BLOOD BANK INSPECTION CHECKLIST

(use separate sheets, if necessary)

(Collect specimen forms, documents, labels, record copies wherever necessary)
NAME OF THE INSTITUTION DATE OF INSPECTION
NORTH 24 PARGANAS
DISTRICT HOSPITAL 02.12.2019
BLOOD BANK
ADDRESS OF THE Jessore Road, Barasat, Kolkata 700 124.
INSTITUTION
TELEPHONE NUMBER 03325840268 / 8582845242
FAX NUMBER
E-MAIL
bloodbank.bdh@gmail.com
LICENCE NUMBER & DATE OF
ISSUE
DL 31 MB/SLA/CLAA/WB
INSPECTED BY CDSCO STATE DRUGS CONTROL

EXPERT (S) IF ANY

INSTITUTION REPRESENTED DR. SUMITRA HALDER, MOIC, BLOOD

BY
BANK
PURPOSE OF INSPECTION

Change of Premises

TYPE OF INSPECTION GOVERNMENT CHARITABLE RED CROSS OTHERS

(SPECIFY)

GOVERNMENT
CONSTITUTION DETAILS

PRODUCTS WHOLE HUMAN BLOOD, I.P.

TECHNICAL STAFF NUMBER QUALIFICATION EXPERIENCE
(ATTACH SHEET, IF (CHECK (CHECK
REQUIRED) DOCUMENT) TESTIMONIALS)
DOCTOR 03
COUNSELOR 02
REGISTERED NURSE 01
TECHNICAL SUPERVISOR 01
TECHNICIAN 07
PHARMACIST / STORE-IN-CHARGE 01
ATTENDANT 02
A TOTAL COLLECTION YEAR 2018 2019 till date
(Last Two calendar years) Voluntary 8744 8150
Replacement NIL NIL
Professional NIL NIL
TOTAL 8969 8150
DISTRIBUTION Used in Own 7276 6834
Hospital
Issued to others (Govt.) 501 (Govt.) 533
(Pvt.) 1192 (Pvt.) 1509
Discarded 246 168
B PREMISES TOTAL AREA
DETAILS OF AREAS COMMENTS
C REGISTRATION & MEDICAL 4.175 X 2.875 Ground Floor
EXAMINATION M Air Conditioned
D BLOOD COLLECTION (A/C?) Ground Floor
7.3 X 3.65 M
Air Conditioned
E SEROLOGY LABORATORY (A/C?) First Floor
7.25 X 3.525 M
Air Conditioned
F TRANSMISSIBLE DISEASES LAB First Floor
(A/C?) 7.25 X 3.0 M
Air Conditioned
G STERILIZATION & WASHNG First Floor
6.4 X 3.3 M
Non-Ac
H REFRESHMENT & REST ROOM Ground Floor
(A/C)? 3.6 X 3.6 M
Air Conditioned
I STORES & RECORD ROOM 6.35 X 4.4 M Ground Floor
6.35 X 4.4 M First Floor
2.475 X 2.5 M First Floor
COMMENTS ON AREA

