QUALITY MANUAL

OF

Taluk Head Quarters Hospital

Chavakkad

Chavakkad p.o

Pin- 680501

ISSUE NO: 01

ISSUE DATE: 01.07.2009

COPY NO:01

HOLDER’S NAME: SUPERINTENDENT

THQH CHAVAKKAD

TALUK HEAD QURETRS HOSPITAL CHAVAKKADQUALITY MANUAL Q.C.I. ESSENTIAL STANDARDS

SECTION A Release authorization page PAGE 01/01

A. RELEASE AUTHORISATION

The Quality Manual is released under the authority

of Dr. MINIMOL A.A, SUPERINTENDENT , THQ

HOSPITAL, CHAVAKKAD and is the property of the

LABORATORY, THQ HOSPITAL, CHAVAKKAD,

CHAVAKKAD P.O, Pin 680501.

Sign & Designation

Document No :01 Issue No. 1 Amendment No.Page No : 1 Issue Date: 1.7.2009 Amendment Date.Prepared by . Noorjahan.A. Lab technician , THQH Chavakkad

Approved by : Dr. Mini mol A.ASuperintendent THQH Chavakkad

Issued by:

TALUK HEAD QURETRS HOSPITAL CHAVAKKAD

QUALITY MANUAL Q.C.I. ESSENTIAL STANDARDS SECTION B Quality Policies and Objectives PAGE 01/01

B QUALITY POLICY AND OBJECTIVES

Taluk Head Quarters hospital Laboratory is committed to producing reliable patient test results in a manner necessary to insure appropriate and timely patient care. The laboratory will strive to produce reliable patient test results by combining processes that promote efficiency with technology that is appropriate to the laboratory mission and operated by staff that is both trained and competent to perform the work complying with the QCI essential standard and all other regulatory bodies.

Document No Issue No. 1 Amendment No.Page No : 2 Issue Date: 1.7.2009 Amendment Date.Prepared by . Noorjahan.A. Lab technician , THQH Chavakkad

Approved by : Dr. Mini molA.ASuperintendent THQH Chavakkad

Issued by:

AMENDMENT PAGE

SlNo:

Page No:Date of

AmendmentAmendment

Madedescription

Reason forAmendment

Sign of personAuthorised

amendment

TALUK HEAD QURETRS HOSPITAL CHAVAKKADQUALITY MANUAL Q.C.I. ESSENTIAL STANDARDS

SECTION C Amendment page PAGE 01/01

Document No Issue No. 1 Amendment No.Page No : 3 Issue Date: 1.7.2009 Amendment Date.Prepared by . Noorjahan.A. Lab technician , THQH Chavakkad

Approved by : Dr. Mini molA.ASuperintendent THQH Chavakkad

Issued by:

DISTRIBUTION LIST

The following are the authorized holders of the controlled copy of the quality manual .

CONTROLLED COPY NO:

NAME & DESIGNATION O THE HOLDEROF THE CONTROLLED COPY

TALUK HEAD QURETRS HOSPITAL CHAVAKKADQUALITY MANUAL Q.C.I. ESSENTIAL STANDARDS

SECTION D Distribution list PAGE 01/01

1 Superintendent , THQH Chavakkad

2 Laboratory technician, THQH Chavakkad

Document No Issue No. 1 Amendment No.Page No : 4 Issue Date: 1.7.2009 Amendment Date.Prepared by . Noorjahan.A. Lab technician , THQH Chavakkad

Approved by : Dr. Mini molA.ASuperintendent THQH Chavakkad

Issued by:

Contents Sections Page No.Quality manual 1Release Authorization A 2Quality policy and objective B 3Amendment Sheet C 4Distribution list D 5Table of contents 6Introduction 1 7Scope of the testing services 2 8Essential standards for Medical laboratories 3 9Organogram 3.1 10Organization 3.1.1. 11Quality management 3.1.2 12Management review 3.1.3 13Personal 3.2 14 Equipments and instruments 3.3 16Procurements 3.4.1 17

