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Dissertation

Study of the Quality Assurance Programme, Identify the Gaps and recommend measures for improvement in Blood Transfusion Services

Submitted to the Faculty of

Department of Hospital Administration


All India Institute of Medical Sciences, New Delhi

In partial fulfillment of the requirements for the degree of

Master in Hospital Administration

Dr Shakti Kumar Gupta Head, Department of Hospital Administration AIIMS, New Delhi

Dr Rama Bhasin CMO i/c Blood Bank, CN Center AIIMS, New Delhi

Dr IB Singh Associate Professor Dept of Hospital Administration AIIMS, New Delhi

Submitted By Lt Col (Dr) Rakesh Verma Resident Administrator Department of Hospital Administration AIIMS, New Delhi

TABLE OF CONTENTS Introduction ....................................................................................... 3 Aim ................................................................................................... 6 Methodology ...................................................................................... 7 Observations And Discussion .............................................................. 8 Conclusion ...................................................................................... 14 References....................................................................................... 15

INTRODUCTION
Transfusion of blood and blood components is an established standard way of treating patients who are deficient in one or more blood constituents and is therefore an essential part of health care. A blood transfusion service is a complex organization requiring careful design and management. Essential functions of a blood transfusion service are donor recruitment, blood collection, testing of donor blood, component preparation and supply of these components to the patients. Functions of a Blood Transfusion Service1

The basic functions of a blood transfusion centre may be listed as follows: 1) Recruitment and retention of voluntary and replacement blood donors. 2) Collection, processing, storage and transportation of blood and its components. 3) Laboratory procedures a) Blood group serology grouping & cross matching b) Screening for Transfusion transmitted infections 4) Participation in the clinical use of blood and blood components. 5) Teaching and training of personnel 6) Research and development Quality Assurance in Blood Transfusion Service

The primary goal of quality in the context of blood bank is 'transfusion of safe unit of blood.' The objective is to ensure availability of a sufficient supply of blood, blood components of high quality with maximum efficacy and minimum risk to both donors and patients.

Need for Quality

A failure in the quality of blood collected or screening of donated blood unit can be very serious and may result in fatal consequences. If appropriate quality systems are designed, implemented and monitored, the issue of an improperly tested unit can be avoided.

Besides laboratory testing, a failure in the quality system can lead to numerous situations which may be potentially dangerous to the patient, donors and the staff. Some of these are: 1. Failure to identify the patient correctly. 2. Wrong sample labeling. 3. Mix-up of results amongst different patients. 4. Failure to detect presence of an abnormality (clinically significant antibodies) in the patient's sample. 5. Issue of unscreened blood due to faulty laboratory procedures. 6. Issues concerning the tested blood units like: a. Use of screening kits of reduces sensitivity and specificity. b. False negatives c. Window periods in which donor would not test positive even though he may be carrying infection. Therefore, it is very important to recognize the need for quality and to introduce Quality Manufacturing Practices (QMP), Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP) etc. Quality Assurance Quality assurance deals with the maintenance of a system to ensure that the performance in the blood bank is of the required quality. It means that a management system exists to look into provision of a safe
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unit of blood and, if any potential errors / errors are prevented / identified and corrected. Quality System & Total Quality Management (TQM)

In a blood transfusion service, the quality system deals with all aspects to ensure that the product or the tested and 'safe unit of blood' is as safe as possible. It includes the implementation, maintenance and monitoring of the quality assurance system. Internal quality Assurance (IQA)

Internal quality assurance is meant to allow laboratory technicians to check their performance by themselves and help them to monitor the reliability of their technique. In other words, it deals with the measures taken by a local laboratory to maintain laboratory standards.

IQA includes procedures designed for continuous evaluation of the work of the laboratory concerned and it aims at achieving high level of safety and efficiency. External quality assurance (EQA)

External quality assurance involves a central reference facility which monitors the standards of for blood banks laboratories. EQA is a system whereby a set of reagents and techniques are assessed by an external source and the results of blood banks are compared with those of an approved reference facility.

