3 M LABORATORY SERVICES          IHMR-Bangalore          Compiled By          Dr Ratnesh Pandey
•   3 M LABORATORY SERVICES•   MANAGING•   MONITORING &•   MASTERING
Outline Introduction              Lab Safety Defining Lab & Lab        Planning  Services                  Staffing ...
 A medical laboratory is a place where tests  are done on clinical specimens and samples in  order to get information abo...
Medical                      Laboratories   Clinical             Clinical            Clinical  Pathology           Microbi...
What are Laboratory Services all             about?  Laboratory Services play a critical role in the detection,  diagnosis...
Services we provide..• Microbiology• Parasitology• Virology• Haematology• Coagulation• Clinical Biochemistry• Toxicology• ...
• Urinalysis• Histopathology• Cytopathology• Electron microscopy• Genetics• Cytogenetics• Surgical pathology• Immunology/S...
Lab equipments    and LIS
Planning for equipments• Basic instruments and equipments should  be made available• All vital equipment should be in dupl...
Following element should be consideredduring management program in laboratory:  1) Selection and purchasing  2) Installati...
Lab equipmentsBasic equipments for all types of routine investigations are:1) Colorimeter/Photoelectric colorimeter:    It...
Continued………………………….4) Microscope- Mono Ocular/binocular:Is an instrument used to see objectsthat are too small for the na...
Lab equipments8)   Incubator:     Is a device used to grow and maintain of course     microbiological cultures or cell cul...
Continued……..12) Microtome:Is a tool used to cut extremely thin slices of material, known as sections. Its used in microsc...
LIS• A lab information system ("LIS") is a class of software that  receives, processes, and stores information generated  ...
Lab information system
Key Features• The lab machines including the auto  analyzers are interfaced with the hospital  information system and thei...
Continued…………………………..• Assures that the technicians complete all the  pending tests• Generates automated results from vari...
Benefits of Lab Information               SystemDoctors• The lab results of critical patients would be notified  instantan...
The functionalcomponents of theclinical Laboratory
FUNCTIONS OF THE         CLINICAL LABORATORY• Identify the chemical composition of blood  and urine samples• Identify and ...
The functional components of the        clinical Laboratory• A hospital laboratory work generally  falls under the followi...
Hematology• Hematology :-The study of blood. This  section counts and qualifies the different types  of blood cells and ot...
Serology• Serology - The study of serum for its  antibody content. Certain microorganisms  (antigens) stimulate the body t...
Clinical Chemistry/Biochemistry• Chemistry - Performs most chemical  analyses including glucose, sodium,  potassium, and c...
Urinalysis• Urinalysis - The study of urine for the  purpose of medical diagnosis. Urine is  initially examined for such c...
Microbiology• Microbiology - The study of  microorganisms, including viruses, that  can only be seen with a microscope.
Blood Bank• Blood Bank - Collects, tests, types and  stores blood donations used for blood  transfusions
Functional planning  An important decision in planning for a new laboratory is the  physical location in relation to other...
Lab Safety and Rules ofthe Lab
Safety Symbols        • Know safety symbols        • They appear in your          laboratory activities        • They will...
Protect Yourself         Eye Safety• Wear safety goggles when working with chemicals,  flames, or heating devices• If you ...
Eye Safety     • In case of emergency in      • which a in water goes15         Flush chemical for        into one’s eye, ...
Proper Attire                                     • Keep all long hair                                       tied back    ...
Hand Safety• If a chemical spills on your skin, rinse with water  for 15 minutes• Wash hands after every lab              ...
Sharp Objects• Always carry sharp objects  with points and tips facing  down• Never try to catch falling  sharp instrument...
Electrical Safety• Only electrical plugs are  to be placed into an  electrical outlet• Unplug electrical  equipment after ...
Physical Safety                  • Handle all equipment carefully                  • Do not place a cord where            ...
Heating Safety• Tie back hair and loose  clothes when working  with open flames• Never look into a  container as you  are ...
Heating Safety• Never leave a heat source unattended• Heated metal and glass looks  cool, use tongs or gloves  before hand...
Chemical Safety• Read all labels twice before removing  a chemical from the container                   • Only use the typ...
Chemical Safety• Transfer chemicals carefully!• Keep lids on chemical  containers when not in use• When diluting an acid, ...
don’ts…• Enter store room  unless given  permission• Take any chemicals  from lab or store  room• Touch any equipment,  ch...
Continued…• Eat or drink in the lab• Use lab glass-ware to  eat or drink out of
Continued…• Engage in….  – practical jokes  – horse play  – rough house
In case of anemergenCy…      • Know the locations of:         – fire extinguisher         – fire blanket         – body sh...
In case of anemergenCy…      • Know the locations of:         – fire extinguisher         – fire blanket         – body sh...
