quality assurance

1. Quality improvement of Laboratory Services
In Chhattisgarh
Dr. Sanjay Singh Negi
Assistant Professor
Department of Microbiology
AIIMS, Raipur, C.G.

2. Chhattisgarh
Disease prevalent in
chhattisgarh
 Tuberculosis
 HIV
 Leprosy
 Sickle cell anemia
 Water borne disease of
bacterial, viral and
parasitic nature
 Parasitic disease
 Fungal infection

3. Importance of Laboratory
diagnosis in management of the
diseases

4. Microscopy
Wet mount
Fungal infection
Parasites
Protozoal cyst & trophozoites Entamoeba histolytica
Naegleria, Acanthamoeba
Flagellates Giardia, Trichomonas
Sporozoa Cryptosporidium parvum
Helminthes Helminth egg & larvae

5. Staining & Microscopy
 Gram Staining
 Acid fast staining
 Albert staining
 Peripheral blood smear
 LPCB

6. Serological tests

7. Major bottleneck issues seen in
Laboratory

8. Indirect
 More empirical treatment/Paying less importance to laboratory
diagnostic services.
Doctors Laboratory diagnosis • Proper management
of patients.
• Prevention of spread
/ outbreak
• Saving of economy.
Patients
Patients Doctors
• Empirical treatment .
• Half chance of failure of
treatment.
• Menace of Drug resistance
• Spread of infection in
family/community leading
to outbreak/ epidemic
• Loss of economy.
 Lack of information / coordination between doctors and laboratory
supervisor.

9. Appropriate use of laboratory
investigation
Collaboration between
Clinician
&
laboratory personnel
Gaps needs to filled up

10. 21st Century MEDICAL CARE
becomes Comprehensive
only with the support
Of
BASIC LABORATORY FACILITIES
Shifting of Paradigm
from
symptomatic treatment
To
evidence based practice of medicine.

11. Direct
 Insufficient number/Overburdened medical personnel.
 Insufficient number of laboratory staff.
 Half hearted approach of laboratory staff towards their work.
 Multiple reason.
• Improper supply of equipments & consumables.
• Administrative blockage/ lengthy purchase procedure/ unclear purchase norms.
• No update on the recent development in the diagnostic fields/tests.
• Unaccountability/Less attention
• No appreciation/ promotion for hard & sincere workers.
• Inadequate salary.
 User fee for diagnostic services (Biggest challenge for the poor
people to approach laboratory even if prescribed by the doctor
Few patient turned up to laboratory

12.  No reporting mechanism
 Lack of quality management
 No internal and external quality assurance programs.
 Lack of knowledge of documentation of tests performed/ record/
standard operating procedure(SOP)/ Flow chart.

13. Laboratory investigations
are important
in
the diagnosis, treatment, and surveillance of both
communicable(infectious) diseases
&
non communicable diseases
&
the selection and use of antimicrobial and other drugs for
early and effective treatment.
It is, therefore, essential that test reports are
relevant, reliable, timely, and interpreted
correctly.
Quality improvement in laboratory

15. •Consistency
– Accuracy
– Precision
•Right result
– First time
– Every time
Quality…….

16. • Support provision of high quality health-
care
– Reduce morbidity
– Reduce mortality
– Reduce economic loss
• Ensure credibility of lab
• Generate confidence in lab results
Objectives of quality in lab

17. Consequences of poor quality
• Inappropriate action
– Over-investigation
– Over-treatment
– Mistreatment
• Inappropriate inaction
– Lack of investigation
– No treatment
• Delayed action
• Loss of credibility of laboratory
• Legal action

18. Quality assurance(QA) Defined by WHO
“ The total process whereby the quality of laboratory reports can be
guaranteed.”
It has been summarized as the:
right result,
at the right time,
on the right specimen,
from the right patient,
with the result interpretation based on correct reference data,
and at the right price.
Quality control(QC)
Cover the part of QA primarily concerning with the control of errors in the
performance of tests and verification of tests results.

19. Quality assurance
Internal quality control + External quality assessment
Continuously &
concurrently assessing
lab work
Retrospectif and
periodic

21. Standard Operating Procedure(SOP)
Each laboratory must have SOPs.
It is required for the following reasons:
 To improve and maintain the quality of laboratory service to patients and identify
problems associated with poor work performance.
 To provide laboratory staff with written instructions on how to perform tests
consistently to an acceptable standard in the laboratory.
 To help avoid short-cuts being taken when performing tests.
 To provide written standardized techniques for use in the training of laboratory
personnel.
 To facilitate preparation of list & inventory of reagents, chemicals & equipment.
 To promote safe laboratory practice.

22. Preparation of SOP
SOP must be written and
implemented to maintain QA.
Each SOP must be given a title and
identification number and be dated
and signed by an authorized
person.
ISO 15189:2012.
Medical laboratories--Particular
requirements for quality and
competence, provides a
framework for the design and
improvement of process-based
quality management systems by
medical laboratories.

