Management

There are many definitions for management. Generally,

management can be defined as
an ongoing process that seeks to achieve the objectives of an
organisation in the most efficient ways possible.
It may be also defined as the attainment of objectives.
It has been also simply defined as controlling and
organising an organisation and leading.
Based on the definitions we can define Medical Laboratory
Management. It is, therefore, an ongoing process that seeks
to efficiently achieve the objectives of a medical
laboratory. The objectives of a medical laboratory are
providing its customers (physicians on behalf of patients)
accurate answers which contribute to clinical treatment..

Every achievement of management is the

achievement of a manager and every failure is the
failure of a manager.

A good manager studies management as a daily

practice. The high-performance manager is:

A strategist: one who looks to the future.

A Problem solver: one who uses his factors under

his or her control to redirect the course of action to
achieve the organisation objectives

A teacher: One who guides and helps others to

identify and solves problems

Medical Laboratory Managers

challenged to become business, as well as technical

specialists. There are many pressures on the modern
medical laboratories managers that may force it to not
only keep up to date but to move ahead in preparation
for the needs of the future. The work environment has
changed with the development of new technology.
Laboratories have always seen the need for change
and development, there has been increased pressure
to improve performance, tighten margins, improve
quality and reduce costs

Medical Laboratory Managers

Each laboratory must have a strategic plan that describes its

long-term goals, such as a move toward more automation or
molecular diagnostic techniques.
Each employees role should be clearly defined, and written
job descriptions should be provided so personnel know what
they are expected to do. Therefore, it is a not an easy task for
a manger to strike a balance among the clinical laboratory
regulations, fiscal responsibility, and employee competence
and morale to maintain the overall quality of patient care.
it is appropriate to remember that the two most important
components of management are
common sense
open communication with laboratory staff

ORGANISATION OF CLINICAL
LABORATORIES

Clinical Laboratories may be organised into different

sections. The organisation depends on the site (public
health hospital, physician office laboratory, or
independent laboratory, etc.) and the complexity of
testing. However, some general guidelines may be
applied to a situation, and they are discussed as
follows:
Microbiology Laboratory
Chemical & Biomedical Laboratory
Haematology Laboratory
Histopathology Laboratory
Molecular Biology laboratory

Microbiology Laboratory

Clinical Microbiology comprises essentially seven sections.

Aerobic and anerobic bacteriology
Mycology
Mycobacteriology (also called Acid-fast Bacteriology, AFB)
Parasitology
Virology
Serology
Molecular diagnostics (PCR & DNA probe technology)

As it was mentioned before the organisation depends on many

factors. The following is also another organisation which has
divided a General Hospital Microbiology Laboratory into 11
sections as follows:

Microbiology Laboratory

Sample Receiving & Processing Section

Samples brought to the clinical microbiology are at first received by
this section. Here sample are received and the samples are processed
according to the nature of the sample.
Urinalysis Section
In this section detailed report of urine samples including physical,
chemical, microscopic examination is be prepared.
Parasitology Section
Parasitology section deals with intestinal parasites. Samples of faeces
are examined here for the presence of any intestinal parasite. Slides are
prepared here inside a safety cabinet.
Serology Section
In serology section immunological and serological tests are performed
by different techniques like Latex agglutination, haemagglutination and
antibody absorption.
Mycobacteriology Culture & Sensitivity Section
In this section all TB smear, culture and sensitivity performed in two
Biosafety II cabinets to avoid risk of infection

Nose, Throat, Sputum and Urogenital Cultures and Sensitivity

Section
Here cultures of respiratory tract and genital tract infections are
prepared.
Wounds Culture and Sensitivity Section
Culture of wound swab, pus, aspirates, body fluids including CSF
are the responsibility of this section.
Urine Culture & Sensitivity Section
Different types of urine culture performed here including mid stream
urine and catheter samples of urine. Each sample is processed and
evaluated accordingly.
Blood Culture and Sensitivity Section
In this section culturing of blood samples is carried out. Nowadays,
this section is equipped by machines such as Bactec 9240,
flourometric instruments. Each instrument is capable of running 240
samples at a time.

