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Pakistan Society Of Chemical PathologistsDistance Learning Programme In Chemical PathologyLesson No 15Laboratory Management(Short Name: LM)By Surg Commodore AamirIjazMCPS, FCPS, FRCP (Edin)Professor of Pathology / Consultant Chemical PathologistBahria University Medical &Dental College / PNS SHIFA Karachi
Q:11. MrsFarrukh is an experienced Lab Manager. She wants to install new equipment in her lab to obtain Reagent Grade Water. For purification of water she wants to use an instrument based on a process in which water is forced to pass through a semipermeable membrane. Can you guide her which type of equipment she should procure:a. Distillationb. Double Distillationc. Ion Exchanged. Reverse Osmosise. Ultraviolet Oxidation Best answer: d. Reverse Osmosis
Reagent Grade Water In lab. Pure water is needed Single distilled water == fails to meet CLRW specifications by CLSI/NCCLS Term Reagent grade water defines specifications of water independent of method of preparation
Water Purification Methods 1. Distillation 2. Deionization 3. Reverse osmosis 4. Activated carbon filtration 5. Micro porous filtration 6. Ultra filtration 7. Ultraviolet oxidation 8. Electro dialysis
Q:2: A tertiary care hospital lab has planned to install a Total Laboratory Automation System. The most suitable type of centrifuge to be used in this system should be: a. Angle head b. Automatic balancing c. Axial with vertical tubes d. Swinging bucket e. Ultracentrifuge Best answer: • b. Automatic balancing
Types of centrifuges Horizontal head or swinging buckets Fixed angle or angle head Axial type Ultracentrifuge Special types Immunofuge Cytospin Blood bag centrifuge Gerber centrifuge
Horizontal head or swinging buckets The rotors contain pairs of buckets that swing freely Rotors hold the tubes in a vertical position when the centrifuge is at rest The tubes move to & remain in a horizontal position when the rotor is in motion During centrifugation particles constantly move along the tube while it is in the horizontal position distributing the sediment uniformly against the bottom of the tube After centrifugation is complete and the rotor has ceased turning, the surface of the sediment is flat with a column of liquid above it
Fixed angle or Angle head In the rotor of an angle-head centrifuge, tubes are held in a fixed position at angles from 25 – 40 degrees to the vertical axis of rotation Particles are driven outward horizontally but strike against the side of the tube so that the sediment packs against the side & bottom of the tube with the surface of the sediment paralleled to the shaft of centrifuge As the rotor slows down & stops, gravity causes the sediment to slide down the tube & a poorly packed pellet is formed It allows more rapid sedimentation of small particles as the fixed angle rotors can be run at a higher speed
Axial type In this type the tubes of blood are allowed to be spun in a vertical orientation
Ultracentrifuge Rotates at high speeds e.g. 90,000 to 100,000 rpm, generating a max. RCF of 178,000×g An ultracentrifuge is a very high speed centrifuge that usually uses fixed head rotors Used in separation of chylomicrons from serum, fractionation of lipoproteins, to perform drug binding assays & to prepare tissue for hormone-receptor assays The high speeds used in such devices generate considerable amounts of heat Therefore it requires refrigerated chamber
Special types These are some special types of centrifuges for specific purposes Mechanically they fall under one of the above mentioned types The three most important are: Immunocentrifuge or Serofuge Cytospin Blood bag centrifuge Gerber centrifuge
Q:3: DrAbdurRazzak is a newly appointed Consultant Chemical Pathologist in a hospital lab. He wants to use a preservative for sample collection which does not adversely affect other analytes like urea, and produces minimum haemolysis. Which preservative is nearest to these characteristics: a. Lithium Heparin b. Sodium EDTA c. Sodium Fluoride d. Sodium Iodoacetate e. Tris-Iodoacetate Best answer: • e. Tris-Iodoacetate
Q:4: An important source of Alkaline Phosphatase (ALP) is growing bones. DrFareeha established reference ranges of ALP in children of the community in which her hospital is located. She selected subjects by excluding liver and other diseases affecting ALP. Then she determined separate reference ranges in boys and girls of various age intervals. This type of selection criteria for reference range is called: a. Age selection criteria b. Gender selection criteria c. Healthy subjects selection criteria d. Normal subjects selection criteria e. Partitioning criteria Best answer: • e. Partitioning criteria