TALUK HEAD QURETRS HOSPITAL CHAVAKKADQUALITY MANUAL Q.C.I. ESSENTIAL STANDARDS

SECTION 3.1.1 Contents PAGE 01/01

External services 3.4.2 18Process control 3.5.1 19Quality assurance 3.5.2 20Pre analytical – Sample collection manual 3.5.3 21Analytical process 3.5.4 23Post analytical process 3.5.5 24Reporting 3.5.6 25Document control 3.6 26Internal audit 3.7 27Control of non conformities 3.8 28Continual quality improvement 3.9 30

Document No Issue No. 1 Amendment No.Page No : 5 Issue Date: 1.7.2009 Amendment Date.Prepared by . Noorjahan.A. Lab technician , THQH Chavakkad

Approved by : Dr. Mini molA.ASuperintendent THQH Chavakkad

Issued by:

INTRODUCTIONDocument No Issue No. 1 Amendment No.Page No : 6 Issue Date: 1.7.2009 Amendment Date.Prepared by . Noorjahan.A. Lab technician , THQH Chavakkad

Approved by : Dr. Mini molA.ASuperintendent THQH Chavakkad

Issued by:

Our laboratory, THQH Chavakkad is situated in Chavakkad Municipality around km away from Chavakkad centre. This institution was Established on 1932.Now it has a staff strength of 94 that is one Medical Superintendent , one Deputy superintendent ,six assistant surgeons and three doctors from NRHM,and the remaining include, nursing staffs, Para medical staff, field staff, nursing assistants and cleaning staff. This Laboratory

TALUK HEAD QURETRS HOSPITAL CHAVAKKADQUALITY MANUAL Q.C.I. ESSENTIAL STANDARDS

SECTION 1 Introduction PAGE 01/01

gives service to 41742 populations under Chavakkad municipality . This is a laboratory examining an average of 70 samples daily. This laboratory functions as the central function for the clinical decisions in Chavakkad. Our lab is under the control of Chavakkad municipality & Kerala government.

We provide the following testing results carried out on patient samples using the available resources and facilities.

1. Clinical Biochemistry – Blood sugar,

2. Clinical pathology – Urine albumin, sugar, microscopical examination, bile salt, bile pigment, urine acetone and pregnancy test.

3 Hematology - Total WBC count, Differential count, Eerythrocyte sedimentation rate, Heamoglobin estimation, Platelet count, Clotting time, Bleeding time and Peripheral smear for MP smear .

3. Serology - Serum Widal. Details of standards operating procedure attached.

Document No Issue No. 1 Amendment No.

Page No : 7 Issue Date: 1.7.2009 Amendment Date.Prepared by . Noorjahan.A. Lab Approved by : Dr. Mini molA.A Issued by:

TALUK HEAD QURETRS HOSPITAL CHAVAKKADQUALITY MANUAL Q.C.I. ESSENTIAL STANDARDS

SECTION 2 SCOPE OF TESTING PAGE 01/01

technician , THQH Chavakkad Superintendent THQH Chavakkad

Document No Issue No. 1 Amendment No.Page No : 8 Issue Date: 1.7.2009 Amendment Date.Prepared by . Noorjahan.A. Lab technician , THQH Chavakkad

Approved by : Dr. Mini mol A.ASuperintendent THQH Chavakkad

Issued by:

The THQH,Chavakkad Laboratory was established…in ….. and Located at

permanent site Chavakkad near the kozhikullangara temple is under the ownership of Govt. of Kerala, Health Service department registered with local authority-chavakkad municipality

Declaration of ownership

Ownership - Govt. of Kerala

GOVT. OF KERALA   

   

DIRECTORATE OF HEALTH

 

DISTRICT MEDICAL OFFICER

MANAGING DIRECTOR &

MEDICAL DIRECTOR

MEDICAL SUPERINTENDENT, THQH CHAVAKKAD

     

LABORATARY DIRECTOR

LAB TECHNICIAN THQH,CHAVAKKAD

     

HOUSE KEEPING

HOSPITAL ATTENDANT GR II

     

TALUK HEAD QURETRS HOSPITAL CHAVAKKADQUALITY MANUAL Q.C.I. ESSENTIAL STANDARDS

SECTION 3.1 ORGANOGRAM PAGE 01/01

TALUK HEAD QURETRS HOSPITAL CHAVAKKADQUALITY MANUAL Q.C.I. ESSENTIAL STANDARDS

SECTION 3.1.1 ORGANIZATION PAGE 01/01

Finance – Lay secretary ,THQH,Chavakkad

Administration - Superintendent, THQH, Chavakkad

This Laboratory has no branches and collection centers.

