ihmr-bangalore compiled by dr ratnesh pandey

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IHMR-Bangalore Compiled By Dr Ratnesh Pandey 3 M LABORATORY SERVICES

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IHMR-Bangalore Compiled By Dr Ratnesh Pandey. 3 M LABORATORY SERVICES. 3 M LABORATORY SERVICES MANAGING MONITORING & MASTERING. Outline. Introduction Defining Lab & Lab Services Types of Lab Lab Services Importance of Lab Services Lab Equipment Lab Information System Lab Services - PowerPoint PPT Presentation

TRANSCRIPT

Page 1: IHMR-Bangalore Compiled By Dr Ratnesh Pandey

IHMR-Bangalore

Compiled ByDr Ratnesh Pandey

3 M LABORATORY SERVICES

Page 2: IHMR-Bangalore Compiled By Dr Ratnesh Pandey

• 3 M LABORATORY SERVICES• MANAGING• MONITORING &• MASTERING

Page 3: IHMR-Bangalore Compiled By Dr Ratnesh Pandey

Outline Introduction Defining Lab & Lab

Services Types of Lab Lab Services Importance of Lab

Services Lab Equipment Lab Information System Lab Services Lab Medicines

Lab Safety Planning Staffing NABL Research & Training Policies Procedures Role of Administration Conclusion 

Page 4: IHMR-Bangalore Compiled By Dr Ratnesh Pandey

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

Page 5: IHMR-Bangalore Compiled By Dr Ratnesh Pandey

Medical Laboratories

Clinical Pathology Clinical Microbiology Clinical Biochemistry

Haematology

Histopathology

Cytology

Routine Pathology

Bacteriology

Mycobacteriology

Virology Mycology

Parasitology

Immunology

Serology

Biochemical analysis

Hormonal assays

Page 6: IHMR-Bangalore Compiled By Dr Ratnesh Pandey

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

Page 7: IHMR-Bangalore Compiled By Dr Ratnesh Pandey

Services we provide..

• Microbiology

• Parasitology

• Virology

• Haematology

• Coagulation

• Clinical Biochemistry

• Toxicology

• Immunohaematology/Blood bank

Page 8: IHMR-Bangalore Compiled By Dr Ratnesh Pandey

• Urinalysis

• Histopathology

• Cytopathology

• Electron microscopy

• Genetics

• Cytogenetics

• Surgical pathology

• Immunology/Serology

Page 9: IHMR-Bangalore Compiled By Dr Ratnesh Pandey

Lab equipments and LIS

Page 10: IHMR-Bangalore Compiled By Dr Ratnesh Pandey

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

Page 11: IHMR-Bangalore Compiled By Dr Ratnesh Pandey

Following element should be considered during 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

Page 12: IHMR-Bangalore Compiled By Dr Ratnesh Pandey

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 solution

2) 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 top

3) 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

Page 13: IHMR-Bangalore Compiled By Dr Ratnesh Pandey

Continued………………………….4) Microscope- Mono Ocular/binocular:Is an instrument used to see objects that are too small for the naked eye

5) Hot air oven: Are electrical devices used in sterilization

6) Autoclave:Is a device used to sterilize equipment and supplies by subjecting them to high pressure saturated steam at 121 °C for around 15–20 minutes depending on the size of the loads

7) Ph-meter:  is an electronic instrument used for measuring the pH (acidity or alkalinity) of a liquid

Page 14: IHMR-Bangalore Compiled By Dr Ratnesh Pandey

Lab equipments

8) Incubator: Is a device used to grow and maintain of course  microbiological cultures or cell cultures

9) Automated biochemistry analyzer: Is an instrument designed to measure different

chemicals and other characteristics in a number of biological samples quickly, with minimal humanassistance

11) 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

Page 15: IHMR-Bangalore Compiled By Dr Ratnesh Pandey

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 radiation

14) 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 contents

15) Hot plate:A hot plate is a portable self-contained tabletop small appliance that features one, two or more gas burners or electric heating elements

Page 16: IHMR-Bangalore Compiled By Dr Ratnesh Pandey

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

Page 17: IHMR-Bangalore Compiled By Dr Ratnesh Pandey

Lab information system

Page 18: IHMR-Bangalore Compiled By Dr Ratnesh Pandey

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.

