obtained by the participating laboratories.

 A reference laboratory is one recognized competence and a general participant in the proficiency
program.
It uses the same time schedule and performs the examination under the same condition
as all other general participants.
The identity of these laboratories is not revealed.
Their test results are used as a measure of quality of the proficiency testing specimen and
with the reference laboratories’ results, are influencing factors in deciding the acceptable
range of results.
A participating laboratory is enrolled in a proficiency program and adheres to testing all
proficiency specimens in the identical manner employed for patient testing.
Replicate analysis are avoided and duplicate assays are performed only when duplicate
testing is a laboratory routine.
Requirements for participation, frequency of specimen shipments, time allotted for
returning results and methods of grading are determined by the organization conducting
the program.


CHAPTER X
Safety Management

Laboratory safety programs are plans for preventing sickness and injury to personnel and damage or
destruction of physical assets.
The fundamental objectives of a meaningful laboratory safety program are:
1. To improve safety skills and attitude of all personnel
2. To develop a surveillance program for promptly identifying hazards
3. To formulate plans for promptly correcting all hazards
4. To coordinate laboratory safety efforts with the over-all hospital safety program.
An employee health program must include:
1. pre-employment physical examination with laboratory and radiological studies that
establish fitness for laboratory employment
2. Periodic inspection of above in most instances reassessments are made yearly, but some
findings and/or working conditions dictate a shorter interval.
3. Written reports of all work-related illnesses and accidents with review by director or
designee
4. Employee health records for the total period of employment.

A general safety program must include:
1. Orientation of new employees to department’s attitudes and policies for assuring safe
laboratory conduct.
2. Periodic supervisory staff meetings for the purpose of discussing safety; attention is given
to particular times and circumstances that lend themselves to deviation from policy (lack
of supervision, excessively busy work periods, etc)
3. Orderly housekeeping standards for both laboratory and housekeeping personnel.
4. Signs indicating need for special precaution in area where posted; also, strategically
placed signs, indicating general need to avoid thoughtless and reckless behavior.
5. Orderly storage and arrangement of supplies and working materials; insistence on
adequate space.
6. Policies governing eating, drinking, smoking and safe attire within the department.
7. Periodic inspections by director or designee for purposes of indicating interest and
concern for the programs.
8. Consideration of periodic programs by outside persons with expertise in special areas of
laboratory safety.
9. Consideration of hiring a full or part-time safety officer
10. Coordinated efforts with hospital for assuring isolation of communicable diseases, control
of nosocomial infections, and plans for dealing with fire and disaster.

Hazards in the laboratory
1. Fire hazards – fires can be divided into four important classes designated as classes A, B,
C, and D
a. Class A fire – this is a fire of ordinary combustibles, for example, paper, cloth,
wood, trash, etc. This kind of fire maybe put out by water.
b. Class B fire - this is a fire of flammable liquids, for example, gasoline or organic
solvents. This kind of fire can be put out by a dry – chemicals, foam or carbon dioxide fire
extinguisher. Never use water for such fire.
c. Class C fire – this is an electric fire, for example, motor, wiring etc. Only dry –
chemical or CO2 type fire extinguisher should be used. Water should not be used for third
type of fire.
d. Class D fire – this a fire of combustible metals, certain chips, shavings, turnings
etc. This kind of fire maybe extinguished by the dry-power type extinguisher, sand or
NaCl.
* A useful monitor for fire hazards is the smoke detector. It gives the earliest warning of
fire