The laboratory management & lab technicians are committed to comply with the requirement of essential standards & the regulatory requirements at the times.

Dr.C.K.Satheesan, Medical Officer in Charge is the designated quality manager who countercheck all the laboratory results. Technical manager is Laboratory technician Smt.Noorjahan Nasar.

All the persons working in the laboratory promote close working relationship to the other staff. The technical manager designated with well defined responsibilities. Continual training is designated to all the persons in the laboratory.

Document No Issue No. 1 Amendment No.Page No :9 Issue Date: 1.7.2009 Amendment Date.Prepared by . Noorjahan.A. Lab technician , THQH Chavakkad

Approved by : Dr. Mini mol A.ASuperintendent THQH Chavakkad

Issued by:

Our quality policy, procedures and manual are documented and they are communicated to all lab persons. We ensure that documents are read, understood and implemented by all lab persons at all time.

Quality management includes the standard of services, quality

management, procedures, technical operation procedures and control of

documents.

TALUK HEAD QURETRS HOSPITAL CHAVAKKADQUALITY MANUAL Q.C.I. ESSENTIAL STANDARDS

SECTION 3.1.2 QUALITY MANAGEMENT PAGE 01/01

We are carrying out internal quality control, equipment maintenance, as

part of the quality management of its technical operations.

Document No Issue No. 1 Amendment No.Page No : 10 Issue Date: 1.7.2009 Amendment Date.Prepared by . Noorjahan.A. Lab technician , THQH Chavakkad

Approved by : Dr. Mini mol A.A

Superintendent THQH Chavakkad

Issued by:

TALUK HEAD QURETRS HOSPITAL CHAVAKKADQUALITY MANUAL Q.C.I. ESSENTIAL STANDARDS

SECTION 3.1.3 MANAGEMENT REVIEW PAGE 01/01

Our Management committee members consist of Lab Director,Medical officer In charge ,Head nurse,Lab technician and PRO/Block co-ordinator.

Document No Issue No. 1 Amendment No.Page No : 11 Issue Date: 1.7.2009 Amendment Date.Prepared by . Noorjahan.A. Lab technician , THQH Chavakkad

Approved by : Dr. Mini mol A.A

Superintendent THQH Chavakkad

Issued by:

Chief Executive of the laboratory – Dr. Minimol A.A ,Superintendent (0487-2507310)

Person responsible for the quality management system - do - Person responsible for the

Our

quality manager

review the internal audit report,

internal quality control report,

Laboratory service feed back &

complaint records at one

time in a year.

The reviewed reports

are documented.

TALUK HEAD QURETRS HOSPITAL CHAVAKKADQUALITY MANUAL Q.C.I. ESSENTIAL STANDARDS

SECTION 3.2 PERSONNEL PAGE 01/02

technical operations – Mrs Noorjahan Nasar ,Lab Technician, (0487-2507310)

Control person for QCI -- Dr. Minimol A.A ,Superintendent (0487-2507310) The Medical Officer is the signaturing authority of all lab results and the supervisory Officer of the laboratory. The laboratory technician is the responsible person for registering and record keeping, conducting all technical work related to the laboratory and maintaining the cleanness of the laboratory. The Hospital Attender GrII is the responsible person for cleaning the laboratory.

APPOINTMENT OF STAFF One lab technician is appointed through employment exchange of Kerala Government,two lab technicians and one lab attender are appointed by Kerala Public Service Commission through the District Medical Officer of Health by the direction of Health Department.

TRAININGDocument No Issue No. 1 Amendment No.Page No : 12 Issue Date: 1.7.2009 Amendment Date.Prepared by . Noorjahan.A. Lab technician , THQH Chavakkad

Approved by : Dr. Mini mol A.A

Superintendent THQH Chavakkad

Issued by:

Periodical training conducted by the District Medical Officer of Health, Thrissur through the superintendent, Thqh ,Chavakkad and help of National Rural Health Mission, Aids Control Society, and National Vector Born Diseas Control Programme. Monthly evaluation is done by Superintendent and directions by Superintendent

DETAILS OF STAFF

Sl. No.

