A.General
1. Room
temperature & humidity log
2. Microscope
daily maintenance log
3. Daily
maintenance log for CO2 incubator
4. Daily
maintenance log for incubator
5. Incubator
daily temp. record log
6. Daily
maintenance log for water bath
7. Refrigerator
temperature log
8. Freezer
temperature log
9. Daily
maintenance log for centrifuge
10. Daily
maintenance log for barcode printer
11. Daily cleaning
record of the working area
12. Daily cleaning
record of washroom(s)
13. Sample
rejection log
14. Critical value
log
15. Software
validation record log
16. Inter-lab
comparison record log
17. Deep freezer
defrost log
18. Carryover
evaluation record log
19. Audit NC
record log
20. Corrective
action record log for IQC outlier
21. CA-PA log for
errors
22. Instrument
breakdown log
23. Inter-personnel
validation record log
24. Read &
understood record log
25. Result
amendment record log
26. CA-PA log for
EQAS/ILC outlier
27. CA-PA log for
monthly CV% outlier
28. Inter-instrument
/ method comparison log
29. Lot
verification record log
30. Monthly CV%
record log
31. Training / CME
attendance log
32. Daily
temperature log for hot air oven
33. Instrument
authorization record log
34. Maintenance
log for water system
35. Competency
assessment record log
36. Employee
feedback record log
37. Split testing
record log
38. Fumigation
record log
39. Housekeeping
record log
40. Vendor
evaluation record log
41. Reagent usage
record log
42. Adverse
incident record for reagents log
43. Sample discard
record log
44. Preparation of
1% sodium hypochlorite record log
45. LIMS request
record log
46. Specimen label
correction record log
47. Specimen of
not received follow-up record log
48. Glassware
residual checking record log
49. Verification
of formula calculated test results record log
50. Slide discard
record log
B)
Department wise required logs will be prepared as required based on the final
test scope.
5.Checklist awareness training to all
levels of employees within the laboratory.
·
Training
on ISO 15189:2012
o
All
15 sub-clauses of management requirements.
o
All
10 sub-clauses of technical requirements.
·
Training
on NABL 112
·
Training
on assessor checklist 1
o
Clause-wise
requirement of documents.
o
Clause-wise
implementation.
·
Training
on assessor checklist 2
o
Clause-wise
requirement of documents.
o
Clause-wise
implementation.
·
Training
to designated quality manager, deputy quality manager and department wise key
personnel on facing the audits.
o
6.Checklist development and effective implementation of
processes in laboratory
·
Pre-Analytical:
Patient Preparation, Sample Collection, Transportation, Accession, Cross
Verification, and Separation.
·
Analytical:
Sample Received, Work List, Processing, Report Entry, Validation, and Approval.
·
Post-Analytical:
Report Generation, Report Printing, and Report Delivery
7. Step will provide a customized
checklist for conducting an internal audit, which includes required
details/records each clause mentioned in ISO 15189: 2012.
8.Guidance in Conducting management
review meeting in presence of “laboratory top management” to guide the
laboratory for effective implementation on all the issues related to management
requirements and technical requirements of ISO 15189:2012.
List
of procedure
1.Receipt,
handling, storage and disposal of samples in line with the legalrequirements
2.
Control of documents
3.Establishment
and review of agreements for providing medical laboratory servicesto its customers
/ patients
4.
Selecting and evaluating referral laboratories and consultants
5.
Purchasing
6.Management
of complaints or other feedback received from clinicians, patients,laboratory
staff or other parties
7.
Identification and control of non–conformities
8.
Corrective action
9.
Preventive action
10.
Control of records
11.
Internal audit
12.
Management review
13.
Personnel and training
14.
Facility maintenance and environment
15.
Selection, purchasing and management of equipment
16.Safe
handling, transport, storage and use of equipment to prevent itscontamination
or deterioration
17.
Calibration of equipment
18.Reception,
storage, acceptance testing and inventory management of reagentsand consumables
19.
Pre–examination process
20.
Collection and handling of primary samples
21.
Transportations of samples
22.
Sample receipt
23.
Pre–examination handling, preparation and storage
24.
Validation of examination procedures
25.
Ensuring the quality of examination results
26.
Review of examination results
27.
Identification, collection, retention, indexing, access, storage, maintenance
and safe disposal of clinical samples
28.
Reporting the results
29.
Release of examination results
30.
Confidentiality of patient’s information
List of
standard operating procedure (SOPs)
1.
Collection & Transport of Specimens for Biochemistry Examinations
2.
Patient Preparation Instructions
3.
Needle Stick Injury – Care & Precaution
4.
Specimen Acceptance & Rejection Criteria
5.
Treatment and Disposal of Biomedical Waste
6.
House Keeping Procedure
7.
Personnel Safety Procedure
8.
Sample Preparation and Storage
9.
Sample collection
10.
Sample rejection
11.
General departmental procedure
12.
Quality control procedure
13.
