1. Dr Neeraj as has kindly provided the list the records (with their
formats) necessary to meet the requirements of the ISO
Standard…………………
These r part of the courses ………………
This format has been applied ……………………….
The formats ……………………… approved
The labs may use these formats or …………………………………
The lab may keep add to the list
Delete not applicable ………………………………………………..
2.
3.
4. S.No. Document Name CLAUSE
1 Communication with staff 4.1
2 Document Distribution Record
4.3
3 Revision History of Documents
4 Service Agreement Deviation Form 4.4
5 Agreement-Part Time Consultants
4.5
6 Ref Lab Evaluation Format
7 Sample outsourced format
8 Advisory Services Format 4.7
9 Internal Complaint Format
4.8
10 Feedback Form – Patient
11 Daily Non conformance Report 4.9
5. S.No. Document Name CLAUSE
12 Corrective action form 4.10
13 Preventive Action Form 4.11
14 Continual Improvement Form 4.12
15 Quality Indicators
4.14
16 Turn Around Time
17 Audit Schedule
18 Audit Nonconformance Report
19 Internal Audit Report
20 Risk Assessment Form
21 Management Review Minutes 4.15
6. S.No. Document Name CLAUSE
22 Confidentiality Agreement
5.1
23 Employee health record
24 Induction Training Format
25 Annual Training Plan
26 Training need identification
27 Meeting / Training Attendance Sheet
28 Training Questionnaire
29 Incident / Accident Record
30 Employee training record
31 Employee Suggestion Form
32 Employee competency assessment form
7. S.No. Document Name CLAUSE
31 Employee Performance Appraisal Form
5.1
32 Employee personnel record
33 Employee Joining Letter
34 Temperature / Humidity Record Format
5.2
35 Housekeeping schedule
36 Toilet Cleaning Schedule
37 Waste Disposal Record
38 Equipment service log
5.3
39 Maintenance Schedule–Equipment
40 Decontamination Schedule – Equipment
8. S.No. Document Name CLAUSE
41 Verification Format – Equipment
5.3
42 Lot Verification format – New Kit
43 Test Requisition Form 5.4
44 Sample Rejection record 5.4
45 Validation & Verification Record 5.5
46 External QC corrective action record
5.6
47 Internal QC corrective action record
48 Sample Discard Record Format 5.7
49 Report Error Log 5.9
50 Critical / Alert Value Information Record Format 5.9
51 Software Validation & Verification
5.10
52 Charges Record
53 Maintenance Record
9. FORMS AND FORMATS
Prepared by Issued By Approved By
Quality Manager Quality Manager Lab Director
Name & Address of the Laboratory
10. INTERNAL AUDIT PLAN
Type of Audit Horizontal Vertical
P– Planned C – Conducted NC – NCR Closed NP – Next Planned
DEPARTMENT
JAN
201
FEB
201
MAR
201
APR
201
MAY
201
JUN
201
JULY
201
AUG
201
SEP
201
OCT
201
NOV
201
DEC
201
Lab Management
Reception
Sample Collection
Stores & Purchase
Reporting / I.T
Maintenance
Housekeeping
Clinical Biochemistry
Hematology
Clinical Pathology
Serology
