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Hospital mortality
Actual expenditure on
pattern
Indicators Parameters
7 Resource utilization
Infrastructure
Equipment
ICU:
8 Customer external
Internal Customer
addressed.
2. Clinical monitoring includes those aspects of laboratory services selected b y the leaders
(Laboratory-machines and test quality control)
3. Clinical monitoring includes those aspects of radiology and diagnostic imaging services
selected by the leaders (Radiology-TLD check) (Radiology-Quality Control Reporting)
4. Clinical monitoring includes those aspects of surgical care selected by the leaders
(Returned to OR/DR within 24 hours after procedure)
5. Clinical monitoring includes those aspects of antibiotics and other medication use selected
by the leaders (a)Percentage of restricted antibiotic consumption) (b)Adverse drug reaction
(ADR)
6. Clinical monitoring includes of medication and near misses (Medication Error (ME)
7. Clinical monitoring includes the those aspects of anesthesia and sedation use selected by
the leaders (Moderate Sedation/Analgesia documentation in Anesthesia)
8. Clinical monitoring includes the those aspects of the use of blood and blood products
selected by the leaders
(a)Percent of compliance in reporting of blood and blood product transfusion reaction
(b)Percent of compliance with Blood and blood product Transfusion (cross
matched/transfusion Ratio)
(c)Percent of compliance with duration time Blood is transfused after release from blood
Bank)
9. Clinical monitoring includes the those aspects of availability, content and use of the
patient’s record selected by the leaders
(a) Percent of compliance with contents element of Medical record.
(b) Percent of compliance with MR availability in OPD
10. Clinical monitoring includes the those aspects of infection control, surveillance and
reporting selected by the leaders
(a) Nosocomial Infection rate related to patients stay in the ICU’s
(b) Nosocomial Infection rate related to devices
(c)Percent compliance with hand hygiene Policy
11. Clinical monitoring includes those aspects of clinical research selected by the leaders
(Not applicable)
14. Managerial monitoring includes those aspects of risk management selected by the
leaders (Percent of action taken and completion of OVR)
15. Managerial monitoring includes those aspects of utilization management selected by the
leaders
(a)Percent of compliance with Average Length of Stay of most common diagnosis and
procedures)
(b)Percent of average length of stay by department/year
16. Managerial monitoring includes those aspects of patient and family expectation and
satisfaction selected by the leaders (Percent of complaints with patient satisfaction)
17. Managerial monitoring includes those aspects of staff expectation and satisfaction
selected by the leaders (Percent of staff expectation and Satisfaction)
18. Managerial monitoring includes those aspects of patients demographics and clinical
diagnoses selected by the leaders (Demographic Data)
(Percent patient seen in the OPD by specialty)
19. Managerial monitoring includes those aspects of financial management selected by the
leaders (Percent of cost for commissioned bed)
20. Managerial monitoring includes those aspects of the prevention and control of events
that jeopardize the safety of the patients, families and staff selected by the leaders,
including IPSG
(a)Percent of patient’s falls in the inpatients floors
(b)Percent of staff injury/Exposure to BBF)
What is the difference between accreditation, certification and licensure? Give an
example of each.
The aim of clinical audit is continuous improvement of the quality of care through systematic and critical review of
current practice against explicit criteria and the implementation of change if necessary. The audit is a regular
multidisciplinary activity by which all participants of care including doctors, nurses and other health professionals
carry out a systematic review of their own practice. Data collected during the process of audit should be handled with
care, and individual data concerning care-givers, patients or health professionals must be treated confidentially.
Clinical audit needs realistic timeframe and necessary resources as well as tolerant culture of learning organisations.