In case of anemergenCy…      • Know the locations of:         – fire extinguisher         – fire blanket         – body sh...
remember to…   • Stay at your work station   • Maintain a clean work area   • Read and follow all directions   • Report an...
Planning forlaboratory services
Facility design ProcessStages               activitiesSituation analysis   Needs assessment staffing needs                ...
The planning of laboratoryservices depends on following          factors:-            Planning
Planning of Infrastructure• Depends on type of services to be provided• Work load   Two types of Infrastructure:-1) Tradit...
Infrastructure Planning     Environmental           Location     consideration                                        ADMN...
Central Lab unit1) Administrative area:-•    Office of pathologist•   Record room•   Administration Office•   Patient Wait...
Continued….4) Functional Area:-•   Haematology area•   Biochemistry•   Stool and urine•   Cytology•   Microbiology•   Hist...
Continued…7)Environmental consideration:-•   Floor should be strong,acid and stain resistant, grease proof•   Walls washab...
Suggested dimensions for               interiorLaboratory counter width                  2feet 6 inchesLaboratory counter ...
Floor Plan  H   A  E           Urinol  M               ysis        Bioc                            Serology  A            ...
Space Utilization Chart (Rules           of Thumb)
Infrastructure costing1 unit (land requirement)       200sqr feet8 functional unit               1600 sqr feetrest        ...
Lab equipment costingEquipment                         Cost (Rs.)Colorimeter                       25,000Centrifuge       ...
Activity Planning                    From Different                       HospitalRegistration            Patients        ...
RESEARCH• Research is an integral part of Laboratory  system• Various research projects pertaining to Lab‟s  functioning, ...
PERSONNEL, TRAINING AND          DEVELOPMENT• Each laboratory should designate a Head of  the laboratory and a Quality Man...
CONTinueD….• A programme for technical training and updating of skills on a regular  basis should be in place• Laboratory ...
QUALITY ASSURANCE• Quality Assurance (QA) is the total process  whereby the quality of laboratory reports can  be guarante...
QUALITY ASSURANCE PROGRAMME              (QAP)• QAP is a managerial process of maintaining high standards  of performance ...
NABL• NABL accreditation is a formal recognition of the  technical competence of a testing, calibration or  medical labora...
Contd…• NABL Accreditation is currently given  in the following fields:                                                   ...
A qualified individual is responsible for    managing the laboratory service
Responsibilities for managing the       laboratory servicesIt includes:• Developing service-related policies and procedure...
An individual with adequate training, skills,orientation and experience administer tests          and interpret the results.
For the laboratory services, is it sufficient  that the laboratory director meets the   experience, education and training...
Under CLIA,         NO, in addition the laboratory director     must demonstrate active involvement in the     laborator...
As per CLIA,Laboratory Director must ensure that: the pre-analytic, analytic and post-analytic phases oftesting are appro...
Personnel positionsModerate Complexity    High complexity testing  testingTechnical consultant   Technical supervisorClini...
Introduction to the Manual of         Clinical Policies• Operating Policy Manual• Policies and Procedures Health  Informat...
PoliciesProcessesProcedures
General Standards•   Hours•   Meetings/Communications•   Specimen Handling•   Specimen Storage•   Panic Values•   Referenc...
In House & Reference Lab Specimen Labelling                    and       Specimen Collection Procedures• “Routine” Specime...
General Maintenance and Repair           Responsibilities• Lab Instruments• Preventive Maintenance• Refrigerator Maintenan...
• Patient Complaints• Personnel Responsibilities/Job Description• Reporting of Communicable Diseases
Daily Log of Tests Ordered:    Procedure to Print and Computer        Data Entry Procedures A. Patient Telephone Numbers• ...
General Policy• ISSUE:• Duties of Medical Laboratory Assistant (MLA) or Lab  Assistant (LA)• BACKGROUND:• The Medical Labo...
POLICIES• A medical laboratory assistant may, under the qualified laboratory  professional, perform a list of tasks that a...
Billing and Reporting•   Online by accessing our site•   Via mail•   Massage on mobile•   Letter•   Via Telephone•   Custo...
ROLE OF ADMINISTRATOR INLABORATORY SERVICES
LABORATORY MANAGER??• A laboratory manager is a uniquely skilled  employee with a very high level of daily  responsibility...
PLANNING                                             ORGANIZING-Selecting a planning group                          - Time...
PLANNING                                           ORGANIZING                        A key management task is to - Time ma...
PLANNING                                      ORGANIZING-Selecting a planning group                    - Time management- ...
PLANNING                                           ORGANIZING-Selecting a planning group                           - Time ...
• The technical aspects of running a laboratory  are codified and tightly regulated. When  technical problems arise, there...