2. Chemical hazards – the danger which are associated with chemicals arise from their
toxicity and hazards due to burns, fire and explosions. There are two types of chemical
hazards:
a. external – this is the result of caustic or corrosive substance like acids, bases,
strong salts, and silver nitrate. Precautions should be taken to prevent accidents like
splashes and container spills.
b. Internal – this is the result of the toxicity of substances. Benzidine, o-
dianisidine, o-toluidine are known to induce cancer of the bladder in man some years
after the first exposure.
3. Radiation hazards – the sources of radiation in the laboratory
a. radioactive isotopes – the use of radioactive isotopes is becoming widespread
with the development of radio immunoassays.
b. x-rays – the hazards from x-ray come primarily from special instrument such as
x-ray diffraction apparatus
c. ultraviolet sources – the danger from UV arise from the lack of proper shield and
from human carelessness. UV irradiation can easily be controlled because of its shallow
penetration of solid materials including glasses. UV lamps us be turned off immediately
after use (to control microorganisms and to sterilize objects) to avoid over exposure.
Biological hazards – the source of danger from biological sources (CSF, urine, blood etc) is
that they may harbour pathogens that can be transmitted by various routes to the
laboratory staff receiving, processing and disposing them.
5. Mechanical or physical hazards – these hazards are associated with structural or
mechanical defects as slippery floors, projections that cause cuts and bruises like nails,
inadequate lighting, machinery with unprotected moving parts, etc.
6. Electrical hazards – these hazards are attributed to improper grounding. Inadequate
wiring and improper insulation of equipment.
7. Thermal hazards – laboratories have fire hazards because of the flames, heating devices
and electrical equipments. Contact burns of individuals with hot equipments as heater
and autoclaves are common problems.
8. Explosions and implosions – the hazards from explosions are always potential when
explosive chemicals particularly compressed gasses are used in the lab with electrical and
heating equipment.
 9. Noise – it has as effect on the quality of the performance through fatigue and distraction.
Sudden unexpected noise may produce deleterious effects during critical manual
procedures
10. Cryogenic hazards – these are due to freezing and handling cold materials such as dry ice.

Safety equipments in the laboratory
1. Fire extinguisher – these are of three general types
a. water type which is useful for fires of ordinary combustibles as wood, paper,
rugs, etc.
b. dry chemical type which is effective against most fires but particularly those
involving flammable liquids, metals, and electric fires.
c. carbon dioxide type which is useful for small fire due to flammable liquids.
2. Safety showers – these must be conveniently located for use in accidents involving acids,
caustics and harmful liquids, clothing, fires, etc.
3. Eye washes – these must be available to promptly flash the eyes in care of accidents.
4. Safety shields – these protect workers from several type of potential accidents such as
exposure to various forms of radiation like laser beams. Safety shields should be made of
material that is shatter proof, fire retardant and able to filter out harmful radiations. One
important type of safety shield is a chemical hood.

Personnel protective equipments and materials
1. Clothing – employee involved in using radioactive materials, suspected carcinogen and
pathogenic materials may be required to wear lab clothing when entering the workroom
and change when they leave.
2. Gloves – rubber gloves are used when handling hazardous liquids; lead gloves when
handling radioactive materials; surgical gloves when handling pathogens; insulated gloves
when handling hot and cold objects; heavy leather gloves when handling certain animals.
3. Safety shoes – they are required in the lab where heavy objects and equipments must be
moved
4. Hard helmet – they are required when there is overhead machinery in the lab.
5. Safety eye glasses – personnel should be required to wear safety glasses to protect
themselves from splashes, powder, UV exposure, flying objects.
6. Respirators – these should be available in emergency situations where dangerous gases,
like boron, dry fluoride, dimethyl amino, ethylene oxide, hydrogen bromide are used or
produced.
7. Face masks – these are used by personnel handling animal infected with pathogenic
airborne organisms.

Programs for handling chemicals
1. Prescribed containers and adequate storage space with secure shelving and proper
ventilation.
2. Permanent container labels with clear identification of contents; bold identification of
particularly harmful chemicals.
3. Policies for transporting containers, particularly if large, heavy or filled with especially
dangerous contents.
4. Instruction for dispensing, transfering and disposing of all chemicals.

Program for handling biological materials
1. Instruction for collecting transferring, storing and disposing of all specimens.
2. Policies for isolating test procedures performed on specimen suspected to contain
infectious agents.
3. Instructions for washing and the care and cleaning of work surfaces.
4. Instructions for cleaning and / or disposing of specimen collection equipment.

 Fire prevention program
1. Physical facilities and operational practices that satisfy fire code.
2. Instructions for handling and storing combustibles; container labels with “flash points”.
3. Instructions for operating all heat-generating equipment (gas burners, hot plates, etc)
4. Well-conceived and rehearsal plans in event of fire that are closely coordinated with
hospital efforts and include strategically placed and properly maintained san bucks, fire
extinguishers and fire blankets

Safety codes
Safety codes are aimed to serve in a form of a poster and placed in strategic point in a
laboratory so as to serve as a reminder to laboratory workers to be safety conscious at all
times.
1. Use proper techniques.
2. Use safety devices and protective clothing where necessary.
3. do not smoke, eat, drink, bite nails or pencils or apply cosmetics in the laboratory.
4. Assume that ever chemical and biological material is dangerous unless there is definite
information to the contrary.
5. Do not pipet with mouth
6. Fooling around should never be permitted in the laboratory
7. Hands should be washed as often as needed.
8. Be tidy, clean up spillage immediately
9. Keep hands dry to avoid shocks from contact with faculty electrical switches, plugs and
writing.
10. Turn off burners when not in immediate use
11. Do not work alone in the laboratory, a second person should be within call.