Name DesignationAcademic & professional qualification

Experience related to

TALUK HEAD QURETRS HOSPITAL CHAVAKKADQUALITY MANUAL Q.C.I. ESSENTIAL STANDARDS

SECTION 3.2 PERSONNEL PAGE 02/02

present work

1 Dr. Mini mol A.A Superintendent MBBS, 10 yrs.2 Mrs Noorjahan

NasrLab.

TechnicianBSc ,DMLT 10yrs.

3 Mr Kishore STLS DMLT 10 yrs.4 Mrs Meenu Lab technician DMLT 2yrs5 Mrs T.T.Mary Lab attender SSLC 2yrs

Document No Issue No. 1 Amendment No.Page No : 13 Issue Date: 1.7.2009 Amendment Date.Prepared by . Noorjahan.A. Lab technician , THQH Chavakkad

Approved by : Dr. Mini mol A.ASuperintendent THQH Chavakkad

Issued by:

QSP for Equipments and instruments

Sl. No

.

Name of equipment

Model/type/

Unique id no

Receipt date&place in service

Authorised personnel to

use lab equipment

Range & Accuracy Date of last

calibrationCalibration due on

1Binocular Microscope

Technical manager

2 Centrifuge Technical manager

3 Water bath

Technical manager

Document No Issue No. 1 Amendment No.Page No : 15 Issue Date: 1.7.2009 Amendment Date.Prepared by . Noorjahan.A. Lab technician , THQH Chavakkad

Approved by : Dr.Mini mol A.A Superintendent THQH Chavakkad

Issued by:

Most of the reagents and kits are purchased externally. RNTCP reagents are prepared

in our lab by STLS. The financial aid is given by the municipality and Hospital

management committee. We insist good quality of reagent that is their brand names

are quoted for purchasing. Prior to this a non availability certificate is obtained from

the District medical store. We purchase reagents with long expiry date. All these items

purchased from H.D.C fund is by inviting quotation procedures. We document the

Selection of suppliers and reagents. We evaluate supplies of critical reagents, supplies

and services that affect the quality of examination and maintain records of such

evaluations. We maintain a list of such approved suppliers. The laboratory has a

documented procedure for selection and use of purchased external services are

TALUK HEAD QURETRS HOSPITAL CHAVAKKADQUALITY MANUAL Q.C.I. ESSENTIAL STANDARDS

SECTION 3.3 List of Equipments and instruments

PAGE 01/01

TALUK HEAD QURETRS HOSPITAL CHAVAKKADQUALITY MANUAL Q.C.I. ESSENTIAL STANDARDS

SECTION 3.4.1 PROCUREMENTS PAGE 01/01

appropriate. The Government procedures are being followed. The laboratory has an

inventory control system. Records of external services, supplies and purchased

products are maintained.

The laboratory has a procedure for evaluation of suppliers of reagents, supplies

and services that affect the quality of examinations. Records of such evaluation are

maintained. The laboratory maintains a list such approved suppliers.

Document No Issue No. 1 Amendment No.Page No : 15 Issue Date: 1.7.2009 Amendment Date.Prepared by . Noorjahan.A. Lab technician , THQH Chavakkad

Approved by : Dr.Mini mol A.A Superintendent THQH Chavakkad

Issued by:

The laboratory has a well defined and documented procedure for selection of referral laboratories. Laboratory also

documents the test that is referred out for analysis. The laboratory ensures that the

results received from external laboratories are appropriate.

TALUK HEAD QURETRS HOSPITAL CHAVAKKADQUALITY MANUAL Q.C.I. ESSENTIAL STANDARDS

SECTION 3.4.2 EXTERNAL SERVICES PAGE 01/01

Document No Issue No. 1 Amendment No.Page No : 16 Issue Date: 1.7.2009 Amendment Date.Prepared by . Noorjahan.A. Lab technician , THQH Chavakkad

Approved by : Dr.Mini mol A.A Superintendent THQH Chavakkad

Issued by:

LABORATORY SPACE

Our laboratory has sufficient space and appropriate conditions to

ensure policy services.

There is effective separation of area for its various activities and

only authorized persons are allowed to enter into the laboratory room.

The laboratory is monitoring, controlling and documenting all

environmental conditions which may affect the quality of its service.

Appropriate waste management & environment protection

procedures are maintained in our laboratory.