SOURCE• http://labmed.ascpjournals.org/conten  t/37/7/397.short
Laboratory services in hospital by ihmr b
Laboratory services in hospital by ihmr b
Laboratory services in hospital by ihmr b
Laboratory services in hospital by ihmr b
Laboratory services in hospital by ihmr b
Laboratory services in hospital by ihmr b
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Laboratory services in hospital by ihmr b

  1. 1. 3 M LABORATORY SERVICES IHMR-Bangalore Compiled By Dr Ratnesh Pandey
  2. 2. • 3 M LABORATORY SERVICES• MANAGING• MONITORING &• MASTERING
  3. 3. Outline Introduction  Lab Safety Defining Lab & Lab  Planning Services  Staffing Types of Lab  NABL Lab Services  Research & Training Importance of Lab  Policies Services  Procedures Lab Equipment  Role of Administration Lab Information System  Conclusion Lab Services Lab Medicines
  4. 4.  A medical laboratory is a place where tests are done on clinical specimens and samples in order to get information about the health of a patient as pertaining to the diagnosis, treatment, and prevention of disease Laboratory Services include testing of materials, tissues or fluids obtained from a patient or clinical studies to determine the cause and nature of disease
  5. 5. Medical Laboratories Clinical Clinical Clinical Pathology Microbiology BiochemistryHaematology Bacteriology Biochemical analysisHistopathology Mycobacteriology  Hormonal assaysCytology  VirologyRoutine Pathology Mycology Parasitology Immunology  Serology
  6. 6. What are Laboratory Services all about? Laboratory Services play a critical role in the detection, diagnosis and treatment of disease. Samples are collected and examination and analysis of body fluids, tissue and cells are carried out. Main services are: To Perform diagnostic tests To Identify organisms, like E-coli bacteria To Count and classify blood cells to identify infection or disease To Operate complex diagnostic equipment To Perform immunological tests to check for antibodies To Type and cross-match blood samples for transfusions To Analyze DNA
  7. 7. Services we provide..• Microbiology• Parasitology• Virology• Haematology• Coagulation• Clinical Biochemistry• Toxicology• Immunohaematology/Blood bank
  8. 8. • Urinalysis• Histopathology• Cytopathology• Electron microscopy• Genetics• Cytogenetics• Surgical pathology• Immunology/Serology
  9. 9. Lab equipments and LIS
  10. 10. Planning for equipments• Basic instruments and equipments should be made available• All vital equipment should be in duplicate or have an alternative arrangement• Selecting the best instrument for the laboratory is a very important part of equipment management
  11. 11. Following element should be consideredduring management program in laboratory: 1) Selection and purchasing 2) Installation 3) Calibration and performance evaluation 4) Maintenance 5) Troubleshooting 6) Service and repair 7) Retiring and disposing of equipment
  12. 12. Lab equipmentsBasic equipments for all types of routine investigations are:1) Colorimeter/Photoelectric colorimeter: Its a device that measures the absorbance of particular wavelengths of light by a specific solution2) Centrifuge: Is a piece of equipment, generally driven by an electric motor that puts an object in rotation around a fixed axis, causing denser substances to separate and by which lighter objects will tend to move on top3) Water Bath: A device for regulating the temperature of anything subjected to heat, by surrounding the vessel containing it with another vessel containing water which can be kept at a desired temperature
  13. 13. Continued………………………….4) Microscope- Mono Ocular/binocular:Is an instrument used to see objectsthat are too small for the naked eye5) Hot air oven:Are electrical devices used in sterilization6) Autoclave:Is a device used to sterilizeequipment and supplies by subjecting them tohigh pressure saturated steam at 121 C for around15–20 minutes depending on the size of the loads7) Ph-meter: is an electronic instrument used formeasuring the pH (acidity or alkalinity) of a liquid
  14. 14. Lab equipments8) Incubator: Is a device used to grow and maintain of course microbiological cultures or cell cultures9) Automated biochemistry analyzer: Is an instrument designed to measure different chemicals and other characteristics in a number of biological samples quickly, with minimal human assistance11) Enzyme-linked immunosorbent assay(ELISA) -Reader : Uses one sub-type of heterogeneous, solid- phase enzyme immunoassay (EIA) to detect the presence of a substance, usually an antigen, in a liquid sample or wet sample
  15. 15. Continued……..12) Microtome:Is a tool used to cut extremely thin slices of material, known as sections. Its used in microscopy, allowing for the preparation ofsamples for observation under transmitted light or electron radiation14) Wax melting bath: Its a device used for electric melting of glues, vinyl compounds, waxes etc. with bottom valve discharge. Heaters are positioned such that melter may be used 1/3, 2/3 and full capacity without overheating contents15) Hot plate:A hot plate is a portable self-contained tabletop smallappliance that features one, two or more gas burnersor electric heating elements
  16. 16. LIS• A lab information system ("LIS") is a class of software that receives, processes, and stores information generated by medical laboratory processes. These systems often must interface with instruments and other information systems such as hospital information systems (HIS)• A LIS is a highly configurable application which is customized to facilitate a wide variety of laboratory workflow models• It is a complete management system that handles all business functions from patient management, results generating, to physician decision making
  17. 17. Lab information system
  18. 18. Key Features• The lab machines including the auto analyzers are interfaced with the hospital information system and their complete operations are automated without human intervention• HL7 standards incorporates the ability to receive data from other lab machines• Sample management system creates barcodes and tracks the samples of blood, saliva, urine etc.