Quality Control Section

In this section quality control of water, food products and
environment is performed with the help of different
media and colony counters.
Mycology Culture Section
Requests for fungus smear and culture processed here in
a bio safety II cabinet to avoid infection from fungal
spore.
Regardless of the organisation of a Microbiology
Laboratory, the main aim is providing the client (the
physician) with accurate and reliable results to assist the
process of clinical treatment.

Personnel

LAB DIRECTOR :
He/She must be a physician or a doctoral scientist
qualified to assume professional , scientific , consultative ,
organizational , administrative , and educational
responsibility for the services offered by the lab .
If a non-pathologist physician or doctoral scientist service
as director , he/she must be qualified by virtue of
documented training ,expertise , and experience in areas of
analytic testing offered by the lab .
He/She must have sufficient training and experience in
clinical medicine , sciences basic to medicine , clinical lab
sciences

Personnel

The following directorial functions are :

1- interpretation , correlation , and communication of lab data

2- interaction with physicians and/or medical staff , patient ,
administration .
3- monitoring of standard of performance , QC , QI.
4- provision of education programs , planning , research.
5- ensuring sufficient personnel with adequate documented
training and experience to meet the needs of the lab .
6- he/she must be decision-maker in the selection of all lab
equipments and supplies .

Personnel

If the lab director has delegated some responsibilities to

others , there must be documentation of which individuals
are authorized to act on his /her behalf for specific activities .

GENERAL SUPERVISOR :
Bachelor degree in chemical or clinical lab / medical
technology science with at least one year experience .

Is reponsible for day-to-day supervision of the lab operation ,

as well as personnel performing testing and reporting test
results .

Personnel

ALL PERSONNEL :
There must be an organizational chart for the lab .

Personnel policies must be documented and available to all

employees

The lab should have a complete , functional in-service

continuing clinical laboratory education program .

Personnel files must be maintained on all current employees ,

the ideal location of personnel files in the lab .

Personnel
Technical personnel records must include of all of the
following :
1- summary of training and experience .
2- description of duties .
3- records of continuing education .
4- health record .
5- incident records .
The lab must conduct an annual performance review of all
employees.
New employees must be reviewed within 6 months of
employment .

Personnel

Some elements of competency assessment of each person :

1- Direct observation of routine patient test performance ,

including patient preparation , specimen handling ,
processing and testing ;
2- Monitoring the recording and reporting of test results ;
3- Review of intermediate test results or worksheet , QC
results records ; PT results ; and preventive maintenance .

Personnel
4- Direct observation of performance of instrument
maintenance and function checks ;
5- Assessment of test performance through testing previously
analyzed specimens , internal blind testing samples or
external PT samples .
6- Evaluation of problem solving skills .

Personnel

The lab must participate in an approved program of graded

interlaboratory comparison testing appropriate to the scope of
the lab.
So that it must be enrolled in the appropriate available CAP
surveys or CAP-approved alternative PT program for patient
testing performed.
External surveys samples should be run within the routine lab
workload , and are analyzed by personnel who routinely test
patient samples using the same primarily method systems as for
patient samples.
Replicate analysis of surveys samples is acceptable only if
patient samples are routinely analyzed in the same manner.

The College of
American Pathologists
Laboratory
Accreditation Program

Personnel

If the lab uses multiple methods for an analyte surveys

samples should be analyzed by the primary method.
There should be documented evidence of active review by
the lab director or designated supervisor of the survey
results.
For analytes where graded PT is not available , performance
must be checked at least semi-annually with appropriate
procedures such as : participation in graded proficiency
surveys , split sample analysis with reference or other labs ,
assayed materials , regional pools .
It is responsibility of the lab director to define such
procedure.
There must be evidence of identification and review of
problems , and their solutions .

Quality control and Quality improvement

The QC / QI program should be clearly defined and wellorganized.

The QI program must provide the system design and evaluation

of proper patient identification and preparation ; specimen
collection ; preservation ; transportation ; storage before
testing ; processing ; and accurate results reporting.

This system must ensure optimum patient specimen and

integrity of the result throughout the pre-analytical , analytical ,
and post-analytical process.

QI / QA
supervision

Judgment of the acceptability of QC data must be made at

least monthly by the lab director or designee.

