Lab QA Manual

Dr. Ram Manohar Lohia Combined Hospital , Lucknow

Quality Operating Process

Document No : RML/LQA/01

Manual of OperationLaboratory Quality

Assurance

Date of Issue : 15/1/2008

Service Name : Laboratory Quality Assurance

Date Created : 15-01-2008

Approved By :

Chief Medical Superintendent

Name :

Signature :

Reviewed By :

Senior Consultant - Pathologist

Name :

Signature :

Issued By :

Director

Name :

Signature :

Responsibility of

Updating :

Senior Consultant - Pathologist

Name :

Signature :

Manual of Operation1

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Sl.Order Particulars

A Purpose

B Scope

C Introduction

D Quality Policy

E Management of Human Resource

F Procedures

G Policies

H Location

I Internal Environment

J Instruments, Reagents and Relevant consumables

K Validation of examination procedures

L Laboratory safety and preventive Bio hazard

M List of Examination Procedure

N Request protocols, Primary Sample etc

O Validation of Test result

P Quality Control

Q Reporting of Result

R Remedial action and Handling of complaints

S Communication and interaction with Patients

A. Purpose: To ensure continuous provision of quality in the operation of the Department of Laboratory







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Medicine and Blood Bank.

B. Scope: Hospital Wide

C. Introduction:

The Department of Laboratory Medicine and Blood Bank is situated in the first floor. It is composed of Phlebotomy, Clinical Pathology, Hematology, Serology, Biochemistry and Blood Bank facilities.

The laboratory is exclusively intended to serve the needs of the patients of the hospital and its services are not extended to any outside facility.

D. Quality policy:

The Department of Laboratory Medicine and Blood Bank assures accurate and reliable test result following

the established standard operating procedure to facilitate better diagnosis and treatment of patients .The

Department also assures to protect the integrity and safety of its patient and staff.

E. Management of Human Resource:

Staff Education and Training:

i. New Employee:

i. Every new employee (Fresh Recruited or Transferred) is given department induction training

to acquaint them with the mode of operation of the department, service delivery standard,

quality policy etc.

ii. The department head is responsible to oversee the training of staff and its suitability.

ii. Regular In service Training:

i. Regular In service training is provided to the staff to widen their ambit of knowledge,

improve performance standard and ensure their acceptability to the change in technology,

work method etc.

ii. Training sessions by company engineers are arranged for the departmental staff when ever

new equipment is introduced in the work culture of the department.

iii. Staff members are send for external training sessions.

iv. Interdepartmental training sessions are arranged by the Head of the Department.







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F. Procedure:

The Department will follow the below mentioned guideline instructions to ensure quality in its mode of

operation:

Head of Laboratory Services will conduct random checks of procedure or test. Feed back from clinicians will be obtained at regular interval. Internal and external quality checks for analytical error detection. Cross checking of abnormal slides. Repetition of abnormal values. Defining quality goals or standards. Periodic quality assessment by head of laboratory services

G. Policies:

a. Document control:

Records, maintenance and archiving: Document Amendment Form

Record File Name

Number Date Page no Amendment Authorized by

01

02

03

04

05

06

07

08

09

10

b. The documentation and its accessibility is as follows

Sl No Name of the record Form of Maintaining Access Who has the access







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the record Personnel /

Controlling

authority

mode

01 Patients Report

Records

Hard Copy Laboratory

Technician

Restricted Laboratory Staff

02 Procedure Manual Hard Copy Head of the

Department

Free Hospital Staff

03 Standard Operating

procedure

Hard Copy Head of the

Department

Free Hospital Staff

04 QC Data Hard Copy Senior

Laboratory

Technician


05 Quality audit report and

review Reports

Hard Head of the

Department


06 Employee Job

description

Hard Head of the

Department


08 Blood Bank Records Hard copy Head of the

Department and

Blood Bank

Technicians

Restricted Head of the Department

Blood Bank Technicians

and Blood Bank Nurse.