Q:5: DrSajida wants to determine the reference range of Serum LH in women of reproductive age. She selects a group of subjects without any disorder affecting this hormone and collects their serum sample at various stages of menstrual cycle. On the basis of this information which of the following Selection Strategies you will assign to her study: a. A priori b. A posteriori c. Indirect d. Probability e. Randomized Best answer: • a. A priori
Definitions Used In Reference Ranges Partitioning Process by which a reference group is subdivided to reduce the biological variation in each group Reference Individual An individual selected , as a basis for comparison with individuals under clinical investigation through the use of defined criteria Sensitivity(clinical) The proportion of subjects with disease who have positive test results Specificity(clinical) The proportion of subjects without disease who have negative tests results
Types of Reference values Subject Based Reference Values These are based on the previous values from the same individual obtained when the individual was in defined state of health Population Based Reference Values These are obtained from a group of systematically defined reference individuals & are usually the type of values referred to when the term reference values is used without any qualifying words
Selection of Reference Individuals This selection criteria includes statements describing the source population , specifications of criteria for health or disease of interest Its based essentially on application of defined criteria to a group of examined candidates Ideally the group of reference individuals be a random sample of all individuals in the parent population who fulfill the selection criteria A separate reference values for sex, age group & other criteria are necessary
Selection of Reference Individuals Age & sex are most frequently used criteria Use of qualitative age groups are Post natal Infancy Childhood Prepubertal Pubertal Adult Premenopausal Menopausal Geriatric Height & weight are used as a criteria for categorization in children
Examples Of Partitioning Criteria For Possible Subgrouping Of Reference Group Age Sex Genetic Factors Ethnic Origin Blood Groups(abo) Histocompatibility Antigens(hla) Genes
Examples Of Partitioning Criteria For Possible Subgrouping Of Reference Group Physiological Factors Stage In Menstrual Cycle Stage In Pregnancy Physical Condition Other Factors Socioeconomic Environmental Chronological
Q:6: MS SoleNet has installed a new Laboratory Information System with state-of-the-art software and hardware in a hospital lab. The most important feature to prevent post-analytical transcriptional errors in this system will be: a. Automated analyser interface b. Bar-coding c. Electronic authorization d. Specimen tracking e. Work list creation Best answer: • a. Automated analyser interface
Components ofLaboratory Information Management System(LIMS) Components: 1. Specimen input area: A holding area where bar code labeled specimens are introduced into the system 2. Bar code reading stations: Multiple bar code readers are placed at critical locations in the processing system to track specimens and provide information for their proper routing to various stations in the processing system 3. Transport system: Segments of a conveyor belt line that move specimens to the appropriate location
Components of LIMS (cont) 4. A high-level device to sort or route specimens: A device that separates specimens by type (such as by tube height) or by order code and passes them to the transport system or to a system using racks A high-level sorter is often used to separate specimens that require centrifugation, or other processing steps from specimens that do not, or to route specimens into completely different pathways within the total automation system 5. Automated centrifuge: an area of the specimen processor in which specimens requiring centrifugation are removed from the conveyor belt, introduced into a centrifuge that is automatically balanced, centrifuged (either refrigerated or at room temperature), and then removed from the centrifuge and placed back on the transport system
