Laboratory Manegment

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Laboratory Manegment
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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..

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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

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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

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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

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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

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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

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Microbiology Laboratory

• Sample Receiving Processing SectionSamples
  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 SectionIn this section detailed
  report of urine samples including physical,
  chemical, microscopic examination is be prepared.
  
•   Parasitology SectionParasitology 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 SectionIn serology section
  immunological and serological tests are performed
  by different techniques like Latex agglutination,
  haemagglutination and antibody absorption.
• Mycobacteriology Culture Sensitivity
  SectionIn this section all TB smear, culture and
  sensitivity performed in two Biosafety II
  cabinets to avoid risk of infection

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• Nose, Throat,  Sputum and Urogenital Cultures and
  Sensitivity SectionHere cultures of respiratory
  tract and genital tract infections are prepared.
•   Wounds Culture and Sensitivity SectionCulture
  of wound swab, pus, aspirates, body fluids
  including CSF are the responsibility of this
  section.
•   Urine Culture Sensitivity SectionDifferent
  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 SectionIn 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.

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Quality Control SectionIn this section quality
control of water, food products and environment
is performed with the help of different media and
colony counters. Mycology Culture
SectionRequests 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.
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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

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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 .

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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 .

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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 .

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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 .

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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 .

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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 .

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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.

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The College of American Pathologists Laboratory
Accreditation Program
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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 .

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Quality control and Quality improvement

• The QC / QI program should be clearly defined and
  well-organized.
• 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.

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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.

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QI / QASUPERVISION

• 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.

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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.

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Laboratory investigation
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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)

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5- ????? A.   ??? ??????? ?? ???? ????? ????
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?????? FSH, LH ??? 21 ?????? progesterone   
for Cortisol samples  7-10 AM 4-8 PM    Samples
for GGT should withdrew in morning hours ????
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6- collecting specimen from canula and from limbs
receiving drips
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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

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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

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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

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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)

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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
  gt25C, even for short periods.
• Some tests involve especially labile components
  (eg, complement) and blood must be transported to
  the laboratory immediately

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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

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Tube Guide
Tube content Determination Instructions Shape
Heparin Produce blue background in blood smeer Plasma testing some general chemistry (Glucose, urea,Cr) Invert slowly several times to ensure mixing
EDTA Inhibit ALK, CK Unsuitable for Ca coagulation Routine hematology , blood cont, Retc. CT. Sickle test, Glyco HB, HBelectro, ACTH,AS Invert slowly several times to ensure mixing
Plain, No additive Hormones, General chemistry Blood group, RH, Cross match,, Serology Allergy,
Sodium Citrate19 Calating Ca,Inhibit aminotransferase. ALK stimulate ACP Fibrinogen, PT, PTT, TT, ATIII, coagulation Screen Ensure tube fills correctly to volume on label
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Sodium Citrate14 ESR Ensure the presence of anticoagulant, Invert slowly several times to ensure mixing
Plane Urine Stool analysis,
Plane Urine Stool culture
Media for maintenance of bacteria Blood 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)
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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
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If the sample left at RT
Ø  normal bacteria will multiply producing
contaminated sample
Ø  if the organism urase producer, ammonia
release will increase Ph resulting in destruction
of cells and cast
Ø  the bacteria will break down any glucose
Ø  RBC, WBC, Cast will lyze
Ø  Protein conc will alter
Ø  Bilirubin and Urobilinogen oxidized-not
detected
Ø  Uric acid and urate deposited to for oxalate
or phosphate crystal
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Microbiological sample
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  ?????? ??????
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  ??? ????? ????? ???? ???? ?? ?????? ??????

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?????? ?????? ??? ??? ???? ?? ????? Catecholamine
?????? ???? ??? ????? ??? ??? ??????? ?? ????
?????? ?????
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Decrease test Increase test
4 Bilirubin 11 ACP
11 Iron 41 GPT
1 LDH 3 GOT
8 Potassium 31 ALP
12 Total lipid 1 Calcium
1 Chloride
3 Cholesterol
17 Creatinine
12 Phosphorus
3 Total ptotein
3 Urea
4 Uric acid
??????? ?????? Muscular effort ???? ???????
?????? ??? ?????? ?? ??????? ???????? ?? ?????
????? ??? ???????? ?? ??????? ??? ?? ????
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• ??????? ??????? ??? ??????? ??? ??? ????
• ?????? Haemolysis
• ???? ?? ???? RBC ????? (??? ?????? ?? ????
  ????, ??????? ??? ?????? ??? ??? ???? ???? ????

• ??????
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  ??????? .

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Criteria for rejection of specimens

• Missing or inadequate identiification
• Insufficient volume
• Specimen collected in wrong collection tube
• Contamination
• Inappropriate transport and storage
• Unknown time delay

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Comments and Questions