Equipment maintenance & operating procedure
14.
Measurement of Uncertainty
15.
Monitoring Turn-Around-Time
16.
Critical Alert Level Values / Panic Values
17.
Repeat Test
18.
Data backup plan
19.
Generation of test results
20.
Housekeeping
21.
Personal protection and safety
22.
Treatment and Disposal of Biomedical Waste
23.
Data backup plan, Linearity and range of testing, Accuracy& Precision
24.
Equipment calibration plan procedure
25.
Test procedure – Serum – Alanine Amino Transferase Cobas c501
26.
Test procedure – Serum – Albumin – Cobas c501
27.
Test procedure – Serum – Bicarbonate – Cobas c311
28.
Test procedure – Serum – Bilirubin Total – Cobas c501
29.
Test procedure – Serum – Calcium – Cobas c501
30.
Test procedure – Serum – Creatinine – Cobas c501
31.
Test procedure – Serum – GGT – Cobas c501
32.
Test procedure – Serum – Glucose – Cobas c501
33.
Test procedure – Serum – HDL Cholesterol – Cobas c311
34.
Test procedure – Serum – Phosphours – Cobas c501
35.
Test procedure – Serum – Aspartate Amino Transferase – Cobas c501
36.
Test procedure – Serum – TGL – Cobas c501
37.
Test procedure – Serum – Total Cholesterol – Cobas c501
38.
Test procedure – Serum – Total Protein – Cobas c501
39.
Test procedure – Serum – Urea – Cobas c501
40.
Test procedure – Serum – Uric Acid – Cobas c501
List of
Exhibits
1.
Skill Requirements
2.
Codification System
3.
Calibration Periodicity
4.
Secrecy Rules
5.
Recommended conditions for sample collection, transport and storage for
conventional cytogenetic analysis
6.
Minimum retention period for identified records
List of
Formats
1.
Accident / Incident Record
2.
Equipment Maintenance Breakdown Record
3.
Calibration Register - Clinical Chemistry
4.
PT / EQAS / ILC / corrective action report
5.
Critical Alert Results Register
6.
Equipment History Record
7.
Equipment Maintenance Log
8.
Housekeeping Record
9.
Kit in Use Log Form
10.
LJ chart Template for Lab Mean
11.
LJ chart Template for Product Insert Mean
12. Non Conformance Register
13.
Record Label
14.
Repeat Test Result Register
15.
Sample integrity register
16.
Sample Rejection Register
17.
Sample storage and discadal register
18.
Monitoring STAT
19.
Monitoring TAT
20. Temperature Log Form - Room
21.
Bleeding Time & Clotting Time Register
22.
Housekeeping Register
23.
Non Conformance Register
24.
Sample Collection Register
25.
Sample rejection Register
26.
Sample Rework Register
27.Temperature
Log Form – Room
28.
Request for examination – serum / fluorideplasma
29.
Request for examination – urine
30.
Request for examination – Serum
31.
Request for examination – whole blood / serum
32.
Request for examination – whole blood with EDTA
33.
Customer feedback form
34.
Complaint register
35.
Complaint report
36.
Inward register
37.
Test Instruction Slips
38. Final Test Report
39.
HIV Consent Form
40.
Test Amendments Form
41.
Training Calendar
42.
Training Report
43.
Induction training report
44.
Job Description and Specification
45.
Skill Matrix
46.
Confidentiality Agreement
47.
Appointment Letter
48.
Employees Competence Report
49.
ISO 15189 effectiveness check report
50. Employee history card
51.
Immunization report
52.
Equipment history card
53.Preventive
maintenance schedule
54.
Equipment wise preventive maintenancecheckpoints
55.
Disposal of non–conformities
56.
Purchase order
57.
Indent (purchase requisition)
58.
Approved vendor list cum open purchase order
59.
Supplier registration form
60.
Open purchase order
61.
Material specification sheet
62.
Evaluation for Referral Lab
63.
Stock register
64.
Supplier evaluation form
65.
Four Year Plan for Quality Control
66.
Re–test plan / execution report
67.
Z score report
68.
Uncertainty of Measurement
69.
Re - Test Analysis
70.
Critical consumables
71.
Environment condition monitoring report
72.
pH Meter Calibration Report
73.
Inspection report
74.
Normality record sheet
75.
Intermediate check report – weighing balance
76.
Intermediate check report – oven
77.Housekeeping
checklist
78.
Checklist for Medical Laboratory Collection Centre/ Facility
79.
Quality control plan method
80.
Design / Planning of the method validation
81.
Validation report
82.
Master List Cum Distribution List of Documents
83.
Change Note
84.
Corrective action report
85.
Master List of Records
86.
Quality objectives (key performance indicator)
87.
Audit Plan / Schedule
88.
Internal audit non–conformity report
89.
Clause wise document wise audit review report
90. Preventive Action Report
91.
Calibration status of equipment
92.
Audit Observation Report
93.
Goods inward register
94.
Stock register