C
J STANDARD BOOKS? (Obtain list) YES/NO/NA Separate Sheet Attached
K BLOOD BANK MANUAL YES/NO/NA Available
L STANDARD OPERATING PROCEDURES YES/NO/NA Available
M Criteria to determine donor suitability YES/NO/NA As per NBTC Guideline
N Method of donor selection YES/NO/NA As per NBTC Guideline
O Preparation of Phlebotomy site YES/NO/NA As per NBTC Guideline
P Product to donor traceability YES/NO/NA As per SOP
Q Collection procedures, precautions etc YES/NO/NA As per NBTC Guideline
R Method of components preparation YES/NO/NA Component Not Separated
S Test Methods YES/NO/NA As per SOP
T Pre – transfusion testing YES/NO/NA As per SOP
U Adverse reaction management YES/NO/NA As per SOP
V Storage temperature & its control YES/NO/NA As per SOP
W Expiry date assignment YES/NO/NA As per SOP
X Returned blood management YES/NO/NA As per SOP
Y QC for reagents & supplies YES/NO/NA As per SOP
Z Maintenance, calibration & validation of YES/NO/NA As per SOP
equipments
AA Labeling procedures YES/NO/NA As per SOP
BB Apheresis procedures YES/NO/NA Not Performed
CC Any other SOPs YES/NO/NA
DD Procedure for disposal of blood (expired, YES/NO/NA As per SOP
clotted, improperly collected, HIV + etc
EE Donor education / motivation material YES/NO/NA Available; supplied by GoWB,
number is not adequate
FF Donor selection YES/NO/NA As per NBTC Guideline
GG Donor record YES/NO/NA As per SOP
HH Selection / Rejection manual YES/NO/NA
II DONOR RECORD DETAILS
JJ AGE YES/NO/NA As per NBTC
Guideline
KK INTERVAL BETWEEN DONATIONS YES/NO/NA As per NBTC
Guideline
LL LAST PREGNANCY / DELIVERY / ABORTION YES/NO/NA As per NBTC
Guideline
MM IMMUNIZATION DETAILS YES/NO/NA As per NBTC
Guideline
NN RECENT DRUG INTAKE YES/NO/NA As per NBTC
Guideline
OO MAJOR SURGERY YES/NO/NA As per NBTC
Guideline
PP MALARIA YES/NO/NA As per NBTC Guideline
QQ JAUNDICE YES/NO/NA As per NBTC Guideline
RR OTHER VIRAL INFECTION YES/NO/NA As per NBTC Guideline
SS FEVER & COMMON COLD YES/NO/NA As per NBTC Guideline
TT HISTORY– CANCER, TB, DRUG, YES/NO/NA As per NBTC Guideline
DIABETES, ADDICTION, ETC
UU ALCOHOL INTAKE YES/NO/NA As per NBTC Guideline
VV Transfusion history YES/NO/NA As per NBTC Guideline
WW DONOR EXAMINATION
XX Weight YES/NO/NA As per NBTC Guideline
YY Venipuncture site YES/NO/NA As per NBTC Guideline
ZZ Haemoglobin YES/NO/NA As per NBTC Guideline
AAA Blood pressure YES/NO/NA As per NBTC Guideline
BBB Pulse YES/NO/NA As per NBTC Guideline
CCC Temperature YES/NO/NA As per NBTC Guideline
DDD COLLECTION OF BLOOD
EEE Preparation of Phlebotomy site YES/NO/NA As per SOP
FFF Type & amount of anti – coagulant used YES/NO/NA CPAD, 49ml
GGG Amount of Blood collected (random wt) YES/NO/NA 350 ml
HHH Blood collected in bags / bottles YES/NO/NA 350ml Single Bag
III Paediatric Bags? YES/NO/NA No
JJJ Is mixing done during collection. How? YES/NO/NA Manually
KKK Is new bag used in case of 2nd puncture YES/NO/NA
LLL How is sample tubes labeled? YES/NO/NA According to
Donor’s
Registration No.
MMM Emergency kit available YES/NO/NA
NNN STORAGE OF BLOOD
OOO Temperature recording graph preserved? YES/NO/NA
PPP Alarm system checks done? YES/NO/NA
QQQ Physical verification done? Frequency? YES/NO/NA Regularly
RRR How is blood transported? Outside; To Wards YES/NO/NA In temp. proof container
SSS BLOOD TESTING
a Sterility Testing YES/NO/NA

b Haemoglobin estimation method YES/NO/NA Cop. Sulfate

c Method for ABO grouping YES/NO/NA Slide / tube/Others.

Describe
d Procedure for grouping YES/NO/NA Slide / tube/Others.
Describe
e Method of pooled cell preparation YES/NO/NA

f Du test done on D – samples? YES/NO/NA

g Test for unexpected antibodies done? YES/NO/NA

Hepatitis test done? Describe method & name of kit YES/NO/NA ELISA Method
manufacturer
 h Syphilis test done? Describe method & name of kit YES/NO/NA Rapid Plasma Reagin
manufacturer Method
i HIV test done? Describe method & name of kit YES/NO/NA ELIAS Method
manufacturer
j HCV test done? Describe method & name of kit YES/NO/NA ELISA Method
manufacturer
Malaria test done? Describe method YES/NO/NA Rapid or Slide Smear
method
k Donor informed in case of + ve results YES/NO/NA Over telephone with
confidentiality
l In case of HbsAG/HIV +ve results. Donor debarred YES/NO/NA
permanently
m Are HbsAg +ve donors followed up? YES/NO/NA

TTT TESTING OF REAGENTS ETC.