  19. 19. Continued…………………………..• Assures that the technicians complete all the pending tests• Generates automated results from various laboratory machines and updates patient records• Ability to handle large number of specimens without compromising on safety• Efficient tracking of specimens by usage of bar codes for the specimens
  20. 20. Benefits of Lab Information SystemDoctors• The lab results of critical patients would be notified instantaneously to the doctor• All the lab results would be submitted directly to the doctorPatients• No delay in the execution of doctors‟ orders• No need to make repeat visits to collect the results• No mix-up of samples of different patients at the labLab Technician• Immediate receipt of the doctors‟ orders to perform a lab test• Easier reporting of lab results of the patients
  21. 21. The functionalcomponents of theclinical Laboratory
  22. 22. FUNCTIONS OF THE CLINICAL LABORATORY• Identify the chemical composition of blood and urine samples• Identify and count the different types of cells found in blood and other body fluids• Blood typing and determination of transfusion compatibility between blood donors and recipients• The culturing and identification of bacteria and viruses from sites of infection in the body
  23. 23. The functional components of the clinical Laboratory• A hospital laboratory work generally falls under the following divisions:• Hematology• Serology• Clinical Chemistry/Biochemistry• Urinalysis• Microbiology• Blood Bank
  24. 24. Hematology• Hematology :-The study of blood. This section counts and qualifies the different types of blood cells and other components found in blood
  25. 25. Serology• Serology - The study of serum for its antibody content. Certain microorganisms (antigens) stimulate the body to produce antibodies during an infection. In the Serology lab, the antibodies react with antigens in specific ways that can be used to confirm the identity of the specific microorganism
  26. 26. Clinical Chemistry/Biochemistry• Chemistry - Performs most chemical analyses including glucose, sodium, potassium, and cholesterol.
  27. 27. Urinalysis• Urinalysis - The study of urine for the purpose of medical diagnosis. Urine is initially examined for such characteristics as color, odor, and specific gravity (density relative to water). It is routinely tested for its acidity level, as indicated by its pH reading, and screened for glucose (sugar)
  28. 28. Microbiology• Microbiology - The study of microorganisms, including viruses, that can only be seen with a microscope.
  29. 29. Blood Bank• Blood Bank - Collects, tests, types and stores blood donations used for blood transfusions
  30. 30. Functional planning An important decision in planning for a new laboratory is the physical location in relation to other departments• Functional planning covers the following activity: Determining services to be provided for inpatients/outpatients, for other departments, smaller hospitals and private practitioners Determining area and space requirement to accommodate equipment, furniture and personnel in technical, administrative and auxiliary functions Dividing the area into functional units, hematology, biochemistry, microbiology, histopathology, urinalysis etc Determining the major equipment and appliances in each unit
  31. 31. Lab Safety and Rules ofthe Lab
  32. 32. Safety Symbols • Know safety symbols • They appear in your laboratory activities • They will alert you to possible dangers • They will remind you to work carefully
  33. 33. Protect Yourself Eye Safety• Wear safety goggles when working with chemicals, flames, or heating devices• If you wear contact lenses let your boss or teacher know
  34. 34. Eye Safety • In case of emergency in • which a in water goes15 Flush chemical for into one’s eye, use the mins. and notify the eyewash station teacher
  35. 35. Proper Attire • Keep all long hair tied back • Do not wear loose clothing that could catch on fire• Foot wear that completely covers the foot is required
  36. 36. Hand Safety• If a chemical spills on your skin, rinse with water for 15 minutes• Wash hands after every lab • Handle glassware, sharp tools and heated containers carefully
  37. 37. Sharp Objects• Always carry sharp objects with points and tips facing down• Never try to catch falling sharp instruments• Hold sharp instruments only by the handles
  38. 38. Electrical Safety• Only electrical plugs are to be placed into an electrical outlet• Unplug electrical equipment after use• Keep all electrical cords, wires, and appliances away from water
  39. 39. Physical Safety • Handle all equipment carefully • Do not place a cord where someone can trip over it • Push all stools in out of the way• Keep books picked up out of walking isles
  40. 40. Heating Safety• Tie back hair and loose clothes when working with open flames• Never look into a container as you are heating it• Never point the end of a test tube being heated at yourself or others • Never heat in a closed container
