Dr. Ram Manohar Lohia Combined Hospital , Lucknow / Quality Operating Process / Document No :
RML/LQA/01
Manual of Operation
Laboratory 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 :
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
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.
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 FormRecord 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 ofthe record / Maintaining
Personnel /
Controlling
authority / Access mode / Who has the access
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 / Restricted / Laboratory Staff
05 / Quality audit report and review Reports / Hard / Head of the Department / Restricted / Laboratory Staff
06 / Employee Job description / Hard / Head of the Department / Restricted / Laboratory Staff
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 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.
· 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/consumables
2. 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 hospital
b. 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.
· 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.
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 1
CLIA 88 Analytical Quality Requirements
Routine chemistry:
Test or Analyte / Acceptance PerformanceAlbumin / 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 SD
Blood gas pCO2 / Target value ± 5 mmHg
Blood gas pH / Target value ± 0.04
Calcium, total / Target value ± 1.0 mg/dL
Chloride / 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%
Potassium / Target value ± 0.5 mmol/L
Sodium / Target value ± 4 mmol/L
Total protien / Target value ± 10%
Triglycerides / Target value ± 25%
Urea Nitrogen / Target value ± 2 mg/dL
Or ± 9% ( greater)
Uric acid / Target value ± 17%
Hematology
Cell identification / 90% or greater consensus on identification
White cell differential / Target± 3 SD based on percentage of different types of white cells
Erythrocyte count Target± 6%
Hematocrit / Target± 6%
Hemoglobin / Target± 10 %
Leucocyte count / Target± 15%
Platelet count / Target± 25%
General immunology
Antistreptolysin 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 dilution
Or ( Positive or negative)
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Manual of Operation