Furthermore the success of clinical audit depends on the commitment and support of the management of the
organisations. Clinical audit could relatively easily be embodied into the current practice of peer-review processes
and other quality improvement initiatives in Hungary. Widespread and systemic application of clinical audit may
improve the quality of patient care and maintain the trust of the population. However, clinical audit should be effective
and cost-effective. The recently published methodological guideline by the Ministry intends to promote good practice
in clinical audit.
it helps to improve the quality of the service being offered to users. Without some form of
clinical audit, it is very difficult to know whether you are practising effectively and even more
difficult to demonstrate this to others. The benefits of clinical audit are that it:
• identifies and promotes good practice and can lead to improvements in service delivery
• can provide the information you need to show others that your service is effective (and
• can improve working relationships, communication and liaison between staff, staff and
ASSESSOR GUIDE
FOR
BLOOD BANKS/ BLOOD CENTRES Assessor Guide for Blood Banks/ Blood Centres – NABH-AG (BB)
Contents
Contents 2
1. Introduction 3
4. Pre-Assessment 5
5. On-Site Assessment 6
6. Assessor Checklist 14
7. Declaration of Impartiality, Confidentiality and Integrity (NABH I&C_BB 01) 81 Assessor Guide for
Blood Banks/ Blood Centres – NABH-AG (BB)
1 INTRODUCTION
transfusion and distribution of blood and blood products. The National Accreditation Board for
Hospitals and Healthcare Providers (NABH) provides third-party accreditation to Blood banks/
The assessment is carried out by a team of NABH empanelled Assessors, lead by a Principal
Assessor. The assessment is carried out systematically for comprehensive review of the
quality and operational systems within the facility. The objective evidence so collected forms
the basis:
Committee
• for formulating the advice to assist the blood bank in its development.
This guide has been prepared based on the general practices followed by international bodies
and the experience of experts of the country. This document accordingly aims to:
a. Provide the guidance to the Assessors during the assessment of blood banks/ blood
centres.
The role of NABH Assessment team is to conduct on-site assessment of applicant blood
The objective of the on-site assessment is to obtain evidence on compliance with respect to
Since blood bank accreditation requires compliance with NABH Standards the assessment
team should consider conformances against these standards in the assessment. Thus, the
members of the assessment team would be required to exercise their scientific judgmental
skill and form their opinion regarding extent of conformance with respect to accreditation
criteria.
Notwithstanding the strength of the NABH system, the success of the accreditation scheme
depends on the assessment team who performs on-site assessment and, thus, play a vital
role in determining the credibility and value of the accreditation. Assessor Guide for Blood Banks/ Blood
Centres – NABH-AG (BB)
The assessment team consists primarily of Principal Assessor and Assessor. However, in
some cases a technical expert may join the team to support on specific area.
Team members are required to maintain the confidentiality on the matters/ subjects related to
Before the start of assessment, Principal Assessor shall prepare an Assessment schedule in
BAF 1 which should include the departments/ sections/ areas/ activities to be assessed and
assignment to various Assessors based on their expertise. The Observer (Potential Assessor)
The Principal Assessor must review the blood bank/ blood centre’s documented Quality
System to verify compliance with the requirements of NABH Standards for Blood Bank/ Blood
Centre and Transfusion Services. He should assess that the documented Quality System is
indeed implemented & effective, as described and record observations in BAF 2. He should
also complete Checklist and record conclusion/ comments related to the requirements of
respective clause number. All Non-Conformity (ies) must be identified and reported,
As a leader of the Assessment team, he would collect the reports and documents from all
Technical Assessors including his own report and compile it. Any Non-Conformity, which can
case of total system failure and gross negligence in technical aspects is noticed, the Principal
Assessor will at the earliest inform NABH and elaborately bring it out in the Assessment
Assessment and record the recommendations in BAF 5. The Principal Assessor must sign all
He must get an endorsement from the blood bank on BAF 6 and hand over a photocopy of the
forms BAF 3, 4, and 5 to the blood bank to enable them to take corrective actions.
The Principal Assessor is also required to monitor the performance of Assessor(s) and the
Observer. He shall recommend whether the Observer is capable to perform the role of a
Assessor in his next visit. His comments/ rating for each Assessor shall be enclosed with the
report.