Chapter XI
Financial management

Financial management
- involves planning the procurement and utilization of funds and controlling the financial
operation to assure effective utilization of funds. “funds” is often used to money or cash.
Financial planning – is concerned with the setting of financial goals, the determination of future financial
requirements and the possible sources of funds which should be available at the least cost when
needed. The tool of management in financial planning is the budget.
Budget - is a systematic programming of organizational activities based on their costs and on the
amount of resources available.
2 kinds of budget:
a. master budget which is prepared into anticipated income and expenses.
b. detailed budget which is prepared for the various units in the organization.

How to prepare a budget
The budget should be divided into anticipated income and expenses.
Income can be projected on the basis of patient days, services rendered per patient day and the
charges that may be made for these services.
Expenses involve personnel costs which amounts to about 70% of total expenses;
Overhead costs usually include interest on indebtedness, utilities, phone, building maintenance and
various other costs that can not be allocated to a specific areas.
 Personnel costs are defined in larger part by the salaries of permanent employees who are already
working at the start of the fiscal year. Additional personnel may be anticipated (or reductions
may be planned) and the adjustments must be made for their impact.
Supplies can be estimated on the basis of previous experience. If new equipment is anticipated, and
changes made in supplies, etc., these can be figured into totals already established.

Chart of accounts
1. Salaries
a. exempt
b. non-exempt
2. Supplies
3. Equipment
a. purchase
b. rental
c. lease
d. maintenance
e. depreciation
4. Reference laboratory fees
5. Continuing education travel
6. Subscription and dues
7. Hospital administrative assistance
8. Telephone
9. Housekeeping
10. General maintenance
11. Electricity
12. Building depreciation
13. Taxes
a. payroll
b. sales
14. Insurance
a. general liability
b. workman’s compensation
c. group health
d. others
15. Miscellaneous
Laboratory budgeting is an ongoing process that culminates annually with the expense projections for
the coming year. The forecasts are made in accordance with the chart of accounts and are
divided into quarters. These three-month intervals represent the best times for expenditure
modification.
Tools for fiscal decision making
1. Laboratory workload reporting
2. Cost finding

Laboratory workload reporting
Workload unit is defined as one minute of technical, clerical and aide time.
In an ideal situations, there should be productivity of 60 workload units (that is 60 min of
productive work) for each hour of worked time.
- The closer the workload units per hour is 60, the nearer it would seem that the laboratory is to
operating at 100% efficiency.
- In actual practice, the average workload productivity in most laboratories is in the range of 30 to
55 workload units per hour.
CAP workload unit = 1 minute of technical, clerical and aide time




Productivity (units/hr) = total workload units
----------------------
hours

The more highly automated disciplines, chemistry and hematology report the highest ratios.
The productivity units is of great value in comparing current with previous productivity in comparing
sections within the laboratory and comparing laboratories with other comparable laboratories.
If a laboratory’s productivity consistently runs over 60, then the laboratory maybe understaffed and
need additional personnel support. Laboratories are encouraged to use this tool since it provides useful
information for budget forecasting and determining future staffing levels.



Cost finding
– is a means by which a laboratory documents its cost for performing a particular procedure and
then establishes its charges on the involved direct and indirect cost.
- should be done by laboratory personnel in consultation with the fiscal staff of the hospital. This
combination is necessary since the laboratory staff can analyze steps involved in performing
procedures while fiscal personnel are needed to provide the indirect (or overhead) expense and
to assist in preparing the data for submission to the hospital administration, board of trustees
and third party payer, for approval.