TALUK HEAD QURETRS HOSPITAL CHAVAKKADQUALITY MANUAL Q.C.I. ESSENTIAL STANDARDS

SECTION 3.5.1 PROCESS CONTROL PAGE 01/01

Document No Issue No. 1 Amendment No.Page No : 17 Issue Date: 1.7.2009 Amendment Date.Prepared by . Noorjahan.A. Lab technician , THQH Chavakkad

Approved by : Dr.Mini mol A.A Superintendent THQH Chavakkad

Issued by:

We have a quality assurance programme designed to assure the reliability

and usefulness of the laboratory to the patients. We are performing internal quality

control using known concentration of specimen supplied with kits. All these are

documented and records are maintained.

Document No Issue No. 1 Amendment No.Page No : 18 Issue Date: 1.7.2009 Amendment Date.Prepared by . Noorjahan.A. Lab technician , THQH Chavakkad

Approved by : Dr.Mini mol A.A Superintendent THQH Chavakkad

Issued by:

TALUK HEAD QURETRS HOSPITAL CHAVAKKADQUALITY MANUAL Q.C.I. ESSENTIAL STANDARDS

SECTION 3.5.2 QUALITY ASSURANCE PAGE 01/01

We have a sample collection manual having specific instructions for patient preparation, identification, procedure for sample collection, including specification on sample container, and storage of samples before analysis.Our laboratory provides all relevant details of patient samples. Trace ability of the sample exist to an identified patient with appropriate request form. We have an established procedure for handling samples without request form.

Our laboratory maintains a criteria for acceptance or rejection of sample.

Procedure1.Except for AFB sputum sample for all other test a requisition for the test is to be obtained duly signed by the medical officer/nurse.2.This requisition is sent to the lab along with samples or patient and the lab assistant/technician collect the sample.3. Patient identification to be done on the basis of a receipt or a requisition.Cross check verbally with patient.4.Inpatient sample collected from ward.5.Out patient sample collect from sample collection area.6.Labelling with lab number, name, age ,name of test with time of collection.

Criteria for sample rejection.

The following samples will not to be accepted.1.Unlabelled or improperly labeled samples.2. Haemolysed samples3.Lipaemic samples.4.Discrepancies between requisition form and samples.5.Clot in anticoagulant.6.Wrong tube used for collection.7.Sample contamination.

Document No Issue No. 1 Amendment No.Page No :19 Issue Date: 1.7.2009 Amendment Date.Prepared by . Noorjahan.A. Lab technician , THQH Chavakkad

Approved by : Dr.Mini mol A.A Superintendent THQH Chavakkad

Issued by:

TALUK HEAD QURETRS HOSPITAL CHAVAKKADQUALITY MANUAL Q.C.I. ESSENTIAL STANDARDS

SECTION 3.5.3 PRE-ANALYTICAL PAGE 01/01

Our laboratory use only the standard methods published in enclosed journals and standard text books. The head of the laboratory annually review the methods and reference values. All test methods one documented.

We maintain a standard operating procedure, which is clearly written in simple language as per the guideline given in the standard text books of specific discipline and under stood by all technical staff performing the test.

Document No Issue No. 1 Amendment No.Page No : 20 Issue Date: 1.7.2009 Amendment Date.Prepared by . Noorjahan.A. Lab technician , THQH Chavakkad

Approved by : Dr.Mini mol A.A Superintendent THQH Chavakkad

Issued by:

TALUK HEAD QURETRS HOSPITAL CHAVAKKADQUALITY MANUAL Q.C.I. ESSENTIAL STANDARDS

SECTION 3.5.4 ANALYTICAL PROCESS PAGE 01/02

STANDARD OPERATING PROCEDURES

Sl. No.

