Checklist of Pathology Laboratory and its quality indicators for NABH accreditation

preparation

Pathology lab is expected to provide as accurate diagnosis as possible, within reasonable time
frame and without compromising the safety of patient or its staff. To be able to do so, the lab is
required to follow certain policies and processes. The NABH standards outlines following
requirements for a medical laboratory in a hospital.

1. The Lab must be able to provide those tests that are required by various clinical
specialities offered by the hospital. For this, hospital must identify all tests required by
different specialities and provide necessary machines, materials and manpower to
conduct those tests.
2. A written document on scope of laboratory services shall be available. This is basically a
list of all tests that can be done in the laboratory. The list should updated from time to
time. 
3. In case some tests cannot be offered or is not available, an arrangement should be there
to outsource such tests to an external laboratory. In this case following things are
required to be ensured.
1. A list of all tests that can be outsourced should be prepared, specifying which
external lab (or labs) the tests can be outsourced to
2. In each of the external lab, identity of the coordinating personnel from that lab,
should be available in written
3. A standard process should be there on how to outsource the test. The standard
process must describe, the method of packaging of sample, labels and
identification on packet, sending of other necessary information such as tests
requested, and method of transportation of samples.
4. The selection of labs where the tests will be outsourced should be based upon
criteria of quality and safety. A policy of outsourcing only to NABL accredited lab
can be adopted, however, not mandatory. The selection criteria should be
available in written.
5. A written MoU should be signed with the outsourced lab, specifying the terms
and conditions related to quality assurance requirements
4. Standard operating process for carrying out each test procedure should be available in
written
5. Defined turn-around time for each test should be available in written
6. A list of tests for which informed consent is required (such as HIV tests), should be
prepared.
7. A documented process on ‘handling of critical finding’ should be available. The
document should list out those findings (test values) that should be considered as
critical and step by step process on what should be done, once a critical finding is found.
8. For quality assurance of lab tests following things is required to be done
1. Each test methods used in lab should be verified. For this each new batch of
reagents must be compared with the results of a defined number of tests done
with an earlier batch
 2. Any new test method or modification in standard method of testing should be
validated by qualified pathologist. The method should be certified by a qualified
pathologist as validated.
3. Internal quality assurance should be performed by conducting surveillance. A
sample of specimens should be re-checked by peers and findings should be
correlated.
4. Diagnosis of laboratory should also be correlated with diagnosis obtained
through imaging and clinical assessment diagnosis
5. External quality assurance should be done. Samples of specimens must be sent
to an external lab for testing and findings must be correlated
6. Minutes of meeting (or any other similar records) should be available to show
that external and internal quality assurance findings have been communicated,
discussed, analysed and actions has been taken
9. Each equipment in laboratory should have a calibration scheduled. This can be
documented in the equipment log. A calibration report / label on equipment should be
there as an evidence that calibration has been done, as per schedule
10. Each equipment should have a preventive maintenance schedule. This can be
documented in the equipment log. A record of preventive maintenance check carried
out should be available.
11. A register documenting all corrective and preventive action taken should be available
12. Following laboratory safety measures should be in place
1. A laboratory safety manual that describes all safety practices to be followed by
staff during work should be available
2. Personal protective gears such as aprons, gowns, gloves, eye covers etc. should
be available. Type of gears should be according to the risks to which staff is
exposed to while conducting tests.
3. A list of all hazardous chemicals being used and stored in laboratory should be
prepared and MSDS for each hazardous item must be available
4. Hazardous chemicals should be stored safely to prevent its accidental spillage
5. A spill management protocol (including blood spills) must be in place and things
required for cleaning spills should be available
6. A written guideline should be available for disposal of infectious bio-medical
waste
7. A representative from laboratory should be the member of hospital’s safety
committee (Refer safety committee under 'list of hospital committees and
teams')
8. Each staff should have been trained and are aware of laboratory safety practices.
Records of training and evaluation to be maintained
13. The staff should be aware of other topics which includes
1. Patients’ rights and responsibilities
2. Employee rights and responsibilities
3. Scope of services of hospital and of laboratory
4. Critical findings and what to do in those situation
5. Occupational health hazard that they are exposed to and how to prevent
 6. Basic life support and code blue procedure
7. Other emergency codes used in hospital, such as code red, code pink etc.
8. Standard precaution for infection prevention
9. Emergency evacuation plan
10. Their role during disaster situation.
11. Dealing with HIV +ve patients and maintaining confidentiality
12. Turn-around time and other quality indicators being used in imaging

 Quality Indicators: 

Following quality indicators must be used in imaging as a part of quality assurance programme.
Each doctor and staff should be aware of these indicator

1. % of test result delayed from standard turn-around time

2. % compliance to laboratory safety practices (done through sample monitoring)
3. % of critical results reported to concerned consultant within the given timeframe
4. % of variation in internal quality checks
5. % of variation in external quality checks
6. % of repeat samples required to be taken
7. % of re-testing done