1. Direct vs indirect costs
two general types of costs are involved n the operation of a laboratory in costing any single
procedures:
a. direct costs
b. indirect costs
Direct costs – are costs of materials supplies and personnel time directly attributed to specific
measurements or examinations
- such costs include allocated portion of utilities, laboratory and institutional administrative
expenses, building depreciation and janitorial services.
2. Fixed vs variable cost
The concept of fixed and variable costs is useful in analyzing the effects of changing volumes of
determination or expense and revenue.
A. fixed costs in a laboratory are constant overtime regardless of volume of determinations,
Depreciations, supervisor salaries and rental charges are examples. The laboratory will incur
these charges at a fixed rate that should vary with reasonable charges in work volumes.
B. variable costs are those costs (for items such as supplies and reagents) which will vary in a
relationship to the volume of determinations.
Fixed costs are much larger than variable costs since personnel costs usually account for 60 to
70% of the total budget of most hospitals.
In general, therefore, the greater the workload performed by the laboratory, the less per unit
cost. Decreases in per unit cost, however are eventually limited regardless of further increase in
volume because of the necessity for incremental additions of personnel and/or equipment.








 Chapter XII
Decision Making


The problem – is defined in many ways. It may be defined as a deviation or an imbalance between
what “should be” and what “actually is” happening. This imbalance is caused by change of one
kind or another.
A problem could be answered by the question, “what is wrong that needs correction”.

2 distinctly different categories of a problem
1. Causality-based problems
They have well defined boundaries. Their elements are connected primarily through
cause and effect.Thus it is fairly clear which elements are part of the problem and which are
not. Moreover, these elements are related to one another logically: you can see a linear
relationship between them.
For example, the laboratory intercom’s failure to work properly is a causality-based
problem. The boundaries are well-defined: buttons, wire and telephones are “in” the
situation; the spectrophotometer, the autoclave are not. These elements also are linked by
cause and effect. The intercom’s buttons “cause” the telephone to ring or not to ring.
2. meaning-based problems
The boundaries are poorly defined.
It is not obvious which elements are contributing to the problem and which are not.
The elements in the meaning-based situation rarely are linked directly by cause and effect.
Instead, the nature of their connections depends on the meaning attached to each
elements.
For example, the financial proceeds of the laboratory is declining. Which elements are in
and which are not? The facilities, the personnel, the scope of activity, the trend, etc are
“in”. In meaning based situations, the elements to include are not given, they must be
chosen.
Participative or unilateral problem solving
As problem solving is the first stage of effective decision making, managers begin by
determining whether group participation in problem solving is desirable. Two questions are
critical to this decision:
1. Will acceptance or rejection of the solution by any of the employees involved in
implementing the solution make a difference in how well it is implemented?
If the worker acceptance is not an issue, there is no need to use participative problem
solving.
If, however, employee acceptance and commitment are critical, then it is important that
employees be involved so they can have influence or control over the final solution.
2. Does the quality of the solution make the difference? When quality matters a little, but
employee acceptance is important, group problem solving is helpful.
If, however quality is important but acceptance is not, a manager may choose to make the
decision alone or request input from and individual with specific expertise or experience in
the subject matter
but if the answer to both question is yes, then participative group problem solving is
important.
Participative Problem Solving:
- employers allow or encourage employees to share or participate in organizational decision-
making
Unilateral Problem Solving
- a manager may choose to make the decision alone or request input from and individual with
specific expertise or experience in the subject matter


Seven steps of problem solving
Scientifically oriented managers should find it easy to learn how to solve problems and make
decisions, since the analytical problem solving skills they learned as clinical laboratory
scientists are the basis for managerial decision making. The classical scientific method of
problem solving involves the ff basic steps:
1. Find the problem
2. Diagnose the problem
3. Develop alternative solutions
4. Evaluate alternative solutions
5. Select the best solution – the decision point
6. Implement the solution after developing a plan
7. Evaluate feedback and take corrective action where needed to ensure the problem is
solved.
* A full appreciation of the process requires in-depth analysis of the seven components

Find the problem
Most managers have little difficulty in finding problem. Failure to meet objectives,
decreased production or quality of service, lowered employee morale, diminishing income,
and a rise in incident reports are all problems easily identified by managers.
Employees, peers and supervisors are also a source for finding problems
A manager need only be alert to the existence of problems and prepared to investigate their
causes.
It is important, however, to be sure you do indeed have a problem, something that is based
on fact, and not the result of opinion, misinterpretation, or bias. To avoid “jumping into”
every apparent problem that comes along, investigate to determine if it is indeed a problem
deserving of our time and attention.
Diagnose the problem
Diagnosing the problem is the most important step in the problem solving process. If the
wrong problem is identified, or a symptom rather than the problem selected, then the
solution will not be correct.
To assure a good diagnosis you should:
1. Define the problem in writing as briefly and accurately as possible
2. Gather as much data as possible to determine the cause/s
3. Identify the specific cause to reduce work latter on
4. Identify known constraints and barriers that would preclude some solutions
* Care should be taken to not become bogged down by excessive attention to gathering more than
enough information.
You can never have enough information, so the data-gathering effort should be consistent with the
potential effect of the decision that must be made. And when gathering information, it is
important to work with facts, not opinions.