23. Template of SOP

24. Template of SOP

25. Template of SOP

26. Template of SOP

27. Template of SOP

28. Specimen must be accompanied by a request form which
contains the following information’s:
 Patient's name, age, gender, occupation, outpatient or
inpatient number, ward or health center.
 Type and source of specimen, date and time of collection.
 Investigation(s) required.
 Clinical note summarizing the patient's illness, suspected
diagnosis and information on any antimicrobial treatment
that may have been started at home or in the hospital.
 Name of medical officer requesting the investigation.
Request form
Pre analytic stage

29. Request form at AIIMS, Raipur

30. Request form at AIIMS, Raipur

31. Sample collection and handling
Key to Full Proof Diagnosis
• Specimen such as urine and sputum are best collected
soon after a patient wakes up.
• Blood is best collected when a patients temperature
begins to rise.
• Every efforts must be made to collect specimens for
microbiological investigation before antimicrobial
treatment.
• Proper storage of samples in case of delay of
processing.
• CSF, other body fluids, swabs not in transport media
or faecal specimen containing blood and mucus
requires immediate processing.
• Saliva instead of sputum, dry faecal swab, eye swab
and any leaking specimen are not acceptable.

32. SOP and its implementation must be ensured.
1. Detailed procedure for examining different specimens/
infectious disease/ tests.
2. Staining techniques and QC of stains.
3. Reading and interpretation of different tests
4. Cleaning and QC of equipment used in the laboratory
5. Immunologic technique & QC of Ag and Ab reagents
6. Safe working practices
7. Disposal of specimens , used kits, testing material and
other waste.
8. Safe working practices.
9. Cleaning of glassware, plastic ware etc.
10.Sterilization procedure and their control.
Analytical stage

33. QC of stains & reagents
 Whenever new stain is used a control
smear should be used and examined.

34. Reporting results
• Format used in reporting should be standardized and agreed b/w laboratory
personnel and clinicians.
• Any preliminary report must be followed by a full written report.
• All report must be checked for correctness and clarity.
• It must be signed by the laboratory technician and Microbiologist / Pathologists.
Post analytical stage

35. Factors influencing quality: Post-analytical
• Right recording and reporting
• Right interpretation
– Range of normal values
• Right turnaround time
• Report to right user

36. Reporting results

37. Internal Quality assessment(IQA)
 Set of procedures undertaken by the staff to
ensure quality of reports
 Total process beginning with sample collection
up to final reporting.
 Each laboratory should have an internal
quality assessment scheme.
 Regular use of internal positive and negative
controls for the tests and controls provided
with the kits(if provided).

39.  Ensure that a laboratory’s SOPs and internal QC procedures
are working satisfactorily.
 EQA schemes help to identify errors, to improve the quality
of work, stimulate staff motivation and assure clients that
the laboratory is performing to the standard required and
to provide reliable results.
 WHO recommends EQA four times a year.
External Quality Control(EQA)

40. External Quality Control(EQA)
• An EQA organizer provides surveys in which identical
material will be tested by all participating laboratories
• Participating laboratories send specimens to EQA organizer
for Rechecking
• On-site visits with physical assessment)

41. Documentation
• If you have not documented it,
you have NOT done it …
• If you have not documented,
it is a RUMOUR !!!

42. S.No. Date Patient
name
Lab
Id
Age/S
ex
Test
requir
ed
Clinic
al
histor
y
Metho
d
applie
d
Result Perfor
med
by
Verifi
ed by
Documentation
Documentation of various tests

43.  Chemicals
 Plasticware
 Kits
Nonconsumables
 Equipments
 Glassware
Stock entry(Inventory)
Consumables
Documentation

44. Laboratory accident register
Documentation

45. Value of Documentation
• Ensures processes and outcomes are traceable
• Processes can be audited, thus external
assessments can take place
• Tool for training
• Reminds you what to do next

46.  All equipments having a effect on the accuracy
of result of the test should be calibrated before
put into service and on regular intervals
thereafter.
 Clear operating, cleaning instructions and
service sheets recording the functioning.
 Referigerators
 Incubators
 Waterbaths
Control of Equipments

48.  Continuing education program and in-service
training.
 All laboratory personnel should be encouraged to
participate in local, regional and national seminars
and workshops.
 Blind unknown samples for laboratory testing should
be included in test runs.
 Any error/source of error should be pin-pointed and
corrected.
QC of laboratory personnel

49. Accreditation
• Process of inspection of laboratories and
their licensing by a third party to ensure
conformity to pre-defined criteria
• Last step of the entire process
1. Quality assurance (procedures, way of
working)
2. IQC
3. EQC
4. … and then only accreditation if 1-
3completed

50. • Clinician
• Administrator
• Laboratory specialist

51. Laboratory services
Quality managementHealth care to all

52. Bottom-line
•Quality costs ,
•but poor quality costs more …
€

53. Thank You