  41. 41. Heating Safety• Never leave a heat source unattended• Heated metal and glass looks cool, use tongs or gloves before handling• Do not place hot glassware directly on lab desk or in cold water
  42. 42. Chemical Safety• Read all labels twice before removing a chemical from the container • Only use the type and amount of chemical instructed to use • Never touch, taste, or smell a chemical unless instructed by the teacher • Never mix chemicals unless instructed to do so
  43. 43. Chemical Safety• Transfer chemicals carefully!• Keep lids on chemical containers when not in use• When diluting an acid, pour the acid into water• Consider all chemicals dangerous
  44. 44. don’ts…• Enter store room unless given permission• Take any chemicals from lab or store room• Touch any equipment, chemicals, or other materials until instructed to do so
  45. 45. Continued…• Eat or drink in the lab• Use lab glass-ware to eat or drink out of
  46. 46. Continued…• Engage in…. – practical jokes – horse play – rough house
  47. 47. In case of anemergenCy… • Know the locations of: – fire extinguisher – fire blanket – body shower – eyewash station – first aid kit
  48. 48. In case of anemergenCy… • Know the locations of: – fire extinguisher – fire blanket – body shower – eyewash station – first aid kit
  49. 49. In case of anemergenCy… • Know the locations of: – fire extinguisher – fire blanket – body shower – eyewash station – first aid kit
  50. 50. remember to… • Stay at your work station • Maintain a clean work area • Read and follow all directions • Report any spills, accidents, or injury immediately • Clean and put away all equipment at the end of the lab period • Dispose of waste products according to instruction
  51. 51. Planning forlaboratory services
  52. 52. Facility design ProcessStages activitiesSituation analysis Needs assessment staffing needs ,requirements technologic changes , current and anticipated ,identify team players(Architect, Laboratory staff, Medical staff, Interior Designer etc…)Strategic Planning Activities to be performed , flow of people and material storage, equipment to be used, utilities, laboratories sectional needs.Structural designs Identify constructional material, architectural design , cost system options(plumbing , electricity, heating, ventilation , air conditioning)Interior Design Interior Design ,Colour, Fabric,texture, finish
  53. 53. The planning of laboratoryservices depends on following factors:- Planning
  54. 54. Planning of Infrastructure• Depends on type of services to be provided• Work load Two types of Infrastructure:-1) Traditional „Closed Laboratory‟:-It has discrete sections in Hematology ,chemistry ,microbiology, and blood bank generally separated into rooms or sections2) Open laboratory:-The discrete services are placed in one large room with portable walls that can be adjusted as neededCore laboratory:-Hematology and chemistry(chematology)
  55. 55. Infrastructure Planning Environmental Location consideration ADMN areaAuxiliary Area Infrastructure Ancillary Area Size Functional area
  56. 56. Central Lab unit1) Administrative area:-• Office of pathologist• Record room• Administration Office• Patient Waiting Area• Seminar room2) Auxillary Area:-• Glass washing room• Cleaning of Instrument• Equipment sterilization3) Ancillary Area:-• Treatment and disposal of specimens• Janitors room• Chemical and reagent store
  57. 57. Continued….4) Functional Area:-• Haematology area• Biochemistry• Stool and urine• Cytology• Microbiology• Histopathology• Virology and Immunology• Blood bank 5)Size:-• depends on the functions• Generally 1 square feet per 20 samples annually• Minimum requirement for each unit are 10 feet *20 feet6) location:-Easily accessible from all hospital
  58. 58. Continued…7)Environmental consideration:-• Floor should be strong,acid and stain resistant, grease proof• Walls washable light colour,water proof ,no crevices• As far as natural light• Adequate ventilation and exhaust system• Spot light , no extension cord• Sufficient electric point• Specific investigation area to be air conditioned• Working benches-sitting type-30 inches ht• Revolving stool –standing type-36 inches ht• 3^1/2 ft space between two benches• Water sinks , hot and cold water supply, compressed gas burner
  59. 59. Suggested dimensions for interiorLaboratory counter width 2feet 6 inchesLaboratory counter to wall clearance 4 feetLaboratory counter to counter clearance 7 feetDesk height 30 inchesKeyboard drawer height 25-27 inchesHuman body standing 4 square feetHuman body sitting 6 square feetDesk space 3 square feet
  60. 60. Floor Plan H A E Urinol M ysis Bioc Serology A Histolpa Ancillary T Bioch hem Bacterio O thology Area L emist istry logy O ry G yVenipunctu Exam and Pathologist re cubicle Test office Sterilizati on Glass Tech Washing Tech Lock And Toilet ers Record Administrative Waiting Cleaning room office Area