Develop alternative solutions
Once the problem has been defined and the causes identified, develop as many solutions as
possible. This step requires creativity and imagination. and it is a this portion that
employees will have their most active involvement.
A brain storming approach works very well to develop a list of possible solutions. The
important part of this step is that as many solutions as possible should be identified, but
none of them should be evaluated.
Criticizing the suggestions tend to inhibit contributions, one of which could possibly be the
basis of the best solution.
Evaluate alternative solution
At this stage, the final list of feasible alternatives is evaluated.
In addition to a direct look at the pros and cons, cost-benefit analysis may be appropriate.
 If the financial aspect can be quantified, and the patient benefits verified, selection of the
most effective alternative will be fairly easy.
If either or both the costs and benefits are intangible and cannot be accurately quantified,
then estimates can be used to provide same reference point. This often occurs with people
problems.
Select the best solution
this is the final decision-making point and their performance determined how decisive
managers will be. Careful consideration must be given as to how the decision is to be
made.
4 major types of decisions:
1. Considered decision – are those that have a major effect on the total operation. They are
complicated and require considerable reflection. They require much interaction with
others to find alternatives, to seek other opinions, to get dissent, and to project
implementation problems.
2. Operational decisions – are the routine kinds of things we do on day to day basis. These
kinds of decision give employees an excellent opportunity to develop as decision makers.
3. Swallow hard decisions - are the kind that are often personally uncomfortable. They
usually deal with interpersonal relationships and must be decided by the managers. The
key to their acceptance is full explanation of he rationale. Employees may not like the
decision but they can understand why it was made.
4. Ten-second decisions – are dictated by external pressure. They may involve nothing more
than an employee requesting an hour off that day. Since ten- second decisions are
primarily unilateral decisions, managers must remember that the will be held accountable
for the decision.
Implement the solution
At this stage, a plan must be developed that includes designation of required personnel,
list of available financial and material resources and assignment of authority,
responsibility and accountability.
Another critical part of this stage is gaining employee acceptance if they have not been
involved in the preceding stages. The best decisions are of no use unless they work. And,
they will work only if the people involved have a mind to make them work.
Evaluate feedback
- Take corrective action
- Things change, and today’s good decision may become tomorrow’s problems. Needs and
references change as do people, products and the environment. Priorities are adjusted
and situations require new action plans. It is the manager’s responsibility to stay on the
top of the situation, either through periodic progress reports or personal follow- up.

Defining “indecisive manager”
Indecisive manager exhibits one or more of the 5 symptoms:
1. Imitation – employees, often unconsciously, tend to imitate their bosses. So, they will
most likely make decisions as the boss did or would want it done.
2. No plans – if the manager simply responds to crises and set no objectives, he is not
making decisions, merely reacting to situations.
3. Not enough information- data is important but indecisive manager always seem to want
more before the can make decision.
4. Fear or risks - indecisive managers when forced into making a decision, want no record
kept nor do the want people following up to see how the did.
5. Excessive use of committees – using participative management as an excuse rather than a
positive management tool, the indecisive manager hides behind this by continually
putting off the decision. But, delay usually makes the problem worse and requires further
decision making.


 Case study
A case study contains a variety of issues or problems from the trivial to the significant, from the
irrelevant to the relevant.
Format for case analysis:
I. Case title:
II. Viewpoint:
III. Problem: (specify what the problem is by describing it very accurately)
IV. Objectives: (they are statements of functions to be performed or fulfilled by the course of
action)
V. Areas of consideration: (they are explicit and implicit facts around the possible causes of
the central problems)
VI. Alternative courses of action: (they are collections of the best ways of meeting the
individual objectives. The strengths and weaknesses of the alternatives must be
appraised)
VII. Final decisions: ( a final choice must be made which seems best for the problem. In
action, or status quo, is no decision at all)
VIII. Detailed plan of actions: (this is done to ensure the success of the decision or
recommendation)

