Working in the laboratory

Dr Varsha Shahane

Objectives

• To ensure and assure quality• Ethical practices• Waste management• Care of lab equipments

Contents

• Good lab practices• Ethics in lab medicine• BMW• Equipments

Good laboratory practices (GLP)

Why do we need GLP ?

• Poorly trained personnel• Poorly designed and poorly followed

protocols• Data collection- poor, not verified, not

traceable• Inadequate sources• Equipment not calibrated• Reports not verified

Principles of GLP

• To implement clear organisation structures• To help scientists obtain results which are – reliable,

repeatable, auditable, recognised by scientists all over the world

• Helps in standardization of tests – avoid false positives and false negatives

GLP ensures that studies are :

• Planned• Performed ( SOPM)• Recorded• Reported• Archived- stored/ preserved • Monitored

Laboratory Accreditation

• Third party certification of competence of medical laboratory

• It is a formal recognition of the labs where people are reassured of the reliability of the lab services

• National Accreditation Board for Testing and Calibration laboratories – NABL- to perform tests in accordance with ISO guidelines

Benefits of Accreditation

• Enhances customer confidence- potential increase in business

• International level of competence achieved• Time, money, effort saved – repetition of tests and re

testing of reagents avoided• Better control of lab operations• Lab personnel more confident about their reports• Better networking and access to remote patients

To summarize :

• Limits wastage and resources• Ensures high quality• Ensures comparability of results• Promotes mutual recognition of results

IT IS THE QUALITY SYSTEM FORMANAGEMENT OF WORK

Ethics in Laboratory Medicine

• Newer genetic and advanced biochemical techniques ↔ increasing workload, increased need for skilled

personnel → professional and medical ethics !

Community concerns

• Privacy• Informed consent• Access to information• Retention of samples and information

Main aim :

• Uphold the reputation of their profession• Benefit the health and well being of patients and

community → welfare and interest of patients• Treat all patients equally, no discrimination• Collect only relevant and necessary information of

patient required to carry out the test/tests. Explain the purpose to patient

• In case of communicable diseases, safety of staff and other patients should be given priority

Ethics in pre-examination

• Informed consent- for invasive or risky procedures• In cases of diseases with serious implications, like,

genetic diseases, HIV etc, adequate counselling is important prior to collection of sample

• During reception and sample collection adequate privacy for the patient should be ensured

• If the sample received is unacceptable for testing, it should be discarded and the concerned physician be notified.

Ethics in examination

• Examination of the sample be performed by the skilled personnel only

• Only standard procedures should be followed for collection, transport, testing and reporting of results – all documented in SOPM (standard operating manual)

• Tampering with results / fabrication of results.... X• If an in house procedure is used, it must be validated

and documented• Use adequate controls during test. External and

internal QC has an important role

Ethics in post examination

• Results should be documented and verified by the chief of the lab

• Undue delay in reporting should be avoided and if it is inevitable, the concerned physician should be informed about the delay with reasons

• Confidentiality of report is of utmost importance- inform only the physician

• Results if used for epidemiology or statistical data, should be done without disclosing the patient’s identity

• Accurate interpretation of results is crucial in the interests of the patient

Lab records

• Record section –identification, collection , indexing, access, storage, maintainence and safe disposal of records

• Safety (loss, unauthorised access, tampering, damage, misuse)

• Legibility and readability• Retrievable• Duration of retention of records to be defined

• Accessibility to lab records- Develop protocols to handle requests that deal with gaining access to record section

• Access should be through requesting physician, lab staff, duty of other individuals ( police, scientists etc)

Biomedical waste management (BMW)

• It is defined as any waste which is generated during diagnosis, treatment or immunization of human beings or animals or in research activities or in testing or production of biological specimens

• Dangers – infections (Tb, pneumonia, diarrhoeal diseases), re sale and re use (Hepatitis B and C, HIV), injuries, toxic effects

AIR, WATER and LAND POLLUTION

Categorisation of waste

• Non hazardous – 85% General : wrapping paper, cartons, stationery,

plastic sheets Kitchen : bio degradable (fruit and vegetable peels,

leftover food, tea etc) and non bio degradable (wrapping, foils, plastic bag)

BIO HAZARD SYMBOL →

• Hazardous – 15%

Infectious : dressings, swabs, samples, syringes, needles, sharps, liquid waste from washing and housekeeping etc

Toxic : (i) chemical – during storage, transport and disposal (ii) pharmaceutical –due to surplus stock or spillage (iii) radioactive waste – analytical, procedures, imaging

Waste audit

• Type and quantity of waste generated, planning of policy

• Daily inspection of kitchen, OT, pharmacy, wards, pre op rooms, emergency wards, OPDs, injection and dressing rooms

BMW management

• Segregation at point of generation• All the segregated waste should be placed in a

puncture proof plastic bag which should go in the correct colour coded container with a lid

• The workers should use all personal protective measures while cleaning, collecting and segregation of BMW, including getting vaccinated

Colour coding system of infectious waste

Colour coded containers

Methods to treat BMW

• Mechanical : grinding, compressing, shredding, pulping

• Thermal : Incineration, steam, electromagnetic radiation, combustion, high temperature plasma

↓ BOTH – aim at reducing the volume of waste and

then sterilising it

• Important things to remember :• Needle re capping must be strictly prohibited. Needle

sterlisers and cutters used• Segregate waste at the point of production. Every

room must have colour coded bags for disposal• Strictly adhere to colour coding• NEVER allow infectious and non infectious waste to

mix• NEVER transport infectious waste with the general

municipal waste. Arrange separate transport for biohazard waste

• The containers should not be filled upto the brim. Only 3/4th of it should occupy the waste

• The plastic bags should be tied tightly before placing in container

• Use chemical disinfectants for pre treatment of BMW before placing in container– sodium hypochlorite (0.5-5%)

• Strictly follow personal protective measures guidelines and the hospital policies

• REDUCE, RE USE , RECYCLE

• Care and Use of instruments Laboratory testing needs to be – fast, reliable, accurate, cost effectiveSo good quality instruments are required and they should be properly used and taken care of

• Microscope, pH meter, autoclaves, hot air ovens, centrifuges, pipettes, analytical balance, automatic dispensers and diluters, thermometers, glassware, plastic ware, bilogical safety cabinets, refrigerators, incubators, freezers,ELISA readers, waterbaths, spectrophotometers, auto analyser, distilled water plants, diagnostic kits, reagents

General Do s and Don’t s

• Keep all equipment away from heat, strong light, powerful electrical connections, water prone areas. Keep in cool dry places

• Daily / periodic cleaning and calibration. Also, daily checking of the working part of each instrument

• Use of correct cleaning agents, solvents etc• Proper storage of every part of the equipment • Maintainence – Annual maintainence contract (AMC)

contd

• Proper procedures of switching on , switching off and placing the instruments

• Gentle and careful use • STRICT ADHERENCE TO THE INSTRUCTIONS GIVEN

IN THE MANUAL FOR EVERY EQUIPMENT AND INSTRUMENT IN THE LAB.

Be alert. Love your lab and take care of it.