  61. 61. Space Utilization Chart (Rules of Thumb)
  62. 62. Infrastructure costing1 unit (land requirement) 200sqr feet8 functional unit 1600 sqr feetrest 1600 sqr feettotal 3200sqr feetRate of land per sqr feet 2500(Rs.)Total cost 80,00000Extra expendicture 20,0000Total land cost 1crCost of construction+interior 75 ,00000Total sum 1.75cr
  63. 63. Lab equipment costingEquipment Cost (Rs.)Colorimeter 25,000Centrifuge 20,000Water Bath 10,000Electronic Microscope 3,25,000Hot air oven 39,330Incubator 1,30,000Ph-meter 20,000Automated biochemistry analyzer 2,00,000Enzyme-linked immunosorbent 50,000assay(ELISA) -ReaderOthers 200000Reagents 70,000-80,000Budget (per unit) 20,00,000Total budget (8 units) 1.60 cr
  64. 64. Activity Planning From Different HospitalRegistration Patients Impression Sample Reporting collection Lab Management System Result Testing Sample analysis Quality Control
  65. 65. RESEARCH• Research is an integral part of Laboratory system• Various research projects pertaining to Lab‟s functioning, equipment development, technology up gradation are a part of system management
  66. 66. PERSONNEL, TRAINING AND DEVELOPMENT• Each laboratory should designate a Head of the laboratory and a Quality Manager• The qualifications and experience of the staff outlined in NABL document 112 (2007) should be followed• The strength of staff employed should be appropriate to the level of facility and the workload• The roles and responsibilities of the staff should be clearly outlined
  67. 67. CONTinueD….• A programme for technical training and updating of skills on a regular basis should be in place• Laboratory should organize or conduct periodic staff evaluation, preferably once a year• The laboratory should maintain a personal file of all the technical and nontechnical staff employed. Personal file should contain all information on: Personal’s CV Copy of appointment letter Duly verified health information (physical fitness including color blindness, immunizations received etc.) prepared at the time of employment and its regular updates Performance appraisal Training certificates, awards/recognition received Disciplinary action if any taken by the management
  68. 68. QUALITY ASSURANCE• Quality Assurance (QA) is the total process whereby the quality of laboratory reports can be guaranteed• Incorrect Laboratory results may be due to errors occurring during pre-analytical stage, analytical stage/post-analytical stage• QA encompasses procedures adopted for minimizing errors that may occur at any stage. Provision of precise and accurate laboratory results optimize medical management
  69. 69. QUALITY ASSURANCE PROGRAMME (QAP)• QAP is a managerial process of maintaining high standards of performance and of improving standards where necessary• While planning a QAP it is important to put effort at each step to prevent, detect and correct errors• Quality Manager or designee or competent authorized person should review the quality control data and maintain record of evaluation• The two important tools toward maintaining laboratory quality are- Internal Quality Control (IQC) - for detection and minimization of immediate errors External Quality Assessment (EQA) - for monitoring long term precision and accuracy of results
  70. 70. NABL• NABL accreditation is a formal recognition of the technical competence of a testing, calibration or medical laboratory for a specific task following ISO/IEC 17025:2005, ISO 15189:2007 Standards. This is based on third party assessment• Accreditation to a laboratory is given on the basis of its capability to perform test(s) / calibration(s) and provide accurate and reliable results. A laboratory may apply for accreditation from as little as one to as many tests / calibrations provided it is performing these in accordance with NABL criteria
  71. 71. Contd…• NABL Accreditation is currently given in the following fields: • Electro- • Clinical • Biological Technical Biochemistry • Clinical Pathology CALIBRATION LABSTESTING LABS MEDICAL LABS • Chemical • Mechanical • Hematology and • Electrical • Fluid Flow Immunohaematolo • Electronics • Thermal & gy • Fluid-Flow • Microbiology and Optical Serology • Mechanical • Radiological • Histopathology • Non-Destructive • Cytopathology • Photometry • Genetics • Radiological • Nuclear Medicine • Thermal
  72. 72. A qualified individual is responsible for managing the laboratory service
  73. 73. Responsibilities for managing the laboratory servicesIt includes:• Developing service-related policies and procedures• Managing relevant human resources functions (job description, personnel evaluation, staff training)• Developing, co-ordinating, and monitoring the required quality control and improvement
  74. 74. An individual with adequate training, skills,orientation and experience administer tests and interpret the results.
  75. 75. For the laboratory services, is it sufficient that the laboratory director meets the experience, education and training requirements???