Chapter XIII
Laboratory liability

Injury liability of the laboratory
Most lawsuits alleging malpractice involve some form of patient injury. Most injuries arise as
direct complications of laboratory practices and procedures. Aside from the usual meaning,
injury includes:
1. The continuation of the patient’s original disease process because of a delay in diagnosis
(perhaps induced by a laboratory error), and
2. The performance of unnecessary therapeutic procedures as a result of a misdiagnosis of
the patient’s condition (perhaps caused by laboratory error)
Laboratories may be liable for indirect injuries to patients they have never seen. The laboratory-
patient relationship is established, in these instances, when specimens are received for
examination or analysis.
Laboratories are sued less frequently than practicing physicians. The procedures laboratories
perform on patients, while processing some risk of injury, are less apt to cause major
calamities. Injuries caused directly by laboratory activities, therefore, are less frequent and
less severe, procedure by procedure, than those caused directly by attending physicians and
surgeons.
Laboratories can cause injuries indirectly by producing incorrect test results upon which the attending
physicians may rely to their patients’ detriment. However, before a laboratory can be held
liable for causing this type of injury, someone has to produce evidence that the physician had
the right to rely upon the incorrect laboratory report. Though the physician’s “right to rely”
depends upon the facts of each individual case, the existence of this intermediate issue of
reliance constitutes a form of insulation against malpractice liability for laboratories.
Injuries caused directly by the laboratory
1. Extraction of the specimen
Venipuncture constitutes the most likely source of potential injury. This involves multiple,
unsuccessful attempts to obtain venous blood specimens, usually by inexperienced medical
technologists.
Though it is capable of inducing many different types of complications, real injury rarely
occurs; therefore, venipuncture per se is not a significant source of liability for laboratories.
Arterial puncture possess a greater risk of injury, demanding considerable expertise on the
part of the technologist, as well as adequate follow-up evaluation of the patients’ extremely
to assure continued arterial sufficiency.

The advent of medical standards requiring increased use of blood-gas determinations will
probably precipitate a number of arterial injuries for which lawsuits will allege improper
performance of extraction technique.
Some laboratories perform spinal tap (lumbar puncture) to obtain CSF specimen for
requested examinations. If performed by pathologist who possess limited expertise, nerve
root injury or back pains which persists for quite a while may happen.
2. Protection of the patients
Fainting associated with venipuncture is common, that patients deserve some form of
protection. Ideally, if the patient is not recumbent during and shortly after extraction, he
should be given three-sided support in a proper chair.
Having a patient sit on a stool without such support invites potential liability should he faint,
fall and hurt himself.
Some patients have known fainting tendencies. Each patient should be questioned routinely
so that increased precautions can be undertaken when indicated.
For every patient, a record can be made of the fact that a question about fainting tendencies
was asked and answered (ex., the request form can be stamped by the medical technologist
in the following manner: “denies fainting tendency.”
3. Injecting foreign substances for test purposes
Laboratories are frequently asked to perform tests on patients requiring the injection of
foreign substances, such as, bromsulphalein (BSP).
This substance is capable of inducing both systematic reactions and serious local tissue
destruction (when it infiltrates into extravenous tissues).
4. Consent
Consent is a problem for laboratories only when there is a direct contact with the patient,
accompanied by the possibility of inducing a direct injury. More often than not, this particular
problem involves minors.
When BSP is to be injected, the patient can be told about the possibility of allergic reactions
with emphasis on the necessity for the patient to inform the technologist or the physician
about specific symptoms which may develop during or shortly after the injection.
5. Misidentification of patient
Whether in the hospital or in an outpatient setting verbal identification of patient alone is not
enough.
Inpatients should be identified by wrist band. Outpatients must be identified by driver’s
license or other written document containing the name of the patient.
The most common injury associated with misidentification is administering a blood
transfusion to the wrong patient.
This is most likely to occur to inpatients where the responsibility for administering the
transfusion rests more with the hospital personnel than with medical technologists.