Components of LIMS (cont) 6. Level detection and evaluation of specimen adequacy: an area in which sensors are used to evaluate the volume of specimen in each specimen container and to look for the presence of hemolysis, lipemia, or icterus 7.Decapper station: an area or device in the automated system in which specimen caps or stoppers are automatically removed and discarded into a waste container 8. Recapper station: an area or device in the automated system in which specimen tubes are automatically recapped with new stoppers or covered with an air-tight closure
Components of LIMS (cont) 9. Aliquoter: Aspirates appropriately sized aliquots from each original specimen container and places them into bar coded secondary specimen containers for sorting and transport to multiple analytical workstations 10. Interface to automated analyzer: A direct physical connection to an automated analyzer that permits the analyzer's sampling probe to aspirate directly from an open specimen container while the container is still on the conveyor, or that may robotically lift the container from the conveyor and place it in the analyzer This interface is important to decrease post analytical errors
Components of LIMS (cont) 11. Sorter: An automated sorter to sort specimens not going to a conveyor interfaced analyzer or workstation Such a sorter typically sorts into 30 to 100 different sort groups in racks or carriers. In some systems the racks are specific to certain analyzers for convenience 12. Take-out stations: Temporary storage areas for specimens before or after analysis The take-out station may be the same as the sorter described above where specimens are sorted for manual delivery. However, it may also serve as a holding area (stockyard) for specimens awaiting auto verification of results in case a repeat test is required
Components of LIMS (cont) Storage and retrieval system. This unit may serve the same function as the take-out station or stockyard-that of holding specimens after analysis in case a specimen is necessary for a repeat test, but it has one major difference These units are typically refrigerated and hold many more specimens (3 to 15,000) than the typical take-out station or stockyard Specimen containers are loaded and retrieved with a robot
Q:7: DrReza has recently returned from USA after obtaining a Fellowship in Clinical Chemistry. He wants to ensure Health and Safety of all his lab workers. To ensure best professional practice he has followed the guidelines from Occupational Safety and Health Administration (OSHA) in all of the following aspects of Lab Safety EXCEPT: a. Chemical hygiene plan b. Education and motivation of lab workers c. Personal protective equipment d. Safety inspections e. Tuberculosis exposure control Best answer: • e. Tuberculosis exposure control
Q:8: Prof Sikandar is head of the Pathology Department with all modern facilities. Microbiology Section of this department performs diagnostic tests for some important microorganisms. He wants to protect these organisms from intentional removal from the lab for a foul play. He develops certain procedures for this purpose. All these procedures come under the category of: a. Infection Control b. Laboratory Biosafety c. Laboratory Biosecurity d. Risk control e. Risk mitigation Best answer: • c. Laboratory Biosecurity
Q:9: DrZia Ul Islam is heading a large hospital lab network spread in whole of the country. He wants to get his laboratory accredited in Pakistan. Which of the following International Standard he should adopt for preparation of this accreditation (Options are not alphabetical order): a. ISO 22870:2006 b. ISO 9001:2000 c. ISO/TR 22869:2005 d. ISO/TS 22367:2008 e. ISO 15189:2012 Best answer: • e. ISO 15189:2012
Q:10: DrRabia is working on her M.Phil. project. She wants to evaluate diagnostic accuracy of Serum Hyaluronic Acid as a marker of Liver Fibrosis. Which of the following is the most important pre-requisite for her project? a. Convenience sampling b. Double Blinding c. Gender matching d. Randomization of samples e. Using a reference standard Best answer: • e. Using a reference standard
Evidence-based Laboratory Medicine It is defined as the judicious and explicit use of best available evidence in the use of laboratory medicine investigations in making decisions about the care of individual patients.