  76. 76. Under CLIA,  NO, in addition the laboratory director must demonstrate active involvement in the laboratory‟s operation and be available to the laboratory staff, as needed.
  77. 77. As per CLIA,Laboratory Director must ensure that: the pre-analytic, analytic and post-analytic phases oftesting are appropriate for the patientsphysical and environment conditions of thelaboratory are adequate and appropriate for thetesting performeda general supervisor is available to provide day-to-day supervision of all testing personnel each employee’s responsibilities and duties arespecified in writing
  78. 78. Personnel positionsModerate Complexity High complexity testing testingTechnical consultant Technical supervisorClinical consultant Clinical consultantTesting personnel General supervisor Testing personnel
  79. 79. Introduction to the Manual of Clinical Policies• Operating Policy Manual• Policies and Procedures Health Information• Policies and Procedures Environmental Health and Safety• Policies and Procedures General Operations• Policies and Procedures on the use of ionizing radiation
  80. 80. PoliciesProcessesProcedures
  81. 81. General Standards• Hours• Meetings/Communications• Specimen Handling• Specimen Storage• Panic Values• Reference Ranges• Lab Errors• Lab Results• Reportable Diseases• Patient Identifiers
  82. 82. In House & Reference Lab Specimen Labelling and Specimen Collection Procedures• “Routine” Specimens• Urine• Gynaecological Specimens• Blood Collection, Finger Stick and Phlebotomy• Stool Occult Blood/O&P/C&S• Lab Specimen Containers
  83. 83. General Maintenance and Repair Responsibilities• Lab Instruments• Preventive Maintenance• Refrigerator Maintenance• General Procedure Manual for Lab Equipment• Continuing Education and In-services• New Employee Orientation Guidelines & Proficiency• Documentation
  84. 84. • Patient Complaints• Personnel Responsibilities/Job Description• Reporting of Communicable Diseases
  85. 85. Daily Log of Tests Ordered: Procedure to Print and Computer Data Entry Procedures A. Patient Telephone Numbers• Entering Provider UPIN #’s• Bill Code TypesB. Employee Lab Work• 1. New Hires• 2. Introductory Period• 3. Under Insurance• 4. Workers’ CompC. Medicare Patients – limited coverage tests• Certain Lab Tests & Additional Information• Results Procedure
  86. 86. General Policy• ISSUE:• Duties of Medical Laboratory Assistant (MLA) or Lab Assistant (LA)• BACKGROUND:• The Medical Laboratory Assistant is an integral member of the health care team. The MLA is responsible and accountable for his/her professional actions and practices according to established standards of practice.• The defined activities of a laboratory assistant are the ultimate responsibility of the Laboratory Director or designated qualified professional, but follow the curriculum of a recognized MLA training course.
  87. 87. POLICIES• A medical laboratory assistant may, under the qualified laboratory professional, perform a list of tasks that are considered pre-analytic and post-analytic, and do not require interpretation or assessment. Specific work assignments should only be undertaken subsequent to thorough, documented training and instruction by qualified supervisory personnel• Transfusion Medicine testing is restricted to persons trained in Transfusion Medicine.Examples of tasks may include: blood sample procurement• Procurement may include, but is not restricted to patient identification; collection and labelling; accessioning/handling; specimen rejection; specimen referral.• sample preparation for analysis, to include centrifugation, separation, numbering, aliquoting
  88. 88. Billing and Reporting• Online by accessing our site• Via mail• Massage on mobile• Letter• Via Telephone• Customer care
  89. 89. ROLE OF ADMINISTRATOR INLABORATORY SERVICES
  90. 90. LABORATORY MANAGER??• A laboratory manager is a uniquely skilled employee with a very high level of daily responsibility that spans all areas of the organizationThey are “extenders” of the physician directors.