12. P– Planned C – Conducted NC – NCR Closed NP – Next Planned
Area//Activity
JAN
201
FEB
201
MAR
201
APR
201
MAY
201
JUN
201
JULY
201
AUG
201
SEP
201
OCT
201
NOV
201
DEC
201
Lab Management
Reception
Sample Collection
Stores & Purchase
Reporting / I.T
Maintenance
Housekeeping
Clinical Biochemistry
Hematology
Clinical Pathology
Serology
14. DEPARTMENT DATE TIME AUDITOR AUDITEE Sign
Lab Management
Reception
Sample Collection
Stores & Purchase
Reporting / I.T
Maintenance
Housekeeping
Clinical Biochemistry
Hematology
Clinical Pathology
Serology
AUDIT SCHEDULE
FROM Q Mgr DATE
TO All Concerned
15. AUDIT NON CONFORMANCE REPORT FORMAT
DATE
DEPTT
AUDITOR
AUDITEE
DETAILS OF N C R
CLAUSE / DOCUMENT VIOLATION:
NONCONFORMANCE: MINOR MAJOR OBSERVATION
Sign of Auditor Sign of Auditee
ROOT CAUSE
CORRECTIVE / PREVENTIVE ACTION PROPOSED
TARGET DATE
RESPONSIBILITY
CLOSURE VERIFICATION
√
CLOSURE - ACCEPTED NOT ACCEPTED
SIGN & REMARKS OF QMR / LEAD AUDITOR
Corrective action status check
STATUS Compliant Repeated
After 1 month
After 3 months
After 6 months
After 9 months
16. INTERNAL AUDIT REPORT
1 Internal Audit No (As per 15189:2012 Standards)
2 Date of Audit
3 Name of Auditors
S No. Department Date of Audit Auditor
1 Lab Management
2 Reception
3 Sample Collection
4 Stores & Purchase
5 Reporting / I.T
6 Maintenance
7 Housekeeping
8 Clinical Biochemistry
9 Hematology
10 Clinical Pathology
11 Serology
Areas Audited
17. S No. Department
No. of
NC
Clause /
Procedure
Violation
Target
Date
Responsibility
1
2
3
4
5 Total No. of Nonconformance
19. PERSON
ATTENDED
SIGN PERSON
ATTENDED
SIGN
Medical Director I/C Biochemistry
Lab Director I/C Hematology
Quality Manager I/C Clinical Pathology
I/C Reporting I/C Serology
I/C Reception I/C Sample Collection
MANAGEMENT REVIEW MINUTES
REPORT NO. DATE OF MEETING:
PLACE TIME: From ______ to _______ hrs
20. S
No
AGENDA POINTS DISCUSSED
Action
Taken
, If Any
Responsibility /
Target Date
Action
Verified By
a Periodic review of requests, and suitability of procedures and
sample requirements
b Assessment of user feedback
c Staff suggestions
d Internal audits
e Risk Management
f Use of Quality Indicators
g Review by external organizations
h Results of participation in inter-laboratory comparison
programmes (PT/EQA)
i Monitoring and resolution of complaints
j Performance of suppliers
k Identification and control of nonconformities
l Results of continual improvement including current status of
corrective actions and preventive actions
m Follow up actions from previous management reviews
n Changes in volume and scope of work, personnel and premises
that could affect the quality management system
o Recommendation for improvement, including technical
requirements
MINUTES OF MRM POINTWISE
21. DAILY NON CONFORMANCE REPORT
MONTH
Department Date..
Management
Administration
Sample Collection Area
Sample Processing Area
Sample Testing Area
Reporting / IT
Done By
22. Management: Lab Director / TM / Q Mgr
Administration: Reception, Housekeeping / BMW,
Maintenance, Stores
Sample Testing Area: Biochemistry, Hematology, Clinical
Pathology, Serology, Microbiology
Category of Nonconformance
1 Customer Complaint, 2 Procedure Violation
3 Product Quality 4 Service Quality,
5 Environment Related, 6 Equipment Related,
7Staff Related, 8 Housekeeping
9 Sampling Related, 10 Others (Pl Specify)
Any Non conformance repeated after taking corrective action in the
past ? YES NO
23. DAILY NON CONFORMANCE REPORT
DATE DEPARTMENT
DETAILS OF DAILY N C R
ROOT CAUSE
CORRECTIVE / PREVENTIVE ACTION TAKEN TARGET DATE RESPONSIBILITY
CLOSURE VERIFICATION
DATE DEPARTMENT
DETAILS OF DAILY N C R
ROOT CAUSE
CORRECTIVE / PREVENTIVE ACTION TAKEN TARGET DATE RESPONSIBILITY
CLOSURE VERIFICATION
24. PREVENTIVE ACTION FORM
DEPTT DATE
DEPARTMENT INCHARGE
PREVENTIVE ACTION SUGGESTED
NAME
SUGGESTION
PREVENTIVE ACTION ACCEPTED NOT
ACCEPTED
PREVENTIVE ACTION PROPOSED TARGET DATE
RESPONSIBILITY
ACTION TAKEN VERIFICATION REMARKS OF LAB DIRECTOR
26. QUALITY INDICATORS FOR MONTORING LABORATORY’S PERFORMANCE
(Year )
MONTH
QUALITY INDICATORS 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15
PRE ANALYTICAL FAILURES
Syntax errors during patient registration
No. of veni puncture failures
No. of Sample Rejections
No. of times samples marked URGENT reached late for
testing
ANALYTICAL FAILURES
No. of Re Test on patient / clinician request
No. of times alert values not informed to Ref. doctor
No. of equipment failures
No. of parameters with IQC outside good % CV (Monthly)
No. of parameter outside the EQAS acceptable criteria
POST ANALYTICAL FAILURES
Reports not delivered on time (TAT)
No. of reporting errors
No. of complaints received from clinicians
No. of complaints received from patients / attendants
Done By
27. QUALITY INDICATORS FOR MONTORING LABORATORY’S PERFORMANCE
(Year )
Quality Indicators - Cumulative Score – Month wise
QUALITY INDICATORS JAN FEB MAR APR MAY JUN JULY AUG SEP OCT NOV DEC
PRE ANALYTICAL FAILURES
Syntax errors during patient registration
No. of veni puncture failures
No. of Sample Rejections
No. of times samples marked URGENT reached late for
testing
ANALYTICAL FAILURES
No. of Re Test on patient / clinician request
No. of times alert values not informed to Ref. doctor
No. of equipment failures
No. of parameters with IQC outside good % CV (Monthly)
No. of parameter outside the EQAS acceptable criteria
POST ANALYTICAL FAILURES
Reports not delivered on time (TAT)
No. of reporting errors
No. of complaints received from clinicians
No. of complaints received from patients / attendants
Done By
28. REFERENCE LAB EVALUATION
Duration of Performance Evaluation
Year
Name of Ref Lab
January – June July – December
COMPLAINTS AGAINST
1 Delay in Pick up of Samples
2 Non standard method of transportation
3 Wrong Patient / Test Entry
4 Delay in Delivery of Reports
5 Behavior of Ref Lab Staff
6 Errors in billing
7 Improper Communication
8 Refusal to give urgent reports over phone
Overall Rating
Evaluation Done By
Verified By
Yearly Performance Rating
29. CRITERIA OF EVALUATION
RATING
10 or more complaints C
5 or more complaints B
Less than 5 complaints A
ACTION TAKEN
A Recommend for continuation
B Suggestion For improvement
C Warning (Discontinue if the supplier gets two consecutive rating)
30. INCIDENT / ACCIDENT REPORTING FORMAT
Date:
Department
Person Involved
Category of Accident / Incident – Please “ √ ” on relevant category
Needle
Stick
Injury
Spills &
Splashes
Falls &
Slip
Fire Electrical Chemical Infrastructure Physical Others
Details of Accident / Incident
Root Cause
Corrective Action Taken
Responsibility
Acton Verified By / Date
31. DOCUMENT DISTRIBUTION RECORD
Documents
Quality Manual
(QM)
Quality system
Procedures
(P&P)
Standard Operating
Procedures (SOP’s)
Forms and
Formats
(FR)
Equipment
Operating Manuals
{OM) Kit Inserts
Sample
Collection
Manual
LISTS
Recd
By
Issued To
Department
In-charge
Date
Lab Director
Copy No.1
CopyNo.1 ALL Copy No-1 ALL Copy No.1 ALL
TM
CopyNo.2
Soft copy
CopyNo.2
Soft Copy
ALL CopyNo.2
Soft copy
ALL Copy No.2 ALL
Q Mgr
CopyNo.2
Soft copy
Copy No.2
Soft Copy
ALL CopyNo.3
Soft copy
Copy No.3
NABL Copy No.3&4
Hospital
Management
Copy no. 5
Reception (Relevant) Copy No.4 (Rate List)
Sample Collection (Relevant) (Rate List)
Biochemistry
Biochemistry SOP
Copy No.4
(Relevant)
Mispa- Nano,
Erbachem/Smartlyte
/
Kit Insert
Hematology
Hematology SOP
Copy No.4
(Relevant) XP-100/Kit Insert
Clinical Pathology
Clinical Pathology
SOP Copy No.4
(Relevant) Kit Insert
Serology
Serology SOP
Copy No.4
(Relevant) Kit Insert
IT / Reporting (Relevant)
Maintenance (Relevant)
Housekeeping (Relevant)
32. AGREEMENT– PART TIME CONSULTANT
I, Dr _______________________MD (Path / Micro) agree to visit Global Diagnostic
Laboratory, Bhatia Global Hospital & Endosurgery Institute, New Delhi for the following
activities between ____ to ___ in the morning and between _____ to ____in the evening or
whenever requested during emergency.
•Monitor the functioning of department / Lab and the staff for various procedures and
protocols.
•Verify the QC for the activity done by the technicians
•Verify correct documentation and transmission of patient data in microbiology department /
lab
•Verification and Signing of final test reports
As a laboratory consultant, I will also use my powers judicially for
•Controlling of nonconformance in the lab
•Rejection of samples / results / items found nonconforming
•Ask for a repeat test wherever required
•Send the samples to external lab for cross verification if required
•Follow EQAS and ILC program for necessary corrective actions
I also agree to keep all the lab information confidential and will take necessary actions with
impartiality and without any internal, external, commercial, financial or any other influences
that may adversely affect the quality of work.
This agreement will be reviewed as and when the need arises on mutually acceptable basis
33. RISK ASSESSMENT FORM
Risk Assessed – During or Due to 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16
Registration
Sample - Collection, Processing,
Transport & storage
Equipment - Operation, Maintenance &
Calibration
IQC / EQAS - Preparation, Use, Storage
& CAPA
Reagent - Use & Storage
Maintenance - Work Environment, Power
Supply & Backup
Housekeeping - Cleaning, Dis-infection,
disposal
Staff - Competence & Training
Result / Data - Confidentiality,
Transmission, Reporting, Release &
Storage
Done By
MONTH
34. RISK ASSESSMENT FORM
DATE NAME OF PERSON LOCATION
RISK IDENTIFIED
RISK LEVEL: HIGH MODERATE LOW
ACTION TAKEN FOR RISK MANAGEMENT
ACTION TAKEN BY ACTION EFFECTIVENESS VERIFIED BY
DATE NAME OF PERSON LOCATION
RISK IDENTIFIED
RISK LEVEL: HIGH MODERATE LOW
ACTION TAKEN FOR RISK MANAGEMENT
ACTION TAKEN BY ACTION EFFECTIVENESS VERIFIED BY
35. SERVICE AGREEMENT DEVIATION FORMAT
Date
Patient
ID
Reason for Deviation
Details of
Deviation
Action
Taken
Consent
Taken By
Eqpt Method Kit Sample
User’s
Request
Others
36. ADVISORY SERVICES FORMAT
Date
Advise Given To
C: Consultant
P: Patient
A: Attendant
Patient
Name or ID
No
Type of
Advise
Given
Details of
Advise
Given
By
Verified By
TYPE OF ADVISE GIVEN
1Choice of examinations 2 Facilities provided by the lab and how to avail the same
3 Delivery of test report 4 Addition of examination 5 Choice of test methods 6 Patient
preparation requirements 7 Informed Consent 8 Type and volume of sample required for
examination 9 Collection methodology 10 Clinical indications and limitations of
examinations 11 Frequency of requesting the examination 12 Advising
on individual clinical cases 13 Professional judgement on the interpretation of
the results of examinations 14 Consulting on scientific and logistic matters such
as instances of failure of sample(s) to meet acceptance criteria 15 Others
37. EMPLOYEE PERSONNEL RECORD
Please affix your
photograph here
NAME
DATE OF BIRTH
PERMANENT ADDRESS
PRESENT ADDRESS
TELEPHONE NO.
DESIGNATION
DEPARTMENT
MONTH / YEAR OF JOINING
TOTAL PREVIOUS EXPERIENCE (Please give below the details)
1
2
3
4
5
QUALIFICATION
I hereby confirm that the details given above are correct to the best of my knowledge and
belief. The organization has the right to take any action that they deem fit against any wrong
information given by me
38. EMPLOYEE JOINEE FORM
Please affix your
photograph here
NAME:
FATHER’S NAME:
ADDRESS:
PHONE NO.
DEPARMENT
DESIGNATION
SALARY
DUTY TIMINGS
PROBATION / TRAINING PERIOD
SECURITY DEPOSIT:
(If Applicable)
I agree to the terms and conditions of employment and will abide
by all laboratory rules, regulations and procedures.
39. CONFIDENTIALITY AGREEMENT
IT IS HEREBY AGREED that:
I will work in laboratory – Hospital /Lab, New Delhi with full dedication, sincerity and within the framework of
professional code of ethics and guidelines given in procedure manual
During my association with HOSPITAL/LAB, I will not undertake outside assignments or do private work that
may create potential conflict of interest unless otherwise agreed with the management of Hospital/Lab.
I will execute all my responsibilities as defined in the procedure manual and will not refuse any other
responsibilities given to me by the management during urgent / emergency conditions
I will strictly follow all laboratory Rules, Regulation, procedures and instructions as given in various the
procedure manual in letter and spirit to avoid potential conflict of interests.
I will conduct all my activities with impartiality and without fear from any internal, external, commercial,
financial and other pressures that may adversely affect the quality of work
I will strictly adhere to all legal and statutory guidelines defined by the Central/ State Government of India and as
given in procedure manual
I will not do any activity that would diminish the confidence in my competence, impartiality, judgement or
operational integrity
I will work towards achieving short and long term goals and objectives set by the laboratory
I will develop, conduct and participate in staff training programs as per the training plan given by the management
or whenever instructed
I will not use Hospital /Lab name as surety / guarantee for taking personal loans etc
I will maintain strict confidentiality of laboratory and patient information / data
I will ensure proper safeguard against damage / loss / misuse of laboratory property directly under my supervision
/ department
Signature of Employee Signature of Lab
Director
Name Name of the Laboratory
40. EMPLOYEE HEALTH RECORD
Date of Examination
Name
Height cm
Weight
Kg
Sex Age Yrs
Nationality Marital Status
History of any significant past illness including: -
1) Psychiatric and neurological disorders (Epilepsy, depression)
2) Allergy
3) Others
MEDICAL EXAMINATION
RESULTS LABORATORY INVESTIGATIONS RESULTS
Eyes Lt. Urine: - Sugar
Eyes Rt. Blood Group
Color Blindness Haemoglobin
Pulse
Vaccination
(Hepatitis)
Date of
Vaccination
Heart Rate Blood.Pressure
1st Dose Lot No.
Expiry
Lungs
Chest X-Ray
2nd Dose Lot No.
Expiry
Hernia Venereal Disease
3rd Dose
Lot No.
Expiry
Deformity
Anti HhsAg
41. INDUCTION TRAINING FORMAT
Employee Name Date of Joining Department
Designation
ACTIVITY COVERED DATE
Accompanied
By
Employee’s
Sign
INTRODUCTION
Welcome by Quality Manager & introduction with person
who will accompany for induction training round
Quality Manager
Introduction with Lab management
Introduction to various departments in-charges and team
Brief about lab and management
Lab Timings
LAB PREMISES ROUND
Round of work area
Quality Manager
Location of toilets
Entrance & Exits of building
Fire Escapes & Location of fire fighting equipments
Layout of departments, equipments and other infrastructure
Brief on health & safety issues including vaccination
COMMUNICATION
Methods, Protocol Quality Manager
42. Location of Notice Boards
Schedule of Team Meetings
Protocol of communication over phone
KEY POLICIES & PROCEDURES
Financial rules & regulations
Quality Manager
Annual staff review, competency assessments and audits
Training Schedule
Other employment related policies
Staff benefits
WORK ETHICS
Working hours, Punctuality
Quality Manager
Lunch Break
Leave Policy
Absence
Complaints & Disciplinary Procedure
Pay day, Deductions etc
EMPLOYEE DEPARTMENT INDUCTION TRAINING
Maintenance
43. Welcome to the department
Department
In-charge
Introduction to department & department staff
Department Functions
Key duties & responsibilities
QMS & NABL awareness
Training on department equipment / procedures
Training on Computer, Software and LIS
Standard of work expected
Conduct
Confidentiality Issues
Handling complaints
Training on department SOP’s, Guidelines & Procedures
Training on Quality Assurance
ACTIVITY COVERED
DATE ACCOMPANIED
BY
Employee sign
Department:-
Biochemistry/Hematology/serology/clinical pathology
Introduction to Equipment
QC Procedure
EQAS
Biological Reference Intervals
Critical/Alert Values
REMARKS OF QUALITY MANAGER
44. ANNUAL TRAINING PLAN
YEAR
S
No.
TOPIC OF TRAINING FACULTY JAN FEB MAR APR MAY JUNE JULY AUG SEP OCT NOV DEC
1 QMS / NABL Awareness & Update
2 System Documentation
3 QC, EQAS and ILC
4 Good Housekeeping
5 Lab Safety and precautions
6 Fire Safety
7
Precautions during handling of blood
and body fluids
8 Sample Collection – Order of Draw
9
Customer confidentiality and
satisfaction
10 Biological Reference Range
11
Test Methodology and their
utilization
12 Test Interferences
13
Critical Values of various test
parameters
14 Sample Stability and Storage
15 Waste Disposal
16 Equipment operation & maintenance
17
Importance of timely sample
collection & delivery of reports
18 Others
45. TRAINING NEED IDENTIFICATION
To: Q Mgr
The following persons are required to be trained for the following
SUBJECT:
S No Employee Name Designation Reason for Training Requirement
Approved by Lab
Director
YES NO
1
2
3
4
5
6
7
8
9
10
46. MEETING / TRAINING ATTENDANCE SHEET
Date
Topic
Faculty
Participants
S No. Participants Name Designation / Specialty Sign Remarks Marks
48. EMPLOYEE TRAINING RECORD
Name; Department Year
Date Topic of Training
Duration
(In Hrs)
*Method
of
Training
Verified
by Q
Mgr
Results
* 1) Demonstration, 2) Presentation, 3) Assistance, Hands On 4)
Written Test
+ If the lab staff gets less than 75% marks in the test questionnaire post
training, s/he will be provided retraining on the same
49. EMPLOYEE SUGGESTION FORM
Employee Name
Date
Department:
Designation:
Details of Suggestion Given
Benefits to lab
Suggestion Accepted No Accepted
If accepted then implementation date
Suggestion
Review Date Reviewed By
Comments
Sign of employee
Sign of lab director
50. EMPLOYEE COMPETENCY ASSESSMENT FORM
Name Designation Department
S
No
ASSESSMENT
DATE
ACTIVITYASSESSED
Applicable to
T – Technical
NT – Non Technical
1 2 3 4 5
Assessment
Done By
1
Equipment Operation &
Maintenance
T, NT
2 Test and Equipment Calibration T
3 Equipment De contamination T
4 Equipment IQ, OQ & PQ T
5 Department SOP’s & P&P’s T
6 Department Documents & Records T, NT
7 Test Performance Characteristics T
8
Test Verification & Validation
Protocols
T
9 IQC, Analysis & CAPA T
10 EQAS / ILC, Analysis & CAPA T
11 Alert Values T
12 Patient Registration NT
13 Patient Identification T
14 Patient Preparation T
15 Order of Sample Draw T
51. 16 Addition & / or deletion of Tests T
17 Sample Collection T
18 Sample Transportation T
19 Handling URGENT Sample T
20 Sample Storage & Disposal T, NT
21 Sample Acceptance & Rejection Criteria T
22 Advisory Services T, NT
23 Quality Indicators T, NT
24 Environmental Compliance T, NT
25 Reagent & Consumables T
26 Password & Access Rights T, NT
27 Data Revision, Backup & Storage T, NT
28 Biomedical Waste Management Rules T, NT
29 Housekeeping T, NT
30 Storage of Reagents, Chemicals, Consumables T, NT
31 Universal Precautions T, NT
32 Lab Safety T, NT
33 Fire Safety T, NT
34 Handling Needle Stick Injury T
35 Handling Sample Spill T, NT
TOTAL MARKS
ASSESSOR’S COMMENTS
Sign of Employee Sign of Assessor
Acceptance Criteria: 60% marks
52. EMPLOYEE PERFORMANCE APPRAISAL FORM
STAFF NAME DEPARTMENT YEAR
S.
No
REVIEW PARAMETERS
SCORE
(Max:10)
1 Punctual and follow dress code
2 Reliable, Trustworthy and Disciplined
3 Alert and well informed regarding department functions and responsibilities given
4 Works as a team with other lab staff and management
5 Displays leadership qualities
6 Well behaved and good communication skills (verbal, written and over telephonic)
7 Projects positive image of the organization to patients and external customers.
8 Follows organizational and departmental processes / protocols / policies
9 Willing to takes initiative if situation demands
10 Understands and interprets department quality indicators well and work towards
improvement of the same
11 Follow good laboratory practices, lab safety protocols and ethical practices of the lab
12 Handling of department instruments, equipments and timely updates of department
records
13 Completes work as per schedule given
14 Errors committed during performance of duty
15 Regular participation in training programs
TOTAL SCORE
53. OUTSTANDING VERY GOOD GOOD NEEDS
IMPROVEMENT
120 or more 100 – 120 80 – 100 Less than 80
OVERALL RATING CRITERIA
•Minimum acceptable overall score 80
•Lab staff getting less than 80 shall be counseled for improving the performance
Employee Sign Quality Manager Sign Appraiser’s Sir
54. SUPPLIER REGISTRATION FORM
Name of the company
Address
Phone Fax E Mail
Name of the Contact Person
The Company is having distributorship of the following companies
1
2
3
4
5
Credit Limit offered
Delivery schedule of various items
Clients of repute 1
2
3
4
5
Past experience in medical industry
Details of discounts / schemes offered
For office use only
Criteria for approval 1 Past Experience
2Recommendation from present clients
3Proximity to our Laboratory
4ISO Certified Company
5Credit Limit
6Discounts / Schemes offered
Remarks
55. SUPPLIER PERFORMANCE RECORD
Supplier Name Duration
Total Number
of challan /
bills received
Criteria for evaluation Wrong Item
were supplied
Wrong Brand /
Specifications
was supplied
Supply was
Delayed
Items were rejected due
to leakage, breakage,
packing, transportation
method, Short Expiry
Wrong Billing
was done
Total
Violation
No. of Bills / Challans
where
Bill / Challan No & Date
Reason for violation
Reason Accepted /
Rejected
Overall Grade Recommended
Done By Verified By
Performance Evaluation Criteria: A – Less than 5 violations, B – Between 5 – 10 violations , C - More than 10
violations
Action to be taken A – Recommendation B – Request for improving the services C - Warning
57. STOCK REGISTER
ITEM MINIMUM STOCK LEVEL
Date Supplier. Bill / Challan No.
Incoming
Inspectio
n Done by
Qty
Recd
Expiry Lot No.
Qty.
Issued
Issued
To
Balanc
e
58. HOUSEKEEPING SCHEDULE
ACTIVITY FREQ 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31
FLOORING 2 X D
CLEAR
DUSTBINS 2 X D
TABLES
D
CHAIRS
D
Workbench
Hypo Cleaning D
Windows
W
Racks
W
Tube lights
F
Fans
M
Cabinets
M
OTHERS
AR
DONE BY
VERIFIED BY
D – Daily W – Weekly F – Fortnightly M – Monthly AR – As Required
62. INTERNAL COMPLAINT FORM
Employee Name
Date
Department:
Designation:
Complaint Reviewed By
Action Taken By
Complaint Related To (Please √ tick )
Working Condition Infrastructure Equipment Staff Job Resp Misbehavior Facilities
Others
Details of Complaint
Reason for such complaint
Action Taken
63. CRITICAL / ALERT VALUE INFORMATION FORMAT
Dat
e
Seri
al
No.
OPD /
IPD
No.
Patient Name
Ref By
Dr.
Report
Alert Value
Sampl
e
Receiv
ing
Time(S
RT)
Inform
ation
Time
Informed
To
Doctor
Sign
of
Person
Inform
ing
•All Alert Values to be informed within 30 minutes of test results
64. SAMPLE REJECTION FORMAT
Date
Patient
ID No.
Sample Rejected Fresh Sample Recd
Reason for Rejection
Informed
To
Time of
Fresh
Sample
Recd
Blood Urine Stool Sputum
Body
Fluid
Semen Other
EXTERNAL QC CORRECTIVE ACTION RECORD
Date:
Name of EQAS Program: Month / Cycle No.:
Test Parameter in Outlier:
Result:
Acceptable Criteria: SDI / Z SCORE: Within + / - 2,
Root Cause Analysis for outlier: “ √ ” mark the reasons given below which
may have contributed to result outlier
66. INTERNAL QC CORRECTIVE ACTION RECORD
DATE
TEST
PARAMETER
OUTLIER
EQPT
ACTION
TAKEN
REMARKS
Sign of
Tech
Sign
of
TM
Daily QC Out /
Monthly % CV high or
Westgard Rule
Acceptance Criteria: Daily QC value within range specified by
manufacturer for that control
No Westgard rule violation
Monthly % CV:- < 5 % for Hematology and < 10 % for
Biochemistry OR < last year highest %CV whichever is higher
71. DECONTAMINATION SCHEDULE EQUIPMENT
Equipment Contamination
DAILY
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16
All Pipettes
All Timers
All Thermometers
Done By
Verified By
Equipment Contamination
WEEKLY
Date/Initial Date/Initial Date/Initial Date/Initial
Date/Init
ial
All Centrifuges
All Incubators
Equipment Contamination
MONTHLY
Date/initial
All Refrigerators
All Microscopes
Equipment Contamination
QUARTERLY
Date/initial
BS 200
ERBACHEM 7
SMARTLYTE
XP 100
72. EQUIPMENT LOG BOOK FORMAT
Equipment Name:
Date
Machine
Start Up Time
Operator’
s Sign
Remarks if any
Machine
Shut Down Time
Operator’s
Sign
Remarks if any