a Antisera tested YES/NO/NA
b Method of antisera testing YES/NO/NA
c CPDA solution testing YES/NO/NA Test done by GoWB

UUU GENERAL EQUIPMENTS & INSTRUMENTS

a Refrigerator for blood storage: Type, capacity & number YES/NO/NA List attached

b Temperature records in refrigerator YES/NO/NA

c Audible alarm system in refrigerator YES/NO/NA

d Balance for bag weighing YES/NO/NA

e Autoclave with temperature & pressure display YES/NO/NA

f Incinerator YES/NO/NA

g Emergency power supply (generator) YES/NO/NA DG Set

h Donor beds, chairs, tables YES/NO/NA Adequate

i Bedside table YES/NO/NA Adequate

j Sphygmomanometer & stethoscope YES/NO/NA Adequate

k Recovery bed for donors YES/NO/NA Available

l Donor weighing scale YES/NO/NA Adequate

VVV EMERGENCY EQUIPMENTS

a Oxygen cylinder, mask, gauge & pressure regulator YES/NO/NA Available

b 5% Dextrose or Normal saline injection YES/NO/NA Available

c Sterile Disposable syringes & needles (various sizes) YES/NO/NA Adequate

d Sterile disposable I. V. sets. YES/NO/NA Adequate

e Adrenaline. Noradrenaline, Mehpentin, Betamethasone, (Or YES/NO/NA Adequate

dexamethasone), Metochlorpropamide injections
WWW ACCESSORIES
a Blankets, emesis basins, haemostats, set clamps, sponge YES/NO/NA Adequate
forceps, gauze, dressing jars, waste cans etc.
b Medium cotton balls, 1.25 cm adhesive tapes. YES/NO/NA Adequate

c Denatured spirit, Tinc, Iodine, green or liquid soap. YES/NO/NA Adequate

 d Paper napkins or towels. YES/NO/NA Adequate

XXX LABORATORY EQUIPMENTS

a Refrigerator for kits & reagents storage YES/NO/NA
Refrigerator make & capacity
Temperature display provided YES/NO/NA
b Compound microscope with low & high power objectives YES/NO/NA

c Table centrifuge YES/NO/NA

d Water bath – 37O - 57 O YES/NO/NA

e Rh viewing box YES/NO/NA

f Incubator with thermostat YES/NO/NA

g Mechanical shakers for serological test of syphilis test YES/NO/NA

h Hand lens YES/NO/NA

i Serological graduated pipettes of various sizes YES/NO/NA Adequate

j Pasteur pipettes YES/NO/NA Adequate

k Glass slides YES/NO/NA Adequate

l Test tubes of various sizes / micro plates YES/NO/NA Adequate

m Precipitating tubes (6 X 50 mm) of various sizes YES/NO/NA Adequate

n Test tube racks YES/NO/NA Adequate

o Interval timer YES/NO/NA

p Material & equipment for glassware cleaning YES/NO/NA Adequate

q Blood transporting containers YES/NO/NA

r Wash bottles YES/NO/NA Adequate

s Filter papers YES/NO/NA Adequate

t Dielectric tube sealer YES/NO/NA

u Plain & EDTA vials YES/NO/NA Adequate

v Chemical balance YES/NO/NA

w ELISA reader with printer, washer & micro – pipettes YES/NO/NA

x Colorimeters / haemoglobinometer (strike off which is not YES/NO/NA

applicable) for Haemoglobin determination
YYY RECORDS & REPORTS Comments, or Records, if any
a Blood stock register YES/NO/NA

b Blood donor record YES/NO/NA

c Issue register YES/NO/NA

d Record of blood bags YES/NO/NA

 e Cross matching records YES/NO/NA

f Register of diagnostic reagents & kits YES/NO/NA

g Adverse reaction records YES/NO/NA

h Stock register of other consumable articles YES/NO/NA

i Are records destroyed YES/NO/NA

j Labels of blood containers as per Schedule F of the “D” YES/NO/NA

& “C” act.
ZZZ OUTDOOR CAMPS
a Eligible to hold outdoor camps YES/NO/NA

b Average number of camps held per month YES/NO/NA Approx. 12/month

c Vehicle available? YES/NO/NA 1 BT Van

d How are blood bags transported? YES/NO/NA In insulated box

e Proof sanitary conditions of camps YES/NO/NA

f Detailed statement of blood collected in camps YES/NO/NA

g Detailed statement of blood collected in camps YES/NO/NA

MANUFACTURING OF BLOOD COMPONENTS FROM WHOLE HUMAN BLOOD

AAAA ACCOMMODATION / PREMISES YES/NO/NA COMMENTS
1. Does the blood bank have an area of 100 YES/NO/NA
square metres?
2. Does an additional 50 square meter area YES/NO/NA
provided for component preparation?
3. Does an additional 10 square meter area YES/NO/NA
provided for apheresis procedures ?
a Is blood component room is air conditioned? YES/NO/NA