Material examined

Specific tests examination performed

Specification, std/technique

used

Range of tests/Limit of

detection% of cv/mu

1Whole blood

HbSahli’s

Haemoglobin method

<12 -15gm%Internal

Quality Control

2Whole blood

Total WBC count

Turk’s Method4000-11000 cells/cmm

"

3Whole blood

Differential Count

Leishman’s Method

- "

4Citrated

BloodESR

Westegren’s Method

0 -20mm/hr "

5Serum/ Plasma

Blood sugarGOD-PAP

Method

Above 500 mg% dilute the sample

with normal saline“

6Whole Blood

Malarial Parasite

Leishman’s Method

-Cross checking in CML &RLC

7 Urine Albumin

Sulphosalicilic acid

Method/Strip Method

Nil- +++“

8 Urine SugarBenedict’s/Strip

methodNil – 2% “

9 Urine AcetoneRothera’s Method

Negative / Positive “

10 Urine Bile Salt Hay’s Method Absent/Present “

11 Urine Bile PigmentFouchet’s Method

Absent/Present “

12Urine

Microscopic Examination

Centrifuging - “

13 Urine Pregnancy “

14 Sputum AFBZeil-Neelson

MethodNegative – 3+ “

Serum Widal

Rapid slide test span diagnostic

semi quantitative

slide test

-Internal

Quality control

Document No Issue No. 1 Amendment No.Page No : 21 Issue Date: 1.7.2009 Amendment Date.Prepared by . Noorjahan.A. Lab technician , THQH Chavakkad

Approved by : Dr.Mini mol A.A Superintendent THQH Chavakkad

Issued by:

TALUK HEAD QURETRS HOSPITAL CHAVAKKADQUALITY MANUAL Q.C.I. ESSENTIAL STANDARDS

SECTION 3.5.4 ANALYTICAL PROCESS PAGE 02/02

TALUK HEAD QURETRS HOSPITAL CHAVAKKADQUALITY MANUAL Q.C.I. ESSENTIAL STANDARDS

SECTION 3.5.5 POST ANALYTICAL PROCESS PAGE 01/01

We are designating the Medical officer to approve the test results.

The unused portion of the sample is kept until the result is issued to the patient.

The laboratory technicians discard the unused samples as per the documented procedure

DISPOSAL OF SPECIMENS

We have a documented procedure for discarding the unused samples. The laboratory technician are responsible for discarding the unused samples as per the rules of biomedical waste management system.

ProcedureThe samples are to be dealt with in the following manner after the test is conducted.

All routine blood samples – Discard after 24 hrs. All urine\stool samples – Discard on the same evening. Special tests samples – Discard after the dispatch of results.

Document No Issue No. 1 Amendment No.Page No : 22 Issue Date: 1.7.2009 Amendment Date.Prepared by . Noorjahan.A. Lab technician , THQH Chavakkad

Approved by : Dr.Mini mol A.A Superintendent THQH Chavakkad

Issued by:

TALUK HEAD QURETRS HOSPITAL CHAVAKKADQUALITY MANUAL Q.C.I. ESSENTIAL STANDARDS

SECTION 3.5.6 Reporting PAGE 01/01

Reporting is only through report format include the name of the laboratory, name

and identification of the patient, test requested, sample receiving date and time reporting

date, test result, names of the persons who reported and approved the results. The

laboratory maintains a copy of the test reports and request for an appropriate time.

Document No Issue No. 1 Amendment No.Page No : 23 Issue Date: 1.7.2009 Amendment Date.Prepared by . Noorjahan.A. Lab technician , THQH Chavakkad

Approved by : Dr.Mini mol A.A Superintendent THQH Chavakkad

Issued by:

We maintain all the results in the laboratory register which is maintained as a document.

We have a list of documents which are maintained inside the laboratory as per the order

mentioned below.

1. Register of registers

TALUK HEAD QURETRS HOSPITAL CHAVAKKADQUALITY MANUAL Q.C.I. ESSENTIAL STANDARDS

SECTION 3.6 Document Control PAGE 01/01

2. Stock register3. Indent book.4. Laboratory Register.5. Malaria Passive Register.6. Backlog Register & Technicians Diary.7. Inward Register/Time lag Register.8. Monthly Report File.9. Cross checking Report File.10.HDC Receipt book.11.Cleaning register12.Temperature chart register.

All these registers are kept under the safe custody of the laboratory technician

approved by the Medical Officer for a period of 5 years .