Injuries caused indirectly by the laboratory
1. Mislabeling of reports
Episodes of mislabeling caused by laboratory personnel are rarely defensible when injury
occurs. Occasionally, mislabeling involves blood used for transfusion purposes.
If a nurse or attending physician relies upon the stated label, unaware that it is incorrect, and
administers the blood to the wrong patient, serious injury to that patient can occur and
probable liability for the laboratory will result.
2. Sloppy results
The medical technologist should enter results in the report sheet accurately and clearly. In
one case, the checkmarks under “sensitive” and “resistant” tended to cross beyond the space
where they intended to be . Due to the sloppiness of the report; the doctor administered
Kanamycin that was not properly indicated for his patient. This resulted to ototoxicity and
deafness.
3. Miscalculation
 In several cases involving hemolytic diseases of the newborn (HDN) the laboratory produced
incorrect results of serum bilirubin tests caused by miscalculation. The error induced a delay
in the performance of exchange transfusion of the infant, resulting in brain damage from
kernicterus.
4. Improper performance of test procedure
Automation has reduced potential error in this area as well. However, there are still a
number of procedures that have not yet been automated. For instance, special procedures in
toxicology are frequently performed by hand, requiring close observation of technique and
the quantity of reagents.
5. Lost specimen
Busy laboratories sometimes lose specimens. Fortunately, most specimens can be taken
again, but the risk of liability is real.
6. Reporting the inadequate specimen
It is the duty of the laboratory to evaluate the adequacy of specimens submitted for
examination or analysis. If the specimen is considered inadequate for proper examination,
the clinician deserves a timely notice.
7. Interpretation of adequate tissue specimens
The pathologist examining tissue specimens sits in an uncomfortable position because the
specimens that he interprets are retained for posterity. If he interprets a lesion as benign and
it turns out malignant, the slides in his possession can be reviewed subsequently by another
pathologist to uncover errors.
Not infrequently, good pathologists entertain doubt about their own interpretation of specific
slides, whereupon they submit their slides to other pathologists.. Occassionally, if the count
comes back 4 to 2 in favor of cancer, the pathologist reports it to the clinician as cancer
without qualification.
If, in any manner, the spectre of laboratory error enters the picture, the practical burden
shifts to the laboratory to prove the absence of error or misconduct. Such proof might come
from two sources:
1. Records which actually trace the proper performance of the particular test involve in the
lawsuit
2. Records of adequate quality control
Since the former are rarely available, evidence of quality control becomes extremely
important. These records may be the only mechanism by which the laboratory can create
the inference it was doing as much as it could to avoid error.
Quality control, therefore, helps to avoid inferences of error as well as errors themselves.

CHAPTER IV
Computerization of the laboratory

Introduction and basic concepts of computers
Fundamentally, computers perform five basic functions: input, storage, control, processing
and output
A computer must receive data from external source. Thus the quality of function and output
of the computer cannot exceed the quality of the data given to it.
The computer must be told how to do everything it does; the art of telling is known as
programming.
A person can talk to a computer (input) by way of keypunched cards, punched paper tape,
magnetic devices, manual entry keyboards, or optical scanning devices.
The standard method of a computer talking to a person (output) is by use of typewriters,
cathode-ray tubes (CRT), punched paper tapes, punched cards, printers, and magnetic tapes.
The memory of the computer (storage) for facts and programs is the principal characteristics
which differentiates it from an electronic calculator.
 The center of every computer is the central processing unit (CPU). It contains the elements of
electronic logic which cause the executions of all actions. Instructions and data flow into it
from input points and memory devices the CPU is, in effect, the computer itself.
The two principal types of computers are analog and digital.
Analog computers make measurements on a continuous scale similar to a speedometer
Digital computers count numbers specifically and discreetly. The large majority of computers
are of digital rather than analog. A few are mixed.
In a computer system “hardware” refers to the actual physical devices such as wires, circuit,
keyboards, housing etc.
“software” on the other hand, refers to the series of orders which instruct the computer and
control it’s every operation. The logical arrangement of these instructions is called a
program.
In order to communicate with and instruct the computer, computer languages have been
developed and must be used. These computer language carry exotic names such as FORTAN,
QUICKTRAN, ALGOL, SNOBOL, COBOL, COGO and PL/1.
One of the principal personnel functions in any computer organization is programming (generation of
the instructions), which is a major skill and is quite time-consuming.

New language can be expected to be invented as new requirements are produced for
increased flexibility, in such areas as natural language processors and specialized medical
application.

The principal reasons computers are successful is their capacity to receive and store huge
volumes of data and their capacity to perform specific functions with that data rapidly.
Usually one split seconds are required to perform complicated mathematical tasks.
Also, computers make no errors, in contrast to their masters, who make many.

As data production in clinical laboratories has increased remarkably in amount, and
commonly become automated, data processing has become one of the laboratory’s biggest
problems. Mountains of laboratory data now exist for processing and utilization.