Role of Assessor
The Assessor should clearly understand the areas/ activities to be assessed by him. He must
review the Blood bank’s documented system to verify compliance with the requirements of
NABH standards. He should assess to verify that the documented SOPs, test methods and
records are indeed implemented & effective, as described and record observations in BAF 2.
He should assist Principal Assessor in completing the Checklist. The report should be handed
over to the Principal Assessor along with expenditure claim form. Assessor Guide for Blood Banks/
Blood Centres – NABH-AG (BB)
The role of Technical Expert is same as of an Assessor. He will provide technical assistance
to the team and he will seek guidance of Principal Assessor in filling the relevant forms.
Role of Observer
The Observer (Potential Assessor) will be assigned to accompany the Principal Assessor as
per the schedule provided to him. The Principal Assessor shall guide him. He is not involved
in assessment directly but supports the assessment as assigned by the Principal Assessor.
NABH appoints Principal Assessor from the pool of empanelled assessors from assessor
database. Scope of the blood bank is kept in mind which selecting the Principal Assessor. The
name of Principal Assessor and assessor(s) and the names of their organisations from which
they belong are intimated to the organization for seeking their consent.
Principal Assessor appointed shall be responsible for adequacy of the quality manual and the
application form. The Principal Assessor shall inform NABH regarding inadequacies in the
quality manual, if any. The blood bank shall address to the inadequacies pointed out by the
Principal Assessor in their quality manual and implement the corrective actions in their
management system.
4. PRE-ASSESSMENT
bank. NABH shall organize the pre-assessment of the blood bank in case there are no
inadequacies in the quality manual or when the blood bank has taken satisfactory the
corrective action. The blood bank shall ensure their preparedness by carrying out internal
Objective of Pre-assessment:
• to review the scope of accreditation and ascertain the requirement of the number of
document ‘Pre-Assessment Guidelines & Forms’. Copy of the report is handed over to the
blood bank after the assessment and original sent to NABH Secretariat. Assessor Guide for Blood Banks/
Blood Centres – NABH-AG (BB)
5. ON-SITE ASSESSMENT
A similar methodology as used in the Pre-Assessment is followed in comprising the team for
final assessment of the blood bank/ blood centre. The number of assessors depends on the
The assessor(s) and the names of their organizations from which they belong are intimated to
the blood bank for seeking their consent. NABH also assures that the team does not have any
competitive position with the applicant organization. NABH also ensures that assessors do not
have any direct/ in-direct relationship with the organization or they/ or their organization.
Consent is obtained for the date(s) of the assessment of the organization from the Principal
Assessor and other assessors accompanying for the assessment. A written communication is
- Quality Manual
- Pre-Assessment report
Assessment Team shall meet and plan assessment programme. This shall include the
distribution of work amongst the Assessors. The format of the assessment schedule to be
representatives where they get acquainted with the blood bank, departments/ sections
(b) The Principal Assessors shall explain in his opening remarks that the object of the
assessment is to assess the work of the blood bank according to the NABH standards.
He shall make it clear as to what is expected from the blood bank during the
assessment.
(c) The Principal Assessor shall present the assessment schedule (BAF 1) to blood bank
(d) The Principal Assessor shall inform the blood bank that the assessment team shall not
report is being compiled. Assessor Guide for Blood Banks/ Blood Centres – NABH-AG (BB)
5.2 Assessment
- The Assessment Team shall proceed to various sections/ department of the blood bank as
planned earlier.
- The Assessor(s) should verify the effectiveness of Quality System and related documents
using audit techniques and shall raise non-conformities. The Principal Assessor shall use
- The Assessor(s) should also thoroughly examine the technical competence of the blood
of the blood bank is being carried out in accordance with the ‘NABH Standards on Blood
Banks/ Blood Centres and Transfusion Services’. Assessor shall record detailed nonconformities as they
occur on BAF 3. Each non-conformity shall be countersigned by the
- During assessment, Assessors would discuss with the management representative of the
blood bank whether the blood bank is participating in the External Quality Assurance
Programme. They would look for their performance and action taken if the performance
was unsatisfactory.