10 Patients Test

Requisition Form

Hard copy Laboratory

assistant

Free All Laboratory

Technicians and

Pathologist

11 Outsource report copies Hard copy Laboratory

assistant

Free All Laboratory

Technicians and

Pathologist

12 Patients tests value

observation record

Hard copy All Technicians Free All Laboratory

Technicians and







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Pathologist.

13 Calibration reports Hard copy All Laboratory

Technician and

Assistants

Free Laboratory Staff

14 Instrument manuals Hard copy All Laboratory

Technicians and

Assistants

Free Laboratory Staff.

H. Location of the Laboratory:

The Department of Laboratory and Blood Bank is located in the first floor of the hospital conveniently connected to the rest of the hospital by means of stairs and ramps.

I. Internal Environment of the Department:

Adequately lit and clean environment and ambient temperature conditions maintained by room AC and well appointed ventilation system.

Convenient waiting area for the patient. Convenient, easily recognizable sample collection area. Space and layout are optimum and appropriate for sample handling and throughput. Adequate toilet facilities available for patients, staff and accompanying persons. Reasonable provision is available for the entry of ill and disabled patients. Provision for privacy during sample collection. Laboratory department also has a licensed blood bank under its purview.

J. Instruments, reagents and relevant consumables:

Equipment:

The procedure for purchase of new equipments or replacement of existing equipment is as follows:

Identify the need for new / replacement of equipment and determine the broad technical specifications for the same. The list is forwarded to the office of the Chief Medical Superintendent

Administrative Office undertakes the procedure for collection of literature and quotations from different vendors.

Post collection of quotation from the vendors, administrative department forwards the same along with the technical specification to the Lab department from preparation of technical comparison..

Technical comparison of equipment is prepared. The list is sent to administrative authorities along with the recommendations of the Head of Lab

Services. Head of lab services is involved in the final decision. The final recommendation is forwarded to the specific office of the Health and Family Welfare

Department, Government of Uttar Pradesh for final approval and release of fund.







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Following priorities are taken into consideration while purchasing any equipment for the laboratory services :1. its suitability for its intended purpose.2. its operation is easy to understand for its intended users.3. its suitability for the present operating condition.4. its ability to meet safety and quality standards and requirements.5. its should satisfy above in a cost effective manner.6. Should comply with international regulations Like CE, FDA approval, etc.

For purchasing reagents, chemicals and relevant consumables :

Specifications claimed by the manufacturer are cross verified in the case of all reagents

Selection of vendor are done carefully after considering the following points :

1. should have proper storage facilities for reagents/chemicals/consumables2. should have a good reputation for ethical practice.3. should have financial stability.4. should always have sufficient stock of materials.5. must produce MSDS / Traceability or other relevant documents.

K. Validation of examination procedure:

Validation of the examination procedure technically and clinically will be done by qualified, well trained pathologists.

L. Laboratory Safety and Prevention of Bio Hazard:

The Department of Laboratory Medicine and Biohazard upholds the importance of safe work practices and better work environment for effective and efficient functioning of services provided by the department .The laboratory safety and Biohazard manual are to be referred for the detailed policy guidelines followed by the department. M. List of examination procedure:

The following list of test is enclosed herewith:

a. Test available in the hospitalb. Test not available in the hospital which are outsourced.

N. Request protocols, primary sample, collection and handling of laboratory samples:

All laboratory test requisition slip are duly signed ,timed and dated by the doctor.







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In case the patient does not have a requisition form, the consultant is called and the orders are written down by the technician.

SOPs documented for sample collection are strictly adhered while collecting patients sample. Handling of samples is strictly according to the guideline instruction indicated in the laboratory

safety policy.

O. Validation of test results:

Validation is done based on following Daily internal QC. Thrice a day QC in case of Hematology. Participation in external quality control programme. All procedures and processes of laboratory are approved and monitored by pathologists. Inputs on clinical utility of the test results are obtained from consultants and analyzed.