Because of many variables , the CAP makes no specific

recommendations on the frequency of any additional
assessment / review of QC data.

There must be evidence of active review of records of

instrument function , temp , and maintenance , for all
routine procedures on all shifts.

QI / QA
SUPERVISION

The lab must have documented system in operation to detect

and correct significant clerical and analytical errors.

One common method is review of results by a qualified person

before release from the lab , but there is no requirement for
supervisory review of all reported data.

The selective use of delta checks also may be useful in

detecting clerical errors in consecutive samples from the same
patient.

In computerized lab , there should be automatic alarm for

improbable results.

QI / QA
supervision

The system must provide for timely correction of

errors before results become available for clinical
decision making.

In the absence of on-site supervisor , the results

of tests performed by personnel must be reviewed
by the lab director , general supervisor , or person
in charge of the chemistry lab on the next routine
working shift.

Introduction

Microbiology Swabs eye, nose, throat, umbilical, ear, wound,

rectal, urethral and vaginal) CSF (3 samples. First for culture, second
for biochemistry and the thered for cell count)
Parasitology urine and stool)
Biochemistry (All chemistry in plane tube or heparins)

Hormones (All in plane tube or gel separating tube)

Hematology (EDTA Blood for CBC and Citrated Blood for
Coagulation

Blood bank (ask for donor replacement for any bags used to the

patient) (plane tube for crox matching and blood grouping)

Histopathology (complete identification & clinical details)



,
+

1 -2 ))GH, Cortisol, Glucose high

, , 3-

 4 *
*
* Hemolysis
*
* Tourniquet

, ,

* , ,
* , , 4
* , F glucose, TG, UA 12

 -5
.A

FSH, LH

21 progesterone
for Cortisol samples 7-10 AM & 4-8 PM
Samples for GGT should withdrew in morning hours
6- collecting specimen from canula and from limbs

receiving drips
.B

Technique
Venous stasis (tourniquet application) should always be
minimised.
Cell counts, and the levels of proteins (including enzymes) and
protein bound substances (eg. calcium, cholesterol, many
drugs) will be increased by prolonged excessive venous stasis.
Venepuncture should be clean and atraumatic.
If difficulty is experienced, the attempt should be abandoned.
A second venepuncture (preferably by a more experienced
collector) should be attempted with a new needle and syringe,
or evacuated container, at a different site

Tubes

Blood must be added to the tubes immediately but gently and without frothing.
If a syringe with needle is used, the needle must be removed before adding
blood to the specimen tubes.
If tubes containing anticoagulant are used, the correct amount of blood must be
added to the tube (usually indicated by a mark on the label) and mixed
immediately by thorough, but gentle, inversion.
Tubes should never be shaken and blood should never be poured from one
container to another.
Blood culture specimens should, if possible, be collected from a separate
venepuncture site. If a single venepuncture is necessary, the blood culture bottles
must be inoculated first.
The needle should then be removed for addition of blood to the remaining
specimen tubes.
Specimen tubes should be labelled immediately after the specimen is collected

Safety
All blood samples must be treated as potential infection risks.
Care should be taken to avoid over-filling of tubes which is likely to be
associated with leakage of blood and contamination of the external
surface of the container.
Needles must be disposed of with care into a 'sharps' container.
Syringes, swabs, or any other blood contaminated materials must be
placed in an appropriate contaminated waste container immediately after
use.
Evacuated collection systems are now frequently used for blood
collection as there is less chance of blood spillage and thus exposure to
blood-borne diseases

Specimen transport
Blood samples should be transported to the
laboratory in biohazard bags with minimum delay.
Rapid transport samples eg: PTH & glucose
If delay is inevitable it is generally better to
refrigerate samples.
However refrigeration may itself cause
artefactual changes in the results.
Samples which need ice and anaerobic
condition eg: Arterial blood gases and ammonia)

Electrolytes

Blood for electrolytes should not be refrigerated; if delay is anticipated,

plasma should be separated and stored at 4C.
Unseparated samples of blood must never be frozen.
Samples should not be subject to temperatures of >25C, even for
short periods.
Some tests involve especially labile components (eg, complement)
and blood must be transported to the laboratory immediately