- The Checklist provided should be verified and completed during the course of the
assessment of the blood bank. Checklist are like aid memoir to Assessors so that all
aspect of the blood bank Quality System and technical criteria are taken care of.
The Assessment Report should consist of various documents in the order as indicated in
BAF 5. Each form or checklist should be carefully filled in. The pages should be serially
numbered.
Principal Assessor shall compile the observations from the assessors (BAF 2) and summary
The Principal Assessor shall give the summary of the assessment in his final report
(BAF 5). The reports shall be signed by the authorized signatory of the blood bank.
In addition to the above, Principal Assessor in consultation with the team members shall fill up
the score sheet and send it to NABH along with report. This remains a confidential document
and copy should not be given to the blood bank. Assessor Guide for Blood Banks/ Blood Centres –
NABH-AG (BB)
Issue No. 1 Issue Date: 05/ 08 Page 8 of 81
Assessment Standard: NABH standards on Blood Banks/ Blood Centres and Transfusion
Services
Date/Time
/ Time
Morning: AM to PM
Afternoon: PM to PM
Opening Meeting:
Closing Meeting:
Day 1:
Day 2:
Day 3:
assessors/ technical expert in the following format and obtained their signature.
Principal Assessor
Assessor 1
Assessor 2
Assessor --
Observer/Expert
Signature of Principal AssessorAssessor Guide for Blood Banks/ Blood Centres – NABH-AG (BB)
Auditee:
Signature & Name of AssessorAssessor Guide for Blood Banks/ Blood Centres – NABH-AG (BB)
Representative
Signature & Name of AssessorAssessor Guide for Blood Banks/ Blood Centres – NABH-AG (BB)
Page 1 of 2
NABH Std.
Clause No.
during Assessment
MAJOR MINOR
1.2 Responsibility
3 Personnel
3.2 Qualification
Manager
3.5 Training
3.6 Competence
4 Equipment
equipment
5.3 Evaluation of suppliers Assessor Guide for Blood Banks/ Blood Centres – NABH-AG (BB)
Page 2 of 2
6 Process Control
6.5 Labelling
detected
7.2 Procedures for release of non-conforming blood
component
8 Performance Improvement
9 Document Control
documents
10 Record
review
The non-conformities raised during the assessment are as a result of limited sampling and therefore it
shall
not be assumed that other non-conformities do not exist.
Sig. & Name of Authorised Signatory of Blood bank Sig. & Name of Principal AssessorAssessor Guide for
Blood Banks/ Blood Centres – NABH-AG (BB)
Assessor 2: Assessor 3:
Other/TE Observer:
Purpose:
ASSESSMENT SUMMARY:
Signature of Principal Assessor & DateAssessor Guide for Blood Banks/ Blood Centres – NABH-AG (BB)
ASSESSOR CHECKLIST
NABH-Checklist
The following pages present a checklist of the criteria from Standards for Blood Bank/ Blood Centre
and Transfusion Services, which is the basis for the NABH requirements for accreditation of Blood
Bank/ Blood Centre. The Blood Bank/ Blood Centre’s policies and procedures must meet full
requirements of NABH requirements.
The Principal Assessor must complete this checklist, put initials on each page. The following symbols
++ = COMPLIANCE
A = MAJOR NON-CONFORMITY
B = MINOR NON-CONFORMITY
NA = NOT APPLICABLE
The Principal Assessor must review the blood bank’s documented system to verify conformity with
the requirements of NABH standards, assess to verify that the documented quality system is indeed
implemented as described, record conclusion/ comments related to any requirements on the space
provided or use the bottom of the page or use separate sheet(s). All non-conformities must be
identified and reported separately on each sheet of BAF-3. This checklist be submitted as a part of
CITY/ TOWN
PRINCIPAL ASSESSOR’S
NAME
SIGNATURE
Major Non-Conformity: absence of which may result in total breakdown (commission, failure, not
system or reduce its ability to assure controlled processes or products Assessor Guide for Blood Banks/
Blood Centres – NABH-AG (BB)
ASSESSOR CHECKLIST
(NABH Standards for Blood Bank/ Blood Centre and Transfusion Services)
Implementation
Remarks
- is legally identifiable.