b Is blood component room lighted, ventilated & YES/NO/NA

screened wherever necessary?
c Are walls & floors are smooth & washable? YES/NO/NA

d Is construction suitable for maintaining YES/NO/NA

hygienic conditions?
e Does uni – flow system exists? YES/NO/NA

f Any other area YES/NO/NA

g Total area YES/NO/NA

h Comments on area

BBBBPERSONNEL (Are the following whole time technical personnel provided for components / Apheresis?)
SN DESIGNATION NAMES QUALIFICATIONS EXPERIENCE
(Check the institute whether (Check attach
recognized) certificate)
1. Medical Officer

2. Registered Nurse
 3. Technical Supervisor

4. Attendant

CCCC EQUIPMENTS (As Per YES/NO/NA Make/Model/Capacity

(1) GSR 245 (E) dt 05 – 04 – 1999
i. Air conditioner YES/NO/NA

ii. Laminar air flow bench YES/NO/NA

iii. Suitable refrigerated centrifuge YES/NO/NA

iv. Plasma expresser YES/NO/NA

v. Clipper & clips & or dielectric sealer YES/NO/NA

vi. Weighing device YES/NO/NA

vii. Dry rubber balancing material YES/NO/NA

viii. Artery forceps, scissors YES/NO/NA

ix. Refrigerator maintaining a temperature between 2

O
YES/NO/NA
C to 6 O C a digital dial thermometer with
recording thermograph & alarm device, with
provision for continuous power supply
x. Platelet agitator with incubator (wherever YES/NO/NA
necessary)
xi. Deep freezers maintaining a temperature between YES/NO/NA
(-) 30OC to (-) 40OC & (-) 75OC to (-) 80OC.
xii. Refrigerated water bath for plasma thawing YES/NO/NA

xiii. Insulated blood bag containers with provisions for YES/NO/NA

storing at appropriate temperature for transport
purposes
xiv. Whether components are prepared only in a YES/NO/NA
closed system using single, double, triple or
quadruple plastic bags? YES/NO/NA
S 2 EQUIPMENT (GMP) YES/NO/NA COMMENTS
1. Are equipments located in logical sequence & YES/NO/NA
permit effective cleaning?
2. Are equipments calibrated / validated periodically? YES/NO/NA
3. Method of segregating defective equipments? YES/NO/NA
4. Is the logbook maintained for each equipments / YES/NO/NA
machine?

DDDD PREPARATION OF BLOOD COMPONENTS COMMENTS

1. Concentrated Human RBC’s YES/NO/NA
(Packed Red Blood Cells)
a Whether SOP is available for preparation of PRC?
SPECIFY: Source Material
Method
RCF
SPEED
TIME
b Is blood collected from suitable donor? (Check the YES/NO/NA
donor record)
c Are the packed red cells confirmed to the YES/NO/NA
standard of I.P. 1996?
d How the Pilot tubes / samples are numbered? YES/NO/NA As per Regn. No. of
Donor
e Whether pilot tube is attached in a tamper proof YES/NO/NA
 manner to the unit?
f Who is responsible for filing of pilot samples? YES/NO/NA Phlebotomist
g Whether pilot samples are filled immediately after YES/NO/NA
the blood is collected or at the time the final
product is prepared
h Whether expiry is assigned as per norms? YES/NO/NA
(Specify the period)
2. PLATELETS CONCENTRATES COMMENTS
a Whether SOP is available for preparation of YES/NO/NA
Platelet Concentrates?
SPECIFY: Source Material
Method
RCF
SPEED
TIME
b Whether the whole blood / source material is YES/NO/NA
stored at 20’ to 24’ C after collection, before
processing to platelet concentrates?

c Whether Platelet concentrates are separated within 6 YES/NO/NA

hours after the time of collection of whole blood / source
material?
d Whether Platelet concentrates are tested: YES/NO/NA
Platelet count (Note the count)
ph (not less than 6)
measurement of Plasma volume sterility (1% of total
platelets prepared shall be tested for sterility
Functional viability
(swirling movement)
e Whether compatibility test prepared on every unit before YES/NO/NA
issue?
f Whether platelet yield is calculated for each unit (1% of YES/NO/NA
total platelets prepared shall be tested of each 75% of
units shall confirm to standards?)