Document No Issue No. 1 Amendment No.Page No : 24 Issue Date: 1.7.2009 Amendment Date.Prepared by . Noorjahan.A. Lab technician , THQH Chavakkad

Approved by :Dr.Mini mol A.A Superintendent THQH Chavakkad

Issued by:

We have established and documented the plan for internal audit once in every year. These plans are maintained and recorded in the office. The Medical Officer examines the stock book for entering of instruments and reagents correctly, laboratory registers for recording of results, the expiry dates of different reagents and the procedures of different tests

TALUK HEAD QURETRS HOSPITAL CHAVAKKADQUALITY MANUAL Q.C.I. ESSENTIAL STANDARDS

SECTION 3.7 Internal Audit PAGE 01/01

Intended use – To ensure the patients complaints are resolved to maintain quality management.

Scope – Steps taken to resolve the clients’ complaints.

Responsibility – Medical Officer of THQH Chavakkad

Policy – THQH Chavakkad and its staff receive all the complaints and resolve them to ensure that better patient care is provided keeping the quality system of Lab as its main perspective. The complaints are resolved by carrying out a thorough analysis of the root cause of the problem. This is done to ensure the patients confidence in the lab is restored and also to safe guard the reputation of lab.

Procedure:

Document No Issue No. 1 Amendment No.Page No : 25 Issue Date: 1.7.2009 Amendment Date.

Prepared by . Noorjahan.A. Lab technician , THQH Chavakkad

Approved by Dr.Mini mol A.A Superintendent THQH Chavakkad

Issued by:

TALUK HEAD QURETRS HOSPITAL CHAVAKKADQUALITY MANUAL Q.C.I. ESSENTIAL STANDARDS

SECTION 3.8 CONTROL OF NON CONFORMITIES

PAGE 01/01

1. We receive all complaints and brought to the notice of the Medical Officer.2. We also receive the written complaints through the complaint box.3. The written & oral complaints are recorded in the complaint register of the

registration counter.4. The Medical Officer does a thorough enquiry into the problem with the help

of the laboratory technician.5. In case of any deficiencies, corrective action is taken.6. The corrective action is taken keeping the best interests of the patient in the

purview and with the objective to release the reports, which are close to the true value and without jeopardizing the quality in reporting of test results.

7.The problem based areas are dealt with strictly to ensure that there would be no non-conformity in the procedure carried out.

8;We unsure that there should be no repetition in the mistakes. An audit is conducted in the lab focused to that problem.

Document No Issue No. 1 Amendment No.Page No : 26 Issue Date: 1.7.2009 Amendment Date.Prepared by . Noorjahan.A. Lab technician , THQH Chavakkad

Approved by : Dr.Mini mol A.A Superintendent THQH Chavakkad

Issued by:

TALUK HEAD QURETRS HOSPITAL CHAVAKKADQUALITY MANUAL Q.C.I. ESSENTIAL STANDARDS

SECTION 3.8 CONTROL OF NON CONFORMITIES

PAGE 01/01

We are keeping a documental procedure for corrective action and preventive action. We have a mechanism for reviewing customer feed back, error or non conformity analysis which is reported to lab technician and Medical Officer. We are reviewing the quality system periodically to keep pace with the current trends.

PROCEDURE FOR CUSTOMER FEED BACK

Intended use: To procure customer feed back and to improvise the services towards better patient care.

Scope: Feed back on all lab investigations or services.

Responsibility: MO THQH Chavakkad

Policy: Our laboratory is open to the customer in the form of feed back. This is used to improvise the services to patients.

Procedure:

1. The customer feed back form is available from the laboratory.2. The above information is provided from the lab by display board.3. The completed forms are dropped in the suggestion box which placed in front of

the THQH.

Document No Issue No. 1 Amendment No.Page No : 27 Issue Date: 1.7.2009 Amendment Date.Prepared by . Noorjahan.A. Lab technician , THQH Chavakkad

Approved by : Dr.Mini mol A.A Superintendent THQH Chavakkad

Issued by:

TALUK HEAD QURETRS HOSPITAL CHAVAKKADQUALITY MANUAL Q.C.I. ESSENTIAL STANDARDS

SECTION 3.9 Continual Quality improvement PAGE 01/01

The completed forms are sorted and sent for evaluation to the laboratory

Document No Issue No. 1 Amendment No.Page No : 28 Issue Date: 1.7.2009 Amendment Date.Prepared by . Noorjahan.A. Lab technician , THQH Chavakkad

Approved by : Dr.Mini mol A.A Superintendent THQH Chavakkad

Issued by: