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Forms and formats help for lab accreditation

Dr. Neeraj has provided a list of records and formats necessary to meet ISO standards for laboratories. The list includes over 50 documents across various areas like management, employees, equipment, quality control, audits and more. Standard operating procedures and formats are given for communication, document control, service agreements, evaluations, audits, training and more. The laboratory may use these suggested formats or modify them as needed and add more over time to maintain compliance with ISO standards.

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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 ………………………………………………..
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
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
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
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
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
FORMS AND FORMATS Prepared by Issued By Approved By Quality Manager Quality Manager Lab Director Name & Address of the Laboratory
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
INTERNAL AUDIT PLAN
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
INTERNAL AUDIT PLAN Area/Activity JAN 2016 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
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
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
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
S No. Department No. of NC Clause / Procedure Violation Target Date Responsibility 1 2 3 4 5 Total No. of Nonconformance
S No . Department No. of NC’s Closure Verification Remarks Date Status 1 2 3 4 5 6 Verification of Corrective Action taken by Q Mgr 7 AUDIT REMARKS
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
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
DAILY NON CONFORMANCE REPORT MONTH Department Date.. Management Administration Sample Collection Area Sample Processing Area Sample Testing Area Reporting / IT Done By
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
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
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
CONTINUAL IMPROVEMENT FORM DATE DEPARTMENT PREVIOUS STATUS IMPROVEMENT BENEFICIARY
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
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
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
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)
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
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)
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
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
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
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
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
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
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.
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
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
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
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
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
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
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
MEETING / TRAINING ATTENDANCE SHEET Date Topic Faculty Participants S No. Participants Name Designation / Specialty Sign Remarks Marks
TRAINING QUESTIONAIRE
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
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
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
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
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
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
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
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
PURCHASE ORDER Date Item orders with specifications Make / Model Qty Supplier Order Given By Approv ed By
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
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
TOILET CLEANING SCHEDULE TIME Date 8:00 AM 11:00 NOON 2:00 PM 5:00 PM Verified By
WASTE DISPOSAL RECORD Date Solid Waste Disposal Date Solid Waste Disposal Waste Qty {in Kg) Handed Over By Collected By Waste Qty {in Kg) Handed Over By Collected By 01 17 02 18 03 19 04 20 05 21 06 22 07 23 08 24 09 25 10 26 11 27 12 28 13 29 14 30 15 31 16
SAMPLE DISCARD RECORD MONTH: Department Samples Date PLAIN EDTA CITRATE FLOURIDE TOTAL Done By Verified By
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
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
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
Staff Related Equipme nt Work Environm ent Reagent Quality Quality Control Procedure / Instructio ns not followed Sample Degenerat ion problem Sample Reconstitut ion problem Sample Storage Lack of informati on FOR ALL “ √ ” ABOVE GIVE THE REASON THAT COULD HAVE CONTRIBUTED TO ERROR Corrective Action Taken Action Verified By
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
SAMPLE OUTSOURCED FORMAT S No . Lab No. Patient Name Age / Sex Tests Results Outsourced Lab Name Sample Given By Sending Time / Date Sample Recd By Report Recd By / Date Remar ks DATE
TEMPERATURE/ HUMIDITY RECORD Location Date 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 (M) (E) (M) (E) (M) (E) (M) (E) Done By Verified By Location Date 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 (M) (E) (M) (E) (M) (E) (M) (E) Done By Verified By •Acceptance Criteria: Fridge: 2ᴼC to 8ᴼC, Freezer: -10ᴼC to -20ᴼC, Room: 22ᴼC to 28ᴼC, Incubator: 37ᴼC +/- 2ᴼC, Humidity: 30% – 70% Morning: 8 – 9 am Evening: 5 – 6 pm
EQUIPMENT SERVICE LOG S No. Date of Complaint Equipment Nature of complaint Action Taken Equipment Working date Equipment Downtime
MAINTENANCE SCHEDULE EQUIPMENT Daily 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 Done By Verified By WEEKLY Date/Initial Date/Initial Date/Initial Date/Initial Date/Initial MONTHLY Date/initial Yearly AS NEEDED : REPLACEMENTS: Date/Initial Date/Initial
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
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
TEST REQUISITION SLIP PRINTED HOSPITAL FORMAT
FEEDBACK FORM–PATIENT 1 Name of Patient /Attendant Date: 2 Address/Tel no 3 Purpose of visit 4 Your rating of our Laboratory with regard to
FEEDBACK FORM CLINICIANS 1 Name of the Doctor Date 2 Name of the Hospital / Nursing home 3 Address 4 Your rating of our Laboratory with regard to
REPORT ERROR LOG FORMAT Date Patient ID Details of Error Reason Error Correction Done By Verified By Initial Corrected
Forms and formats help for lab accreditation

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Forms and formats help for lab accreditation

  • 1.
    Dr Neeraj ashas 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 ………………………………………………..
  • 4.
    S.No. Document NameCLAUSE 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 NameCLAUSE 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 NameCLAUSE 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 NameCLAUSE 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 NameCLAUSE 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 Preparedby Issued By Approved By Quality Manager Quality Manager Lab Director Name & Address of the Laboratory
  • 10.
    INTERNAL AUDIT PLAN Typeof 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
  • 11.
  • 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
  • 13.
    INTERNAL AUDIT PLAN Area/Activity JAN 2016 MAR 201 APR 201 MAY 201 JUN 201 JULY 201 AUG 201 SEP 201 OCT 201 NOV 201 DEC 201 LabManagement Reception Sample Collection Stores & Purchase Reporting / I.T Maintenance Housekeeping Clinical Biochemistry Hematology Clinical Pathology Serology
  • 14.
    DEPARTMENT DATE TIMEAUDITOR 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 CONFORMANCEREPORT 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 1Internal 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
  • 18.
    S No . Department No. of NC’s ClosureVerification Remarks Date Status 1 2 3 4 5 6 Verification of Corrective Action taken by Q Mgr 7 AUDIT REMARKS
  • 19.
    PERSON ATTENDED SIGN PERSON ATTENDED SIGN Medical DirectorI/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 CONFORMANCEREPORT 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 CONFORMANCEREPORT 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 DEPTTDATE 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
  • 25.
    CONTINUAL IMPROVEMENT FORM DATEDEPARTMENT PREVIOUS STATUS IMPROVEMENT BENEFICIARY
  • 26.
    QUALITY INDICATORS FORMONTORING 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 FORMONTORING 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 Durationof 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 10or 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 / ACCIDENTREPORTING 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 QualityManual (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 TIMECONSULTANT 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 RiskAssessed – 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 DATENAME 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 DEVIATIONFORMAT 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 AdviseGiven 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 Pleaseaffix 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 Pleaseaffix 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 ISHEREBY 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 Dateof 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 EmployeeName 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 NoticeBoards 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 thedepartment 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. TOPICOF 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 / TRAININGATTENDANCE SHEET Date Topic Faculty Participants S No. Participants Name Designation / Specialty Sign Remarks Marks
  • 47.
  • 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 EmployeeName 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 ASSESSMENTFORM 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 APPRAISALFORM 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 GOODGOOD 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 Nameof 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 SupplierName 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
  • 56.
    PURCHASE ORDER Date Item orderswith specifications Make / Model Qty Supplier Order Given By Approv ed By
  • 57.
    STOCK REGISTER ITEM MINIMUMSTOCK 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 FREQ1 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
  • 59.
    TOILET CLEANING SCHEDULE TIMEDate 8:00 AM 11:00 NOON 2:00 PM 5:00 PM Verified By
  • 60.
    WASTE DISPOSAL RECORD Date SolidWaste Disposal Date Solid Waste Disposal Waste Qty {in Kg) Handed Over By Collected By Waste Qty {in Kg) Handed Over By Collected By 01 17 02 18 03 19 04 20 05 21 06 22 07 23 08 24 09 25 10 26 11 27 12 28 13 29 14 30 15 31 16
  • 61.
  • 62.
    INTERNAL COMPLAINT FORM EmployeeName 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 / ALERTVALUE 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 IDNo. 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
  • 65.
  • 66.
    INTERNAL QC CORRECTIVEACTION 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
  • 67.
    SAMPLE OUTSOURCED FORMAT S No . Lab No. Patient Name Age/ Sex Tests Results Outsourced Lab Name Sample Given By Sending Time / Date Sample Recd By Report Recd By / Date Remar ks DATE
  • 68.
    TEMPERATURE/ HUMIDITY RECORD LocationDate 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 (M) (E) (M) (E) (M) (E) (M) (E) Done By Verified By Location Date 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 (M) (E) (M) (E) (M) (E) (M) (E) Done By Verified By •Acceptance Criteria: Fridge: 2ᴼC to 8ᴼC, Freezer: -10ᴼC to -20ᴼC, Room: 22ᴼC to 28ᴼC, Incubator: 37ᴼC +/- 2ᴼC, Humidity: 30% – 70% Morning: 8 – 9 am Evening: 5 – 6 pm
  • 69.
    EQUIPMENT SERVICE LOG S No. Dateof Complaint Equipment Nature of complaint Action Taken Equipment Working date Equipment Downtime
  • 70.
    MAINTENANCE SCHEDULE EQUIPMENT Daily1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 Done By Verified By WEEKLY Date/Initial Date/Initial Date/Initial Date/Initial Date/Initial MONTHLY Date/initial Yearly AS NEEDED : REPLACEMENTS: Date/Initial Date/Initial
  • 71.
    DECONTAMINATION SCHEDULE EQUIPMENT EquipmentContamination 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 BOOKFORMAT Equipment Name: Date Machine Start Up Time Operator’ s Sign Remarks if any Machine Shut Down Time Operator’s Sign Remarks if any
  • 73.
  • 74.
    FEEDBACK FORM–PATIENT 1 Nameof Patient /Attendant Date: 2 Address/Tel no 3 Purpose of visit 4 Your rating of our Laboratory with regard to
  • 75.
    FEEDBACK FORM CLINICIANS 1 Nameof the Doctor Date 2 Name of the Hospital / Nursing home 3 Address 4 Your rating of our Laboratory with regard to
  • 76.
    REPORT ERROR LOGFORMAT Date Patient ID Details of Error Reason Error Correction Done By Verified By Initial Corrected