Microbiological examination
Specimens for microbiological examination must be appropriate eg, sputum rather
than saliva.
In general, specimens should be collected into, and transported in, a sterile
container.
Aspirated pus may be transported in a syringe, which must be capped
immediately the needle has been removed and disposed of safely.
Specimens should be delivered promptly to the laboratory.
Although many specimens will tolerate a delay of several hours if refrigerated,
cerebrospinal fluid must be transported to the laboratory immediately, without
refrigeration.
Similarly, for the detection of Neisseria gonorrhoeae and other fragile organisms,
special arrangements may be needed: eg, express delivery, inoculation of plates at
the time and place of collection, provision of special transport containers.
Special requirements, for individual tests, are noted in the Test listing

Tube Guide
Tube content

Determination

Instructions

Heparin

Plasma testing

Produce blue background in

blood smeer

some general chemistry

(Glucose, urea,Cr)

Invert slowly several

times to ensure mixing

EDTA

Routine hematology ,
blood cont, Retc. CT.
Sickle test, Glyco HB,
HBelectro, ACTH,AS

Inhibit ALK, CK
Unsuitable for Ca
&coagulation

Plain, No additive

Hormones, General
chemistry
Blood group, RH,
Cross match,, Serology
& Allergy,

Sodium Citrate1:9

Fibrinogen, PT, PTT,

TT, ATIII, coagulation
Screen

Calating Ca,Inhibit
aminotransferase. ALK &
stimulate ACP

Invert slowly several

times to ensure mixing

Ensure tube fills

correctly to volume on
label

Shape

Sodium Citrate1:4

ESR

Plane

Urine &
Stool
analysis,

Plane

Urine &
Stool
culture

Media for
maintenance of
bacteria

Blood

Ensure the presence of anticoagulant,

Invert slowly several times to ensure
mixing

1- clean the area from which the blood

is collected by iodine
2- withdraw for 8-10 ml of blood
3- insert the blood immediately in the
vial and bring it to the lab quickly (2-3
ml for children and 5-7 ml for adult)

Type of urine specimens

1) Random specimens (drug abuse)
2) First-morning (microscopic examination, b-HCG, 8-hours)
3) 24-hours specimen
Some analyses produce in different time though 24 hours of
collection morning or noon like Creatinine, protein, Ca,
phosphors and electrolyte (the sample must be refrigerated)
4) clean-catch specimen (MSU) for bacterial culture
5) catheter specimen
6) suprapubic specimen especially for infant
7) urine collected from children
collection bags with hypoallergenic skin adhesive

If the sample left at RT

normal bacteria will multiply producing contaminated sample

if the organism urase producer, ammonia release will increase

increas
Ph resulting in destruction of cells and cast
the bacteria will break down any glucose
RBC, WBC, Cast will lyze
Protein conc will alter
Bilirubin and Urobilinogen oxidized-not detected
Uric acid and urate deposited to for oxalate or phosphate
crystal

Microbiological sample
specimen

container

instruction

sputum

Clean, wide
nick

Throat swab

Sterile swab

Early morning, cough deeply for sputum, for

children gastric wash, delay of specimen TB,
Pn, HI
Not contaminated with saliva, no antibiotic
by 8-hours

stool

Wide nick

Rectal swab

For cholera
alkaline
peptone water

Blood culture

Bld culture
bottle

Take the sample when tempt high, use iodine

for sterilization, mix it and must reach the lab
early, never refrigerated

semen

Clean and
sterile

3-7 days of sexual abstinence, no condom,

time of collection and deliver to the lab
within 2 hour

Must be fresh sample within 2 hours


:
iron, cortisol, ACTH

3

:


Catecholamine

Muscular effort

%Decrease

test

%Increase

test

ACP

11

Bilirubin

GPT

41

Iron

11

GOT

LDH

ALP

31

Potassiu
m

Calcium

Total lipid

12

Chloride

Cholesterol

Creatinine

17

Phosphorus

12

Total
ptotein

Urea

Uric acid

Haemolysis

RBC ) ,






.


.

Criteria for rejection of specimens

oMissing or inadequate identiification

oInsufficient volume
oSpecimen collected in wrong collection tube
oContamination
oInappropriate transport and storage
oUnknown time delay

Comments and Questions