1.2 Responsibility
standards and local regulations. Assessor Guide for Blood Banks/ Blood Centres – NABH-AG (BB)
Implementation
Remarks
management system
1.4.4 Personnel shall be instructed to familiarize
referenced documents.
process and procedures. Assessor Guide for Blood Banks/ Blood Centres – NABH-AG (BB)
Implementation
Remarks
2 ACCOMMODATION AND ENVIRONMENT
adequate facilities
- refreshment-cum-rest room
- store-cum-record room.
2.1.3 Processing of blood component from whole blood by a blood bank/ blood centre
depending upon the quantum of work load. Assessor Guide for Blood Banks/ Blood Centres – NABH-AG
(BB)
Implementation
Remarks
leucapheresis
documented regarding:
- personnel working
- equipment used
- facilities available
available space
donors
Implementation
Remarks
for:
- good housekeeping
supply.
radiation safety
quality of results
within the centre for efficient transfer of message.Assessor Guide for Blood Banks/ Blood Centres –
NABH-AG (BB)
Implementation
Remarks
3 PERSONNEL
3.2 Qualification
- Technician (s)
- Registered Nurse(s)
- Technical Supervisor
position.
experience.
Implementation
Remarks
3.5 Training
centre
adverse incidents.
3.6 Competence
- certificate/ license
possible
- job description
Implementation
Remarks
achievement
- competency evaluation
- immunization status
to be kept confidential and in safe place. Assessor Guide for Blood Banks/ Blood Centres – NABH-AG
(BB)
Implementation
Remarks
4 EQUIPMENT
procedures for:
- calibration
- maintenance
- monitoring
examinations concerned.
4.3 Use of equipment
include:
- Identification
number
service
Implementation
Remarks
reconditioned)
the future
- calibration of equipments
- function of instruments
- reagents
- analytical system
Implementation
Remarks
at 22 ± 2
C.
ensure that:
validated
integrity of data
repaired and then calibrated before put in use. Assessor Guide for Blood Banks/ Blood Centres – NABH-
AG (BB)
Implementation
Remarks
regulations
- method for inspection, acceptance/ rejection
quality of services
blood components
be done.
Implementation
Remarks
- external services
- supplies
- purchased product
these evaluations and list of those approved. Assessor Guide for Blood Banks/ Blood Centres – NABH-AG
(BB)
Implementation
Remarks
6 PROCESS CONTROL
were performed:
- collection
- processing
- compatibility testing
derivatives
6.1.1 Traceability of blood unit and sample from blood collection to issue blood
- laboratory sample
Implementation
Remarks
shall be followed.
- documentation
understandable language.
Implementation
Remarks
- by Director/ In-charge
may include:
- collection of blood from voluntary, nonremunerated, low risk, safe and healthy
donors
- encouraging and retaining adequate number
of repeat donors
blood
Implementation
Remarks
safety
period
6.2.1.3 Donor registration, consent and selection
a) Donor registration
activities:
staff
MBBS
b) Consent
following activities:
safety of recipients
procedure is explained
- giving the donor opportunity to ask questions
Implementation
Remarks
recipients.
d) Donation interval
from a donor.
Apheresis shall be done only after three months
months.
shall be followed.
Implementation
Remarks
continuous
product.
- sterile
- pyrogen-free and disposable with a closed
national authority.
C for red
cells).
Implementation
Remarks
d) Anticoagulant solutions
- of appropriate strength
- Addition of appropriate additive solution to
storage
e) Volume
transfusion.