Because of the obvious applicability of computer technology, automation of data handling in
the medical laboratory appears to be inevitable. The most surprising thing is how long it is
taking for this to come about.
Data acquisition ----data management ----data reporting
A computer in the laboratory is valuable primarily because it can:
1. Sharply reduce loss of specimens from misidentification.
2. Inform the physician, at any given moment, of the status of the tests he ordered.
3. Flag abnormal results so they are not missed.
4. Double-flag critical values so they are instantly recognized and acted upon
5. Group the test results into forms that save he doctor and nurse the most time.
6. Speed up diagnosis and therapy.
7. Eliminate transcription errors expected in any manual system, usually 5 % error rate.
8. Free technically skilled lab workers from clerical tasks.
9. Eliminate test duplication.
10. Eliminate illegible results.
11. Increase quality control and assurance
12. Establish and monitor internal management controls

Considering a computer for your laboratory
If you decide to investigate computers, here are some decisions you will have to face:
1. What do you want the computer to do for you?
2. What systems are available
3. Which is best for you? (the answer may be “none”)

The ff are important points in considering a computer for you laboratory
1. Set up a meeting of key members of your staff wih selected representatives of
administration and the medical staff.
The group should include some computer-inclined technologists and others who will have
to work with any system that may be adopted.
You will probably know in advance those in your laboratory who are kindly disposed
toward new machines and new methods.
2. Get your people together and begin o brainstorm the computer idea. One helpful thing to
remember is: don’t be intimidated.
the computer world has its own specialized books and technical journals and you can
learn enough to help you make intelligent decisions.
3. Visit and talk with laboratory people who have had actual computer experience. You can
learn more hard truths his way that you’ll never hear from salesman.
4. Develop a system specification. This document defines in great detail all the
requirements for the system you visualize, including the types of printout reports and
summary sheets you want.
5. Prepare acceptance criteria. Hire experts to review bids and to choose the system best
for your laboratory.
6. Specify that the supplier will provide training manuals and a training program for our
employees.
Employees involved in planning, decision making, evaluation and training are more likely
to support and make computerization succeed
7. It is a good idea to require that all equipment be tested and function acceptably at the
vendor’s location.
Once the system comes into your laboratory, don’t pay for anything until it passes
rigorous tests on your site.
Be certain that this final testing includes a period of continuous operation of a minimum
of 80 to 120 hrs without loss of data.
8. The person who has the responsibility for a computer function must have the fullest
possible control over every element that contributes to successful operation.
Also, the computer system must be dedicated to the task at hand and must under the
control of the laboratory.
Data-management reports
The computer can be programmed to print out results in many different forms. The ff are
recommended as highly desirable for most hospital laboratories:
Reporting of laboratory results:
1. Inpatient
a. Cumulative results
list of requests and results by patient number and name, date and test, reported
daily for duration of each patient’s entire hospital stay, placed into chart by 0600.
b. Results by physician
lists of tests and results for one day for all patients of one physician, delivered to
point of his choice at 1000 and 1800.
c. Results by ward
lists of tests and results for each day, alphabeticall for patients b ward, delivered
to the ward a 1000, 1800 and 2300.
2. Outpatient
a. Results by patient
lists of requests and results daily to be filed in chart
b. Results by physicians
list of all requests and results for one day by one physician, by patient
alphabetically, delivered daily to physician.
c. Cumulative results
 status or requests for which results are not complete, upon demand.
3. Special inquiry


Laboratory operational reports
1. Master log
daily specimen accession record within each laboratory, produced daily or constantly as a
running log.
2. Test worksheet
list of all work to be completed b laboratory and by test daily, hourly, or as necessary.
3. Phlebotomy collection list
list and label by ward, room and patient name and number, for blood specimens for
requested tests, dail early A.M.
Reports to aid management
1. Summary of tests requested by lab, to predict peak volumes, produced each morning.
2. Overdue lab requests outside of specified turnaround time, periodically as necessary.
3. Critical lab volumes immediately as produced.
4. Statistical reports of quality control, trends weekly.
5. Turnaround time performance summaries by lab, weekly
6. Cumulative monthly and annual statistics in a wide variety of formats.
Clinical laboratory computerization is not comparable to the purchase of an analytical instruments;
- a successful experience typically requires detailed study and planning which include all
aspects of laboratory operation as well as interfaces with the clinical staff, nursing,
financial management, medical records, and central hospital computer system.