P. Quality control:

Laboratory adheres to the following steps to ensure analytical quality of the test results produced:

Head of Laboratory Services will are involved in the procurement of all chemicals and reagents required by the laboratory.

Calibration of equipments are done strictly as per the recommendations of the equipment manufacturer.

Products recognized and certified by appropriate national and international are only in laboratory. Wherever possible, third party control materials are used as internal and external controls. Two or three level control material are used to assess the performance of an analyte, eg; two level

controls materials are used in routine biochemistry, urine analysis and three level control materials in coagulation, blood gas, immunoassay and hematology analyzers.

Internal quality control is done once everyday in the case of biochemistry, immunoassay, blood gas, urine analyzer, coagulation; and thrice a day in the case of hematology.

Acceptance or rejection of run of internal quality control is based on Total Error Concept ( based on CLIA 88 total quality acceptance limits).

Acceptable performance target value for analytes is listed in annexure 1. .

Q. Reporting of the results:

1. Test results for samples collected between 8.00 am to 11.00 am (except for ‘stat’ investigations) will be

available by 2.00 pm on the same day.

2. Test results for samples collected after 11.00 am to 2.00pm (except for ‘stat’ investigation) will be

available next day by 10.00 am.

3. Investigation request received from critical care areas of the hospital like Emergency, ICU, ICCU, OT

etc would be given priority.







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4.. Incase of emergency cases and critical results ,the doctor is immediately informed over phone about the

outcome of the test results by the laboratory staff and the same is documented.

R. Remedial actions and handling of complaints:

For all complaints a root cause analysis will be done and appropriate corrective and prevention action will be implemented immediately.

S. Communications and other interactions with patients, health professionals, referral laboratories and supplies.

No reports is communicated to the patients or others directly on the phone or verbally except in emergency cases or critical results where the results are intimate verbally or over phone as referred in the laboratory procedure manual.

All communications to the referral laboratories pertaining to patient details is done by Pathologists, or by the laboratory technician.

Communication with laboratory suppliers is done by Head of Laboratory Services, in his absence by Sr. lab technician.

Annexure 1CLIA 88 Analytical Quality RequirementsRoutine chemistry:Test or Analyte Acceptance Performance Albumin Target value ± 10%Alkaline phosphatase Target value ± 30%Amylase Target value ± 30%Asparate aminotransferase ( AST) Target value ± 20%Bilirubin, total Target value ± .04%

Or ± 20% ( greater)Blood gas pO2 Target value ± 3 SDBlood gas pCO2 Target value ± 5 mmHgBlood gas pH Target value ± 0.04Calcium, total Target value ± 1.0 mg/dLChloride Target value ± 5%Cholesterol, total Target value ± 10%Cholesterol, High Density lipoprotein Target value ± 30%Creatinine Target value ± 0.3 mg/dl

Or ± 15% ( greater)Glucose Target value ± 6 mg/dL

Or ± 15% ( greater )Iron, total Target value ± 20%Lactate dehydrogenase(LDH) Target value ± 20%Magnesium Target value ± 25%







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Potassium Target value ± 0.5 mmol/LSodium Target value ± 4 mmol/LTotal protien Target value ± 10%Triglycerides Target value ± 25%Urea Nitrogen Target value ± 2 mg/dL

Or ± 9% ( greater)Uric acid Target value ± 17%

HematologyCell identification 90% or greater consensus on identificationWhite cell differential Target± 3 SD based on percentage of different types

of white cellsErythrocyte count Target± 6%Hematocrit Target± 6%Hemoglobin Target± 10 %Leucocyte count Target± 15%Platelet count Target± 25%

General immunologyAntistreptolysin O Target value ± 2 dilution

Or ( Positive or negative) Anti – Human Immunodeficiency virus (only blood count)

Reactive or non reactive

Hepatitis ( HBs Ag, anti – HBc, HBeAg) Reactive ( positive )Or non reactive( negative)

Rheumatoid factor Target value ± 2 dilutionOr ( Positive or negative)



Lab QA Manual

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