1.Expired kits found in
the department refrigerator.
2.MU not determined for
the month of november 2008 for all
parameters in the scope of
3.Root cause analysis
not done for Eqas for the month of Jan
4.Records not easily
5.Internal Qc for
immulite system : suggested to run atleast one
level (Positive or negative control) with each
batch of patient samples in addition to running
the calibrator while calabrating the the
instrument with every new lot of
6.Internal qc for hba1c
is run once in 7 days at present.Suggested to
run Iqc daily using previous tested patient
sample and record it.
7.Quality control values
are not recorded for hb
8.Flame photometer is
not calibrated .All equipments used for testing
shall be calibrated before put into
9.Advia machine was
maintained in RT instead of 18 - 25 deg c which
is temperature it should be
to be maintained for each parameters incuding
the details of reagent and calibrator lot
,expiry , ,source in the calibration
11.Date of kit opened to
be marked on the packs.
12.kit inserts /
brochures do not bear -- Document of
external orgin seal.and no controlled copy seal
and effective date in kit
13.Body surface area and
height not included in the creatinine clearance
14.The date and time of
receipt of primary samples as well as the
identity of the receiving officer shall be
15.None of the
micropipettes are calibrated.There is no
facility for in house
16.Machine printouts of
calibration of D10 -HbA1c analyser are not
signed by the technician and no approval
signature of HOD.
calibration details for some of the manual test
performs special biochemical test by manual
method but not using certified glasswares which
quality of test results.
19.The software used to plot L J graph
is not validated.
20.The primary collection manual is
not prepared in accordance with Iso
21.The processed samples were not
stored in the refrigerator but discarded the
22.Performance specification for each
parameter has not been established.
23.Transport of primary sample from
nearby hospitals / labs not being monitored
with respect to time.
24.Laboratory has not established TAT
for each parameters listed in the scope of
25.The laboratory has not established
policies and procedures for release of reports
by telephone and mail service.
26.There is no external qc or ILC for
27.The balance which is used by the
biochemistry department is placed in the CP
department is not calibrated nor tracebel to
28.No fire extinguisher is available
in the department were the acids and chemicals
and inflammable chemicals has been stored.
29.Processed urine and serum
samples and kits are stored in the same
30.Bicarbonate is quantatively derived
from the parameters fron ABG analyser which is
not calibrated nor included in the list of
equipments and arterial blood parameters is not
included in the scope of test.
31.The waste disposal and segregation
pattern are not displayed in the department
were it is generated.
32.Equas results there are many
outliers for same parameters (Chloride) .The
lab has failed to monitor EQAS results.
33.In night duty reports being
generated when authorised signatory is not
available and signed by technician who is not
34.Kone lab instrument do not have
identy nor location details or calibration
details label on the instrument.
35.Frequency of Qc run on olympus
analyser is not according to NABL 112