Goals of Evidence-based Laboratory Medicine Characterization of diagnostic accuracy of tests Outcome studies Systematic reviewing of studies of diagnostic accuracy or outcomes of tests Economic evaluation of tests Audit of performance of tests
Characteristics Of Diagnostic Accuracy (DA) of Tests When a new test is developed or an old test is applied to a new clinical question, users need information about the extent of agreement of the test’s result with the correct diagnoses of patients STUDY DESSIGN In the study of DA, the results of one test often referred to as the index test, which is the test of interest are compared with those from the reference standard The reference standard is the best available method for establishing the presence or the absence of the target condition The reference standard can be Single Test Combination of Methods and Techniques
Q:11: Dr Farah is the Consultant Incharge of the Endocrinology Lab. During the last one year she has introduced some SOPs resulting in much higher clinicians’ satisfaction. But one fine morning her Lab Manager reports that stock of Beta HCG reagent kits is near exhaustion. Puzzled with this information she carries out an inventory audit of the Lab Kit Store and finds some discrepancy in the consumption of Beta HCG kits. Average number of patient samples tested per kit came out to be only 65 against 80-85 in other Chemiluminescence kits. Please help her find answers of following queries to solve the puzzle: What could be the probable reason of this discrepancy after ruling out misappropriation (unauthorized use etc.)? What measures she should take to avoid such inadvertent shortage of Beta HCG kits in future? Can you name ONE other test done by Chemiluminescence Method in which similar problem can arise? .
Suggested Answer to Q.11a What could be the probable reason of this discrepancy after ruling out misappropriation (unauthorized use etc.)? Excessive use of beta HCG kit due to repeating of test with DILUTION because of high beta HCG This is because of a very wide AnalyticalMeasurement Range of Beta HCG (from < 1 to 1 million). No commercial kit is available which can have such high upper limit so dilution is necessary.
Suggested Answer to Q.11b What measures she should take to avoid such inadvertent shortage of Beta HCG kits in future? While calculating demand some 10-15% extra kits should be added keeping in mind this extra workload due to dilutions. Clinician should be persuaded to write notes on request forms so that the dilution can be carried out in the first run where required. . .
Suggested Answer to Q.11c Can you name ONE other test done by Chemiluminescence Method in which similar problem can arise? Serum Ferritin estimation in patients with Thalassemia Major has a wide range and may require frequent dilutions. .
Q:12:Dr Reza (mentioned in Q.7 above) wants to implement guidelines based on OSHA regulation in his lab. Please answer following queries to help him: From where he should start i.e. what should be first step? Considering the Education level and Professional Competency of our lab workers what should be the most important part of launching a Lab Safety programme in our labs? Name (and only name) the various types of hazards which should be identified and dealt with in a Chemical Pathology Lab.
Suggested Answer to Q.12a From where he should start i.e. what should be first step? Appointment of a Lab Safety Officer or a Lab Safety Committee headed by a trained member. .
Suggested Answer to Q.12b Considering the Education level and Professional Competency of our lab workers what should be the most important part of launching a Lab Safety programme in our labs? Education and awareness campaign .
Suggested Answer to Q.12c Name (and only name) the various types of hazards which should be identified and dealt with in a Chemical Pathology Lab. (Plz see next slide) .
Q:13:Selection and writing research projects (synopsis) is one of the major problems a PG in any discipline of Pathology faces in the initial part of her/his career. One reason for this problem is lack of realization of the fact that Laboratory Research Projects are basically different from Clinical Studies. Unfortunately lack of awareness of this fact leads to confusion. Please answer following queries in this regard: Name TWO major designs of study which a Pathologist (or would be Pathologist) can use for her / his studies. Find a very useful checklist which can be helpful in designing such studies
Suggested Answer to Q.13 a Name TWO major designs of study which a Pathologist (or would be Pathologist) can use for her / his studies. Diagnostic Accuracy Outcome Studies .
Suggested Answer to Q.13 b Find a very useful checklist which can be helpful in designing such studies STARD (Standards for Reporting of Diagnostic Accuracy) .
Q:14:Laboratory Accreditation has been started in Pakistan. All labs should get accreditation at any point of time in future as this will ultimately become a legal requirement. Please carry out a good literature search (which you are expert now) and answer following queries: Name the regulatory body which carries out accreditation in Pakistan. What are the four levels of documentation needed for Lab Accreditation?
Suggested Answer to Q.14 a Name the regulatory body which carries out accreditation in Pakistan. PNAC: Pakistan National Accreditation Council .
Suggested Answer to Q.14 b What are the four levels of documentation needed for Lab Accreditation? Policies Processes Procedures Records. .