Page 19: IHMR-Bangalore Compiled By Dr Ratnesh Pandey

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

Page 20: IHMR-Bangalore Compiled By Dr Ratnesh Pandey

Benefits of Lab Information System

Doctors• The lab results of critical patients would be notified instantaneously to the

doctor• All the lab results would be submitted directly to the doctor

Patients• 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 lab

Lab Technician• Immediate receipt of the doctors’ orders to perform a lab test• Easier reporting of lab results of the patients

Page 21: IHMR-Bangalore Compiled By Dr Ratnesh Pandey

The functional components of the clinical Laboratory

Page 22: IHMR-Bangalore Compiled By Dr Ratnesh Pandey

FUNCTIONS OF THECLINICAL 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

Page 23: IHMR-Bangalore Compiled By Dr Ratnesh Pandey

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

Page 24: IHMR-Bangalore Compiled By Dr Ratnesh Pandey

Hematology • Hematology :-The study of blood. This

section counts and qualifies the different types of blood cells and other components found in blood

Page 25: IHMR-Bangalore Compiled By Dr Ratnesh Pandey

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

Page 26: IHMR-Bangalore Compiled By Dr Ratnesh Pandey

Clinical Chemistry/Biochemistry

• Chemistry - Performs most chemical analyses including glucose, sodium, potassium, and cholesterol.

Page 27: IHMR-Bangalore Compiled By Dr Ratnesh Pandey

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)

Page 28: IHMR-Bangalore Compiled By Dr Ratnesh Pandey

Microbiology• Microbiology - The study of

microorganisms, including viruses, that can only be seen with a microscope.

Page 29: IHMR-Bangalore Compiled By Dr Ratnesh Pandey

Blood Bank• Blood Bank - Collects, tests, types and

stores blood donations used for blood transfusions

Page 30: IHMR-Bangalore Compiled By Dr Ratnesh Pandey

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

Page 31: IHMR-Bangalore Compiled By Dr Ratnesh Pandey

Lab Safety and Rules of the Lab

Page 32: IHMR-Bangalore Compiled By Dr Ratnesh Pandey

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

Page 33: IHMR-Bangalore Compiled By Dr Ratnesh Pandey

Protect YourselfEye Safety

• Wear safety goggles when working with chemicals, flames, or heating devices

• If you wear contact lenses let your boss or teacher know

Page 34: IHMR-Bangalore Compiled By Dr Ratnesh Pandey

Eye Safety• In case of emergency in

which a chemical goes into one’s eye, use the eyewash station

• Flush in water for 15 mins. and notify the teacher

Page 39: IHMR-Bangalore Compiled By Dr Ratnesh Pandey

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

Page 40: IHMR-Bangalore Compiled By Dr Ratnesh Pandey

Heating Safety • Tie back hair and loose

clothes when workingwith 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

Page 41: IHMR-Bangalore Compiled By Dr Ratnesh Pandey

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

Page 42: IHMR-Bangalore Compiled By Dr Ratnesh Pandey

Chemical Safety

• Read all labels twice before removing a chemical from the container

• Only use the type and amount of chemicalinstructed to use

• Never touch, taste, or smell a chemical unless instructed by the teacher

• Never mix chemicals unless instructed to do so

Page 43: IHMR-Bangalore Compiled By Dr Ratnesh Pandey

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

Page 44: IHMR-Bangalore Compiled By Dr Ratnesh Pandey

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

Page 45: IHMR-Bangalore Compiled By Dr Ratnesh Pandey

Continued…• Eat or drink in the lab• Use lab glass-ware to

eat or drink out of

Page 46: IHMR-Bangalore Compiled By Dr Ratnesh Pandey

• Engage in….– practical jokes – horse play – rough house

Continued…

Page 47: IHMR-Bangalore Compiled By Dr Ratnesh Pandey

In case of an emergency…

• Know the locations of:– fire extinguisher– fire blanket– body shower– eyewash

station– first aid kit

Page 48: IHMR-Bangalore Compiled By Dr Ratnesh Pandey

In case of an emergency…

• Know the locations of:– fire extinguisher– fire blanket– body shower– eyewash

station– first aid kit

Page 49: IHMR-Bangalore Compiled By Dr Ratnesh Pandey

In case of an emergency…

• Know the locations of:– fire extinguisher– fire blanket– body shower– eyewash

station– first aid kit

Page 50: IHMR-Bangalore Compiled By Dr Ratnesh Pandey

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

Page 52: IHMR-Bangalore Compiled By Dr Ratnesh Pandey

Planning for laboratory services

Page 53: IHMR-Bangalore Compiled By Dr Ratnesh Pandey

Facility design ProcessStages activities

Situation 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

Page 54: IHMR-Bangalore Compiled By Dr Ratnesh Pandey

The planning of laboratory services depends on following

factors:-

Planning

Equipment and Facilities

Manpower

Infrastructure and work Place

Page 55: IHMR-Bangalore Compiled By Dr Ratnesh Pandey

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 sections

2) 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)