Implementation
Remarks
authorized by SBTC.
available
blood units
- inspect the donation site prior to the day of
Large Camps
state authority.
- labeling required
- pretransfusion testing
Implementation
Remarks
management.
- Demographic details
- Identification number
examination)
- Deferral records
following:
- date of collection
Implementation
Remarks
- particulars of donor
- identification number
details:
- management details
in future
following:
- identification number
- disposition record
details:
the following:
- reaction results
reagents in use
- reagent red cells in use
Implementation
Remarks
- batch number
testing
competent individual
- apheresis procedures
- blood discarded
6.2.1.11 Therapeutic plasmapheresis and cytapheresis
- diagnosis
- therapeutic procedures
- haemapheresis method
- time taken
- medication administered
taken.
Implementation
Remarks
Therapeutic phlebotomy
compatibility tests.
destination.
Implementation
Remarks
recipients.
6.2.2.3 Transportation
- storing
- component preparation
transportation.
6.3.1 Sterility
6.3.2 Seal
(closed system).
stored between 4
C±2
C±2
o
hours.
Implementation
Remarks
within 6 hours.
preparation of:
date of blood.
centrifuging at 4
C±2
o
recommended.
Implementation
Remarks
when
concentrate:
C to –196
C in the
years.
by centrifugation at 22
C+ 2
o
C using either
22
C+ 2
Implementation
Remarks
10
leucocytes and
shall be kept at 22
C±2
C for a maximum
period of 24 hours.
d) Plasma:
Single donor plasma
C or
collection.
lower.
C±2
o
C.
Plasma
30
Implementation
Remarks
C and then
C or lower and
when needed thawed at 4
C in circulating
water bath or in 4
refrigerator.
kept at –30
f) Donor Apheresis:
medical officer.
storage.
areas shall be controlled. Assessor Guide for Blood Banks/ Blood Centres – NABH-AG (BB)
Implementation
Remarks
specific laboratories.
prevention.
6.4.2 Quarantine
appropriately labelled.
Implementation
Remarks
C±2
C in
prepared.
C±
C.
C and - 196
C.
shall be stored at 4
C±2
o
C and shall be
shall be stored at 4
C±2
be within 24 hours.
Implementation
Remarks
at 22
C±2
o
C with continuous gentle flat bed
use.
22
C±2
phlebotomy.
Plasma
30
transfusion.
- Fresh-frozen plasma and cryoprecipitate:
12 months.
C, it may be
years.
shall be stored at - 30
date of collection.
Remarks
6.5 Labelling
requirements.
- traceability of product
and shall be clean and readable. Any handwritten information shall be legible and in
apheresis
groups
- Storage temperature
Implementation
Remarks
deterioration
C±2
C)
blood/blood component
transfuse blood
- Storage temperature
- Expiry date/time
- If the plasma is intended for use of
Implementation
Remarks
of the following:
Malaria
number
needed/ required
e) routine/ emergency
f) diagnosis
count
recipient
Implementation
Remarks
number
b) Name of hospital
Implementation
Remarks
positive cells
C by
negative).
if possible.
attached segment.
Crossmatch
antiglobulin test.
Implementation
Remarks
warning to clinicians.
mandatory.
- age
- sex
- identification number
the blood.
Implementation
Remarks
information:
- hospital name
- identification number
collecting/intermediary facility
broken.
years.
Implementation
Remarks
immediately.
6.7.4.4 Selection of blood and components for transfusion
observation.
Single donor plasma and fresh frozen plasma
Implementation
Remarks
Platelets concentrate
Granulocyte concentrate
blood.
used after active bleeding is controlled for crossmatch at the time of subsequent transfusion of
6.7.4.6 Neonates
required.
unexpected antibody(ies).
compatibility testing.
haemoglobin S if possible.
Implementation
Remarks
transfusion.
exchange transfusion.
• Compatibility record
investigation
blood/component issued
components
matters through meeting. Assessor Guide for Blood Banks/ Blood Centres – NABH-AG (BB)
Remarks
patient/recipient:
- alternatives available
transfusion.
committee.