  91. 91. PLANNING ORGANIZING-Selecting a planning group - Time management The objective of planning is to set an- Environmental analysis achievable course of action by - Organization chart- SWOT analysis A knowledgeable andananalysis is a where day- An environmental environment establishing motivated group -Policies- Vision and Mission statements systematic the laboratory are well-controlled, to-day activi-tiesinternal be from withinreview Procedures and - of the should assembled to create and administerunderstood by measurable, and thoroughly external factors that influence thea- Goals, Objectives & strategies - Staffing and scheduling strategic plan. This group must includeof of what operation articulate every level the employees at visualization A vision statement sets anof the laboratory.-Prioritization organization. key people from all functional areas. the organization seeks to become at some point. A- Accountability A practical implementation timeline should be developed. missionnecessary to assigncertain fundamental questions It is statement answers priorities by weighing the-Measuring success For most must have built-inhand to determine purpose?” importanceorganization,atlaboratories, a planning horizon about the of themedical accountability.our which have A plan modern tasks such as “What is This amountsof 18 monthsamechanism must order to ac- “InA regularassigning to 2 be precedence. established what activities will we years is practical. the highest level of immediate engaged inbe Therefore, to reporting specific individual to LABORATORY ensure for each that purpose?” be responsible complishaction item“must do” monitor to review a MANAGER to planning is oftenprogress on action items and toand “want struggle between changes in follow-through. to do” decisions. environment. Monthly, or perhaps even weekly, meetings should be scheduled to discuss progress toward stated goals and objectives. DIRECTING CONTROLLING- Communicating - Evaluating Performance- Delegating - Decision making- Motivating- Coaching
  92. 92. PLANNING ORGANIZING A key management task is to - Time management-Selecting a planning group organize the activities of the- Environmental analysis - Organization chart laboratory in such a way that effort- SWOT analysis An circumstances,chart helps to-Policies and In all organizationalare manager should set and expenditures a mini- mizedclarify- Vision and Missionand output is areschedule, building enough adhere to a reasonable lines, and areas of workflow, reporting “Laws” of - Procedures Policies statements maximized. A laboratory manager day for essential - Staffing and scheduling time into the understand listing responsibility by maintain meetings,- Goals, Objectives & strategiesmustexplicitly set of laboratories. current,interaction, and completion of necessary paper concise procedure manuals for all be-Prioritization work. policies. These policies must by delineated work areas, be it Each laboratory hasexamples eachor ofpersonal digital Some known to numbermedical division, ideal include a processes that areanlaboratory, employee. made performed in the- Accountability assistant (PDA), a day planner, or an online laboratory. As with policies, the book of specialty. employees based upon the number of success procedurescalendar.-Measuring laboratoryit handles and the level of specimens that should be continuouslyin the laboratory.LABORATORY automation updated by a team manager A of experts. The standard operating procedures (SOP) must ensure that efficient staffing is MANAGER manual is a very important tool in the maintained. laboratory. An up-to-date SOP ensures that procedures performed by the technical DIRECTING staff are consistent and of the highest CONTROLLING- Communicating quality. - Evaluating Performance- Delegating - Decision making- Motivating- Coaching
  93. 93. PLANNING ORGANIZING-Selecting a planning group - Time management- Environmental analysis - Organization chart- SWOT analysis -Policies- Vision and Mission statements - Procedures- Goals, Objectives & strategies - Staffing and scheduling-Prioritization- Accountability-Measuring success Directing is the process of LABORATORY influencing people to MANAGER attain Some Delegation is theof pre-basic attributes process of selecting to determined objectives. Employees require motivation in order quality communicationlimited pool (current people from a very consistently give their best effort. Motivation includeincumbents) to perform a task. It iscoaches, job attention, ac-andare teachers and The best managers DIRECTING to give externally derived. is both internally ceptance, and empathy. the employees a in a CONTROLLING important engaging their employees always Every individual has professional strengths- Communicating productive andempowerment. of continuing feeling of ongoing process- Evaluating Performance and limitations, activities that they find- Delegating education. Many employeesDecisionactive, - require exciting and tasks that are drudgery. making- Motivating hands-on development to realize the best of their abilities.- Coaching
  94. 94. PLANNING ORGANIZING-Selecting a planning group - Time management- Environmental analysis - Organization chart- SWOT analysis -Policies- Vision and Mission statements - Procedures- Goals, Objectives & strategies - Staffing and scheduling-Prioritization A probationary period, usually 6 months of- Accountability Controlling is the process or 1 year in duration fromthat everything is going the time of hire,-Measuring success determining is the time when the manager should be must according to plan. A manager When presented with aLABORATORY constantly and big decision critically observant of performance. The review con- sistently makingperformance appraisal isin the purpose of a opportunity, it situation to the current is often MANAGER provide thewrite downwithproblemthere are helpful to employee the written laboratory to ensure that and make a listhe or she is pro- no of possible feedback about howunattended details. solutions, intended outcomes, and gressing toward specific employment DIRECTING potential problems. Most objectives. CONTROLLING- Communicating importantly, never panic - Evaluating Performance- Delegating - Decision making- Motivating- Coaching
  95. 95. • The technical aspects of running a laboratory are codified and tightly regulated. When technical problems arise, there is very often a manual to help guide the solution.• When it comes to managing the human side of the laboratory, there are daily challenges for which there are no obvious solutions.• There does exist, however, a set of time-tested management tools for use by laboratory managers in addressing these daily challenges.• A laboratory manager must become familiar with these tools and use them on a daily basis to gain confidence and experience in managing the human side of the laboratory.
  96. 96. SOURCE• http://labmed.ascpjournals.org/conten t/37/7/397.short
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