AIM
The aim of this study is to study the Quality Assurance Programme, Identify the Gaps and recommend measures for improvement in Blood Transfusion Services at the Blood Bank at CN Center, All India Institute of Medical Sciences, New Delhi.

METHODOLOGY
Duration of the Study The study was carried out during September-November 2008. Study setting The study was carried out at the Blood Bank, Cardiothoracic & Neurosciences Center, All India Institute of Medical Sciences, New Delhi. Study design The study is an observational study of the Blood Bank, CN Center, AIIMS. It is done in two stages as given in the succeeding paragraphs. In the first stage available relevant literature was reviewed. The processes and work flow at the blood bank were studied in detail. The draft Standards for Blood Bank / Blood Center and Transfusion Services2 as prepared by National Board for Hospitals and Healthcare Providers (NABH) were studied in detail. Based upon the NABH standards for the blood bank a check list has been prepared. This check list has been used to obtain information about conformance with the standards in he Blood Bank, CN Center for the purpose of this study. In the second stage, the information obtained about the quality assurance system at the blood bank is compiled and analysed to identify the gaps and to recommend the appropriate measures.

OBSERVATIONS AND DISCUSSION


The Blood Bank of Cardio-thoracic Center (CN Center), All India Institute of Medical Sciences, New Delhi (Referred as Blood Bank hereafter) caters for the requirement of blood and blood components of CN Center. The center is an amalgamation of two centers viz. Cardiothoracic and Neurosciences that function independent of each other yet share the common services and central facilities of CN Center. The CN Center consists of the following departments: -

Cardiothoracic Center Cardiology Cardiac Anaesthesiology Cardiac Pathology Cardiac Radiology Cardiothoracic & Vascular Surgery Cardiac Biochemistry ORBO & Stem Cell Facility Nuclear Medicine

Neurosciences Center Neurology Neuro-Surgery Neuro Anaesthesiology Neuro Biochemistry Neuro Pathology Neuro Psychology Neuro Radiology

Out of these departments only the clinical departments use the services of Blood Bank. The usage is predominantly by the CTVS and neurosurgery departments of the two centers. The quality assurance programme at the Blood Bank has been examined by using the checklist that was prepared for the purpose. The parameters of the checklist were evaluated in respect of the blood bank using detailed requirements given in the draft edition of the NABH standards for Blood Banks. Three level grades were used viz. Nonconformance, Partial Conformance and Full conformance. The full checklist along with the scoring is enclosed at Appendix A. The summary

of the information about the conformance with the standards is given at Table No. 1.
Table No. 1: Summary of Conformance information Non Conformance Partial Conformance 3 7 10 Checklist Full Conformance 5 4 3 7 3 63 3 4 2 3 4 100 9 Total No of Standards 5 4 9 8 3 70 3 5 3 3 4 117

1. Organization & Management 2. Accommodation & Environment 3. Staff 4. Equipment 5. External Services: supplies & Reagents 6. Process Control 7. Identification of Deviations & Adverse Events with control of non-conformance 8. Performance Improvement 9. Document Control 10. Record 11. Internal Audit & Management Review Total

3 1 1 1 1 7

* - HLA Testing not being done in the blood bank.

The standards where the non-conformance has been observed are given in Table No. 2 below: Table No. 2: Non-conformed Standards 1. Staff a. Job descriptions & responsibilities b. Responsibilities of Director, i/c, tech manager and quality manager c. Personnel health 2. Equipment a. Computer system 3. Process Control a. Proficiency testing programmes 4. Performance Improvement a. Addressing complaints 5. Document Control a. Maintenance of documents in computer software The standards where the partial-conformance has been observed are given in Table No. 3 below: Table No. 2: Partially-conformed Standards 1. Staff a. Training b. Competence c. Personnel records 2. Process control a. Pre-donation counseling b. Instruction for transfusion c. Tests for transfusion transmitted infections d. Administration (of blood / component) e. Transfusion practices guidelines f. Protection of personnel against lab infection g. Safety in lab
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In this study of the quality assurance programme at Blood Bank, it is observed that the non-conformance and the partial conformance constitute gaps that need to be addressed. Measures for addressing the gaps