Implementation
Remarks
done:
- massive transfusion
alarm system.
components.
ringer’s solution.
equipment.
compatible.
Implementation
Remarks
is thawed at temperature of 37
C.
stored at 1 - 6
C.
Cryoprecipitate
of 37
C.
Cryopoor plasma
37
at 1- 6
C.
Implementation
Remarks
patient/recipient.
Irradiation
before transfusion
it should be 15 Gy.
annually.
accordingly.
irradiation.
Remarks
leukocytes in the
blood bag.
as:
and initials
sample
Assessor Guide for Blood Banks/ Blood Centres – NABH-AG (BB)
Implementation
Remarks
metabolites
immediately.
Implementation
Remarks
sample
transfusion reactions.
patient/recipient records.
interpretation.
standard) Assessor Guide for Blood Banks/ Blood Centres – NABH-AG (BB)
Remarks
Organisation.
- HLA typing
- compatibility testing
- sample identification
shall include:
on receipt
and discoloration
Implementation
Remarks
information
instructions
- no reagents to be used after date of expiry
manufacturer.
group.
confirm specificity.
C.
o
C, shall
controls.
Implementation
Remarks
incomplete antibodies.
standard method.
thawed.
the manufacturer.
Positive and negative control (kit control or inhouse) shall be run with every batch.
Implementation
Remarks
used.
instructions.
Positive and negative controls (kit control and inhouse) must be included with every batch.
corrective action.
Implementation
Remarks
6.13 Bio-medical waste disposal and laboratory safety in blood bank/ blood centre
6.13.1 Protection of blood bank/ blood centre personnel against laboratory infection
may include:
centre laboratory
of the lab
the lab
in the lab
of materials
Implementation
Remarks
day
disposal or reuse
incident report
containers
discarded in puncture proof container or a nonchlorinated plastic. These shall then be sent for
C for 1 hour.
put in 2% glutaraldehyde).
Implementation
Remarks
Disposal by Sterilisation
C and 15 p.s.i
month.
Implementation
Remarks
down procedure.
7.1.2 After the occurrence of deviated function, the
down for:
action
and procedure for release/ discard of nonconforming blood component and may include:
same
eliminate the root cause of non-conformity. Assessor Guide for Blood Banks/ Blood Centres – NABH-AG
(BB)
Implementation
Remarks
8 PERFORMANCE IMPROVEMENT
1. addressing complaints
2. corrective action
3. preventive action
of the problem.
Implementation
Remarks
such non-conformities
are effective.
Implementation
Remarks
9 DOCUMENT CONTROL
2. document requirements
examination procedures.
prior to issue.
9.1.3 Blood bank shall maintain a master list of
personnel.
from all points of use. Assessor Guide for Blood Banks/ Blood Centres – NABH-AG (BB)
Implementation
Remarks
practicable.
standards.
Electronic Records
critical data
Implementation
Remarks
be ensured
usable
of data entry
Implementation
Remarks
10 RECORDS
retention policies.
defined period.
unauthorized access.
3. record retaining period: stated policy shall be
annexure E
Implementation
Remarks
agreed time.
year.
Implementation
Remarks
personnel
audit
preventive action.
NABH I&C_BB 01
(to be filled in by each Assessor and enclosed with the Assessment report)
Name Assessor ID :
Designation
Organisation
Address
Health care
organisation Assessed
Date of visit(s)
Verification
I ______________________________________________________________, hereby declare that
i. I have not offered any consultancy, guidance, supervision or other services to the blood bank, in
any way.
ii. I am/ am not* an ex-employee of the health care organisation and am/ am not* related to any
iii. I got an opportunity to go through various documents of the above hospital and other related
information that might have been given by NABH. I undertake to maintain strict confidentiality of
the information acquired in course of discharge of my responsibility and shall not disclose to any
Date:
Place : Signature