3. GRANULOCYTE CONCENTRATES (GC) COMMENTS

a Whether SOP is available for preparation of GC? YES/NO/NA
SPECIFY:
Source Material
Method
RCF
SPEED
TIME
b Whether group specific test / compatibility carried out on YES/NO/NA
each unit ? (if not, specify
wherever carried out)
c Whether HLA test carried out before issue? YES/NO/NA

d Whether GC yield is calculated ? YES/NO/NA

4. FRESH FROZEN PLASMA COMMENTS

a Whether SOP is available for preparation of FFP? YES/NO/NA
SPECIFY:
Source Material
Method
RCF
SPEED
TIME
b Whether deep freezers capable of maintaining YES/NO/NA
temperature between 75OC to 80OC & (-) 30OC to (-)
40O C are available?
c Whether the source material / human blood stored at YES/NO/NA
4OC till processed
 d Whether thawing facilities are provided (note the YES/NO/NA
thawing temperature)
e Lag time between collecting of blood and processing YES/NO/NA
of FFP (check records)
5. CRYOPRECIPITATE YES/NO/NA
a Whether SOP is available for preparation of FFP? YES/NO/NA
SPECIFY: Source Material
Method
RCF
SPEED
TIME
b Whether thawing facilities are available? (Note the YES/NO/NA
temperature)
c Whether anti – hemophilic factor activity is tested on YES/NO/NA
each container (NLT 80 units / bag), (1% of total Cryo
prepared shall be tested of each 75% conform to
specification)
6. APHERESIS PROCEDURE
a Whether cell separator facility is provided? YES/NO/NA
b Whether donor is certified fit for apheresis YES/NO/NA
(check the record)
c Lag time allowed between successive YES/NO/NA
apheresis on a single donor (Not the
lag time)
d Whether protein estimation of donor carried out YES/NO/NA
if serial apheresis are to be conducted
e Whether inquiries about aspirin intake made YES/NO/NA
before platelet apheresis
f Whether RBCs are re – transfused during YES/NO/NA
platelet apheresis or leucopheresis.
If not, what precautions are taken?
g Whether the following tests are carried out before apheresis procedures?
COMMENTS
NAME OF THE TEST ACCEPTANCE CRITERIA
i. Haemoglobin / Haematocrit
ii. Platelet Count
iii. WBC count
iv. Differential Count
v. Serum Protein
l How much quantity of Plasma is to be collected (Plasma apheresis)

DURATION LIMIT COMMENTS

i. SINGLE SITTING Not Exceeding 500 m/ / 1 sitting
ii. PER MONTH Not Exceeding 1000 m/ / 1 month
EEEE STORAGE OF BLOOD COMPONENTS
SL NO BLOOD COMPONENT TEMPERATURE DURATION / EXPIRY
PERIOD
1. FRESH FROZEN PLASMA
2. CRYOPRECIPITATE
3. PLATELET CONCENTRATES
4. RED CELL CONCENTRATES
5. GRANULOCYTESCONCENTRATES

FFFF RECORDS & LABELS YES / NO / NA COMMENTS

1. Whether details of quantity supplied, YES / NO / NA
compatibility report, details of receipts, &
signature of issuing person mentioned in the
component period
2. Whether master record for component & issue YES / NO / NA
register is mentioned as per norms (GSR 245
E dated: 05 – 04 – 1999)
3. Whether labels for components are prepared YES / NO / NA
as per norms (GSR E
 DATED 05 – 04 – 1999)
4. Whether all details on labels are filed by the YES / NO / NA
responsible person on the final
container
5. Comments on the trace ability system of YES / NO / NA
record
GGGG Total number of components prepared with their final disposition
YEAR ITEMS FINAL DISPOSITION TOTAL
PROCESSING
Used in Hospital Issued Outside Discarded

OBSERVATIONS, IRREGULARITIES & RECOMMENDATIONS

SIGNATURE & DESIGNATIONS OF INSPECTING PERSONS