The following measures are recommended for addressing the gaps as observed in this study: 1. Staff a. Job description and responsibilities of various categories of staff should be delineated and recorded. This can be done by carrying out the detailed job analysis of all categories of staff to remove any ill-defined areas of responsibility to clearly indicate the accountability of tasks performed.

b. Even though almost entire staff is permanent and has years of experience, the requirement of periodic training especially in quality systems need to be instituted.

c. Competence testing of staff must also become integral part of every training module. d. At present there is no mechanism of carrying out period medical examination of staff working in the blood bank. Only vaccination has been carried out against preventable diseases. Periodic medical examination would also help the staff from the occupational health perspective. For this purpose annual physical examination of the staff should be carried out. They should also be tested for hepatitis B, hepatitis C, HIV and level of hemoglobin. A copy of the record
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of this annual examination should be kept in the personal file of the individual staff member.

2.

Process control

a. Pre-donation counseling need to be included in the donor selection protocol.

b. Instruction for transfusion Even though detailed instruction exist on every bag of blood, the same is not indicated on the satellite bags. All bags must have instructions for transfusion. Two additional instructions as under are required to be included: i. Do not add any medication with the blood / blood component.

ii. Do not dispense without written prescription.

c. Tests for transfusion transmitted infections Tests for malaria


is to be included.

d. Transfusion practices guidelines Though transfusion practices guidelines exist, these need to be compiled and published for usage and reference by all concerned. e. Protection of personnel against lab infection Practice of wearing gloves at all timed in the lab needs to be enforced. f. Safety in lab Though various safety procedures are in place and are recorded in SOPs, these need to re-emphasize periodically and reinforced for compliance.

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3.

Equipment a. A computerized system needs to be installed so that the entire information recording of various processes can be carried out in an automated manner. This will also facilitate faster retrieval of information and allow for easy tracking of donor, blood and test records.

4.

Process Control

b. Proficiency testing programmes need to be initiated for all members of staff.

6.

Performance Improvement

a. A system of feedback, from all categories of personnel, donors and patients who interface with the blood bank, should be provided. Regular analysis and appraisal of feedback has the potential to become a potent improvement tool.

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CONCLUSION
A simple definition of quality is 'fitness for a purpose'. In blood transfusion service, the primary goal of quality assurance programme is 'transfusion of safe unit of blood / component.' The objective is to ensure availability of a sufficient supply of blood, blood components of high quality with maximum efficacy and minimum risk to donors, patients and personnel of blood bank.

A quality assurance program in blood bank is designed and implemented to ensure that processes are consistently performed in such a way as to yield blood and blood products of consistent quality. It is the sum of activities planned and performed to provide confidence that all systems and their elements that influence the quality of the blood and blood components are functioning as expected and can be relied upon. In this study the quality assurance programme at the Blood Bank, CN Center has been studied and certain measures as relevant to the blood bank for further augment the quality conformance have been detailed.

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REFERENCES
1. http://www.bloodindex.net/blood_bank_functions.php accessed on 24 April 2008

2.

National Board for Hospitals and Healthcare Providers, Draft Standards for Blood

Bank / Blood Center and Transfusion Services, Draft Edition.

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Appendix A CHECK LIST : QUALITY ASSURANCE PROGRAMME AT BLOOD BANK, CN CENTER, AIIMS

Checklist 1. Organization & Management a. b. c. d. e. 2. Legal entity Responsibility, Ethics in blood bank / blood center Quality systems Policies, processes & procedures

Non Partial Full Conformance Conformance Conformance


Accommodation & environment a. b. c. d. Space allocation Environmental control Biological, chemical & radiation safety Internal communication system

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Checklist 3. Staff a. b. c. d. e. f. g. h. i. 4. Number of personnel Qualifications Job description / responsibilities Responsibilities of Director i/c, tech Manager and Quality manager Training Competence Personnel health Personnel records Confidentiality of information

Non Partial Full Conformance Conformance Conformance


Equipment a. Eqpt requirement

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Checklist b. c. d. e. f. g. h. 5. Selection & validation Use Eqpt detail record and unique identification Calibration & maintenance Eqpt for storage of blood and component Computer system Breakdown of eqpt

Non Partial Full Conformance Conformance Conformance


External services: Supplies & reagents a. b. c. Policies & procedures Inventory control Supplier evaluation

6.