Page 56: IHMR-Bangalore Compiled By Dr Ratnesh Pandey

Infrastructure Planning

Infrastructure

Location

ADMN area

Functional area

Auxiliary Area

Environmental consideration

Size

Ancillary Area

Page 57: IHMR-Bangalore Compiled By Dr Ratnesh Pandey

Central Lab unit1) Administrative area:-• Office of pathologist•Record room•Administration Office•Patient Waiting Area•Seminar room

2)Auxillary Area:-•Glass washing room•Cleaning of Instrument•Equipment sterilization

3) Ancillary Area:-•Treatment and disposal of specimens•Janitors room•Chemical and reagent store

Page 58: IHMR-Bangalore Compiled By Dr Ratnesh Pandey

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

Page 59: IHMR-Bangalore Compiled By Dr Ratnesh Pandey

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

Page 60: IHMR-Bangalore Compiled By Dr Ratnesh Pandey

Suggested dimensions for interiorLaboratory counter width 2feet 6 inches

Laboratory counter to wall clearance 4 feet

Laboratory counter to counter clearance 7 feet

Desk height 30 inches

Keyboard drawer height 25-27 inches

Human body standing 4 square feet

Human body sitting 6 square feet

Desk space 3 square feet

Page 61: IHMR-Bangalore Compiled By Dr Ratnesh Pandey

Floor PlanH AEMATOLOGy

Urinolysis

Biochemist

ry

Biochemistry

Histolpathology

Serology Bacterio

logy

Ancillary Area

Venipuncture cubicle

Exam and Test

Pathologist office

Record room

Administrative office

Waiting Area

Sterilization Glass Washing

And Cleaning

Tech Lockers

Tech Toilet

Page 62: IHMR-Bangalore Compiled By Dr Ratnesh Pandey

Space Utilization Chart (Rules of Thumb)

Page 63: IHMR-Bangalore Compiled By Dr Ratnesh Pandey

Infrastructure costing1 unit (land requirement) 200sqr feet

8 functional unit 1600 sqr feet

rest 1600 sqr feet

total 3200sqr feet

Rate of land per sqr feet 2500(Rs.)

Total cost 80,00000

Extra expendicture 20,0000

Total land cost 1cr

Cost of construction+interior 75 ,00000

Total sum 1.75cr

Page 64: IHMR-Bangalore Compiled By Dr Ratnesh Pandey

Lab equipment costingEquipment Cost (Rs.)Colorimeter 25,000

Centrifuge 20,000

Water Bath 10,000

Electronic Microscope 3,25,000

Hot air oven 39,330

Incubator 1,30,000

Ph-meter 20,000

Automated biochemistry analyzer 2,00,000

Enzyme-linked immunosorbent assay(ELISA) -Reader

50,000

Others 200000

Reagents 70,000-80,000

Budget (per unit) 20,00,000

Total budget (8 units) 1.60 cr

Page 65: IHMR-Bangalore Compiled By Dr Ratnesh Pandey
Page 66: IHMR-Bangalore Compiled By Dr Ratnesh Pandey

Activity PlanningFrom Different

Hospital

PatientsRegistration

Sample collection

Testing

Lab Management System

Sample analysis Quality Control

Result

Reporting

Impression

Page 67: IHMR-Bangalore Compiled By Dr Ratnesh Pandey

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

Page 68: IHMR-Bangalore Compiled By Dr Ratnesh Pandey

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

Page 69: IHMR-Bangalore Compiled By Dr Ratnesh Pandey

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

Page 70: IHMR-Bangalore Compiled By Dr Ratnesh Pandey

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

Page 71: IHMR-Bangalore Compiled By Dr Ratnesh Pandey

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

Page 72: IHMR-Bangalore Compiled By Dr Ratnesh Pandey

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

Page 73: IHMR-Bangalore Compiled By Dr Ratnesh Pandey

CONTD…• NABL Accreditation is currently given

in the following fields:

TESTI

NG

LABS

• Biological

• Chemical

• Electrical

• Electronics

• Fluid-Flow

• Mechanical

• Non-Destructive

• Photometry

• Radiological

• Thermal

CALI

BRATION

LABS

• Electro-Technical

• Mechanical

• Fluid Flow

• Thermal & Optical

• Radiological

ME

DIC

AL LABS

• Clinical Biochemistry

• Clinical Pathology

• Hematology and Immunohaematology

• Microbiology and Serology

• Histopathology

• Cytopathology

• Genetics

• Nuclear Medicine

Page 74: IHMR-Bangalore Compiled By Dr Ratnesh Pandey

A qualified individual is responsible for managing the laboratory service

Page 75: IHMR-Bangalore Compiled By Dr Ratnesh Pandey

Responsibilities for managing the laboratory services

It 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

Page 76: IHMR-Bangalore Compiled By Dr Ratnesh Pandey

An individual with adequate training, skills, orientation and experience administer tests

and interpret the results.