Process control a. Policies & validation of processes & procedures

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Checklist i. Traceability of blood ii. SOPs b. Donor lab i. Blood donation 1. 2. 3. 4. 5. 6. 7. 8. 9. Donor recruitment Pre-donation counseling Donor registration, consent & selection Phlebotomy procedure Post donation care Adverse donor reaction management Donation camps & drives Autologous transfusion procedure Donor notification for abn findings

Non Partial Full Conformance Conformance Conformance


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Checklist 10. 11. Record of donor Therapeutic apheresis

Non Partial Full Conformance Conformance Conformance


ii. Handling of samples & blood units 1. 2. 3. c. Samples for lab tests Identification & traceability Transportation

Component lab i. Sterility ii. Seal iii. Component preparation


d.

Quarantine & storage i. Refrigeration & Freezers for storage ii. Quarantine

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Checklist e. Labeling i. Labeling for whole blood ii. Instruction for Transfusion iii. Special requirements for component label f. Testing of donated blood i. Determination of ABO group ii. Determination of Rh (D) type iii. Determination of unexpected antibodies iv. Tests for TTIs g. Compatibility testing i. Request for blood & components ii. Sample receiving, acceptance & preservation iii. Pre-transfusion testing

Non Partial Full Conformance Conformance Conformance

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Checklist 1. 2. Testing of recipient blood Repeat testing of donor blood

Non Partial Full Conformance Conformance Conformance


iv. Issue of blood / component 1. 2. 3. 4. 5. 6. Issue Re-issue Urgent requirement Selection of blood & component for transfusion Massive transfusion Neonates

v. Record of recipients vi. Transfusion related advises 1. Informed consent

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Checklist 2. 3. 4. 5. 6. Identification of recipient & donor unit Supervision Administration Transfusion practices guidelines Special consideration for a. Red cell tfn b. FFP c. CP d. SDP e. Platelets & leucocytes f. Irradiation h. Transfusion reaction & evaluation i. Error prevention

Non Partial Full Conformance Conformance Conformance


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Checklist ii. Immediate complication iii. Delayed Complications iv. Detection, reporting & evaluation of tfn reaction i. j. k. Documentation in transfusion service Histo-compatibility testing Quality control for reagents i. ABO & Anti D ii. Reagent cells iii. Red cell panel iv. Anti-human globulin reagent v. Bovine serum albumin vi. Enzyme reagents vii. HBsAg, HCV, HIV I & II

Non Partial Full Conformance Conformance Conformance


---------------------- NOT APPLICABLE ---------------

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Checklist viii. Tests for syphilis ix. Normal saline & buffer solutions x. Blood component l. m. Proficiency testing programmes BMW i. Protection of blood bank personnel against lab infection ii. Safety in lab iii. Disposal of blood and lab material 7. Identification of deviations and adverse events with control of non-conformance a. b. Policies & procedures when non-conformance is detected Procedures component for released non-conforming blood

Non Partial Full Conformance Conformance Conformance


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Checklist c. 8. Preventing recurrence of non-conformance

Non Partial Full Conformance Conformance Conformance

Performance improvement a. b. Addressing complaints Corrective action i. Root cause analysis ii. Implementation and monitoring resulting from corrective action iii. Documentation of corrective action c. Preventive action changes

9.

Document control a. b. c. Procedure for control and review of documents Document required Maintenance of documents in computer software

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Checklist 10. Record a. b. c. Record identification Quality and technical records Record retaining period

Non Partial Full Conformance Conformance Conformance


11. Internal audit & management review a. b. c. d. Policy & procedure for internal audit & management review Procedure for internal audit Agenda and procedure of management review meeting Documentation of internal audit and management review

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