Page 77: IHMR-Bangalore Compiled By Dr Ratnesh Pandey

For the laboratory services, is it sufficient that the laboratory director meets the

experience, education and training requirements???

Page 78: IHMR-Bangalore Compiled By Dr Ratnesh Pandey

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.

Page 79: IHMR-Bangalore Compiled By Dr Ratnesh Pandey

As per CLIA,

Laboratory Director must ensure that: the pre-analytic, analytic and post-analytic phases of testing are appropriate for the patientsphysical and environment conditions of the laboratory are adequate and appropriate for the testing performeda general supervisor is available to provide day-to-day supervision of all testing personnel each employee’s responsibilities and duties are specified in writing

Page 80: IHMR-Bangalore Compiled By Dr Ratnesh Pandey

Personnel positions

Moderate Complexity testing

Technical consultant Clinical consultant Testing personnel

High complexity testing

Technical supervisorClinical consultantGeneral supervisorTesting personnel

Page 81: IHMR-Bangalore Compiled By Dr Ratnesh Pandey
Page 82: IHMR-Bangalore Compiled By Dr Ratnesh Pandey
Page 83: IHMR-Bangalore Compiled By Dr Ratnesh Pandey

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

Page 84: IHMR-Bangalore Compiled By Dr Ratnesh Pandey

Procedures

Processes

Policies

Page 85: IHMR-Bangalore Compiled By Dr Ratnesh Pandey

General Standards

• Hours• Meetings/Communications• Specimen Handling• Specimen Storage• Panic Values• Reference Ranges• Lab Errors• Lab Results• Reportable Diseases• Patient Identifiers

Page 86: IHMR-Bangalore Compiled By Dr Ratnesh Pandey

In House & Reference Lab Specimen Labelling andSpecimen Collection Procedures

• “Routine” Specimens• Urine• Gynaecological Specimens• Blood Collection, Finger Stick and

Phlebotomy• Stool Occult Blood/O&P/C&S• Lab Specimen Containers

Page 87: IHMR-Bangalore Compiled By Dr Ratnesh Pandey

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

Page 88: IHMR-Bangalore Compiled By Dr Ratnesh Pandey

• Patient Complaints• Personnel Responsibilities/Job Description• Reporting of Communicable Diseases

Page 89: IHMR-Bangalore Compiled By Dr Ratnesh Pandey

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

Page 90: IHMR-Bangalore Compiled By Dr Ratnesh Pandey

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.

Page 91: IHMR-Bangalore Compiled By Dr Ratnesh Pandey

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

Page 92: IHMR-Bangalore Compiled By Dr Ratnesh Pandey

Billing and Reporting

• Online by accessing our site• Via mail• Massage on mobile • Letter • Via Telephone • Customer care

Page 93: IHMR-Bangalore Compiled By Dr Ratnesh Pandey

ROLE OF ADMINISTRATOR IN LABORATORY SERVICES

Page 94: IHMR-Bangalore Compiled By Dr Ratnesh Pandey

LABORATORY MANAGER??

• A laboratory manager is a uniquely skilled employee with a very high level of daily responsibility that spans all areas of the organization

They are “extenders” of the physician directors.

Page 95: IHMR-Bangalore Compiled By Dr Ratnesh Pandey

PLANNING-Selecting a planning group- Environmental analysis- SWOT analysis- Vision and Mission statements- Goals, Objectives & strategies-Prioritization- Accountability-Measuring success

ORGANIZING- Time management- Organization chart-Policies- Procedures- Staffing and scheduling

DIRECTING- Communicating- Delegating- Motivating- Coaching

CONTROLLING- Evaluating Performance- Decision making

LABORATORY MANAGER

The objective of planning is to set an achievable course of action by

establishing an environment where day-to-day activi-ties are well-controlled,

measurable, and thoroughly understood by employees at every level of the

organization.

A knowledgeable and motivated group from within the laboratory should be assembled to create and administer a

strategic plan. This group must include key people from all functional areas.

An environmental analysis is a systematic review of the internal and

external factors that influence the operation of the laboratory. A vision statement sets an articulate visualization of

what the organization seeks to become at some point. A mission statement answers certain fundamental questions about the organization, such as “What is our purpose?” “In what activities will we be engaged in order to ac-

complish that purpose?”

A practical implementation timeline should be developed. For most modern medical laboratories, a planning horizon

of 18 months to 2 years is practical.

It is necessary to assign priorities by weighing the importance of the tasks at hand to determine which have

the highest level of immediate precedence. Therefore, planning is often a struggle between “must do” and “want

to do” decisions.

A plan must have built-in accountability. This amounts to assigning a specific individual to be

responsible for each action item to ensure follow-through.

A regular reporting mechanism must be established to review progress on action items and to monitor changes in environment. Monthly, or perhaps even weekly, meetings should be scheduled to discuss

progress toward stated goals and objectives.

Page 96: IHMR-Bangalore Compiled By Dr Ratnesh Pandey

PLANNING-Selecting a planning group- Environmental analysis- SWOT analysis- Vision and Mission statements- Goals, Objectives & strategies-Prioritization- Accountability-Measuring success

ORGANIZING- Time management- Organization chart-Policies- Procedures- Staffing and scheduling

DIRECTING- Communicating- Delegating- Motivating- Coaching

CONTROLLING- Evaluating Performance- Decision making

LABORATORY MANAGER

A key management task is to organize the activities of the

laboratory in such a way that effort and expenditures are mini- mized

and output is maximized.

In all circumstances, a manager should set and adhere to a reasonable schedule, building enough

time into the day for essential meetings, interaction, and completion of necessary paper work. Some examples include a personal digital

assistant (PDA), a day planner, or an online calendar.

An organizational chart helps to clarify workflow, reporting lines, and areas of

responsibility by explicitly listing delineated work areas, be it by division, laboratory, or medical

specialty.

Policies are “Laws” of laboratories. understand set of policies. These policies must be

made known to each employee.

A laboratory manager must maintain current, concise procedure manuals for all

processes that are performed in the laboratory. As with policies, the book of

laboratory procedures should becontinuously updated by a team of experts. The standard operating procedures (SOP)

manual is a very important tool in the laboratory. An up-to-date SOP ensures that

procedures performed by the technical staff are consistent and of the highest

quality.

Each laboratory has an ideal number of employees based upon the number of

specimens that it handles and the level of automation in the laboratory. A manager

must ensure that efficient staffing is maintained.

Page 97: IHMR-Bangalore Compiled By Dr Ratnesh Pandey

PLANNING-Selecting a planning group- Environmental analysis- SWOT analysis- Vision and Mission statements- Goals, Objectives & strategies-Prioritization- Accountability-Measuring success

ORGANIZING- Time management- Organization chart-Policies- Procedures- Staffing and scheduling

DIRECTING- Communicating- Delegating- Motivating- Coaching

CONTROLLING- Evaluating Performance- Decision making

LABORATORY MANAGER

Directing is the process of influencing people to attain pre- determined objectives.Some basic attributes of

quality communication include attention, ac-

ceptance, and empathy.

Delegation is the process of selecting people from a very limited pool (current job incumbents) to perform a task. It is

important to give the employees a feeling of empowerment.

Employees require motivation in order to consistently give their best effort. Motivation

is both internally and externally derived. Every individual has professional strengths

and limitations, activities that they find exciting and tasks that are drudgery.

The best managers are teachers and coaches, always engaging their employees in a

productive and ongoing process of continuing education. Many employees require active,

hands-on development to realize the best of their abilities.

Page 98: IHMR-Bangalore Compiled By Dr Ratnesh Pandey

PLANNING-Selecting a planning group- Environmental analysis- SWOT analysis- Vision and Mission statements- Goals, Objectives & strategies-Prioritization- Accountability-Measuring success

ORGANIZING- Time management- Organization chart-Policies- Procedures- Staffing and scheduling

DIRECTING- Communicating- Delegating- Motivating- Coaching

CONTROLLING- Evaluating Performance- Decision making

LABORATORY MANAGER

Controlling is the process of determining that everything is going according to plan. A manager must constantly and con- sistently review

the current situation in the laboratory to ensure that there are

no unattended details.

A probationary period, usually 6 months or 1 year in duration from the time of hire, is the time when the manager should be critically observant of performance. The purpose of a performance appraisal is to

provide the employee with written feedback about how he or she is pro- gressing toward specific employment

objectives.

When presented with a big decision making opportunity, it is often

helpful to write down the problem and make a list of possible

solutions, intended outcomes, and potential problems. Most importantly, never panic

Page 99: IHMR-Bangalore Compiled By Dr Ratnesh Pandey

• 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.

Page 100: IHMR-Bangalore Compiled By Dr Ratnesh Pandey

• http://labmed.ascpjournals.org/content/37/7/397.short

SOURCE

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Page 102: IHMR-Bangalore Compiled By Dr Ratnesh Pandey

Thanks