|Year : 2016 | Volume
| Issue : 2 | Page : 61-65
Clinical audit of fresh frozen plasma usage in a Tertiary Care Hospital of Islamabad, Pakistan
Usman Waheed1, Muhammad Taimoor2, Lubna Naseem2, Hasan Abbas Zaheer1
1 Department of Pathology and Blood Transfusion Services, Shaheed Zulfiqar Ali Bhutto Medical University, PIMS, Islamabad; Safe Blood Transfusion Programme, Ministry of National Health Services, Regulation and Coordination, Government of Pakistan, Pakistan
2 Department of Pathology and Blood Transfusion Services, Shaheed Zulfiqar Ali Bhutto Medical University, PIMS, Islamabad, Pakistan
|Date of Web Publication||6-Sep-2016|
Department of Pathology and Blood Transfusion Services, Shaheed Zulfiqar Ali Bhutto Medical University, PIMS, Islamabad; Safe Blood Transfusion Programme, Ministry of National Health Services, Regulation and Coordination, Government of Pakistan
Source of Support: None, Conflict of Interest: None
Introduction: The supply of blood components in Pakistan far outstrips the demand. In addition, appropriate and rationale use of blood components is not widely practiced. To optimally utilize the limited supply of blood products, it is important to identify and define the gaps in practices and system. The specific aim of the study was to document the practices of the use of fresh frozen plasma (FFP) in a premier tertiary care hospital of Islamabad, Pakistan.
Materials and Methods: The study was carried out on 107 randomly selected patients who received FFPs in various clinical units of the Shaheed Zulfiqar Ali Bhutto Medical University Hospital from March to October 2014. Information was retrieved from the transfusion request forms and evaluated according to the American College of Pathologist guidelines for the use of FFP. A questionnaire was also developed for interviewing the senior doctors from each specialty to have their feedback about the transfusion services provided. Nineteen clinicians were randomly selected for this purpose.
Results: Requests from 107 patients for 460 FFPs were studied (actual number of FFPs issued was 278). Nearly 68.3% (n = 73) of the patients were males and 31.7% (n = 34) were females. Majority of the units were requested from thalassemia and hemophilia center (40.6%). The patients enrolled in the study had multiple disorders, majority being with coagulation disorders at 40.1% (n = 43). Nearly 98.5% (n = 138) of the request forms were brought to blood bank by the patient attendants. Seventy-three (52%) FFP units were appropriately transfused while 67 (48%) were inappropriately transfused. The most inappropriate use of FFP was seen in Mother and Child Health Centre (MCHC), Oncology, Emergency and Casualty, and the most appropriate use was seen in thalassaemia centre, paediatric units, and medical intensive care unit. Clinician interviews indicate poor knowledge base and inappropriate practices.
Conclusion: The study highlighted the inappropriate use of FFPs in a tertiary care hospital and threw light on poor transfusion practices and the lack of implementation of the principles of haemovigilance in the utilization of FFPs. Specific recommendations include, administrative intervention with regular screening of requests by blood bank doctors and senior doctors of the departments using FFP and establishment of guidelines in departments regarding the use of blood components including FFP.
Keywords: Clinical, fresh frozen plasma, Pakistan
|How to cite this article:|
Waheed U, Taimoor M, Naseem L, Zaheer HA. Clinical audit of fresh frozen plasma usage in a Tertiary Care Hospital of Islamabad, Pakistan. Glob J Transfus Med 2016;1:61-5
|How to cite this URL:|
Waheed U, Taimoor M, Naseem L, Zaheer HA. Clinical audit of fresh frozen plasma usage in a Tertiary Care Hospital of Islamabad, Pakistan. Glob J Transfus Med [serial online] 2016 [cited 2019 Jan 16];1:61-5. Available from: http://www.gjtmonline.com/text.asp?2016/1/2/61/189851
| Introduction|| |
Blood transfusions are an important part of medical management in the modern health-care system. It has been recognized as one of the eight key lifesaving interventions that should be available in health-care institutions offering emergency obstetric care. Blood and blood products are collected from healthy donors after conducting an appropriate selection procedure and special clinical laboratory tests. The blood components that are available in most developing and developed countries include whole blood, red blood cell concentrates, platelet concentrates, frozen fresh plasma (FFP), and cryoprecipitate. Other components that are not routinely available in many transitional and low human development index countries include aphaeresis-derived components, leukocyte-reduced and leukocyte-irradiated cellular blood components, and plasma derivatives such as factor VIII concentrate, albumin, and immunoglobulins.
FFP transfusions are among the most “high risk” of all blood component transfusions in relation to transfusion reactions. At the same time, FFP also has the distinction of being very commonly transfused for inappropriate indications. This approach toward FFP transfusion was highlighted by the 2005 SHOT report, which showed that 24 out of 69 transfusion reactions were due to FFP, and out of these, 33% had no proper clinical indication of transfusion. FFP is indicated for prophylactic use only when the prothrombin time (PT) or partial thromboplastin time (PTT) is 1.5 times the midpoint of normal or higher. Inappropriate and indiscriminate use of FFP has implications in respect to economics, workload burden as well as safety of the recipients.
To promote the rational use of blood components, particularly FFPs, the present study was conducted. The study helped define quality gaps in practices and procedures of in-hospital transfusion services. Specifically, the study assessed the appropriate rational use of FFP by various clinical departments. The study also determined the pattern of FFP usage and evaluated the haemovigilance system.
| Materials and Methods|| |
This study was carried out at the Shaheed Zulfiqar Ali Bhutto Medical University Hospital, a leading health sciences institute in Islamabad. The hospital blood bank provides transfusion services to all hospital patients and also requests coming from other hospitals.
One hundred and seven patients who received FFP transfusions from March to October 2014, at different clinical units of the hospital, were randomly selected for the study. All units were exclusively requested by doctors. Requisition forms were assessed along with indications for transfusion. Information was retrieved from the transfusion request forms. Physicians were contacted, wherever required, to clarify the indication for the transfusion of FFP. All the request forms were evaluated according to the guidelines for the use of FFP provided by the American College of Pathologists. The FFP transfusion as a volume expander or to increase wound healing was considered contraindicated (due to the availability of all the alternatives and risks associated with FFP transfusion). The indications for FFP transfusion included:
- Coagulopathy due to a congenital or acquired deficiency of coagulation factors, with active bleeding or other invasive procedure and with the presence of anyone of the following values, i.e., PT >18 s, activated PTT (APTT) >55–60 s, and coagulation factor assay of <25% activity;
- Massive blood transfusion: Replacement of more than 1 blood volume (approximately 5000 ml in a 70 kg adult) within several hours with sign of a coagulation deficiency (as in 1) with continued bleeding;
- Reversal of warfarin effect: If immediate hemostasis was essential to halt active bleeding or prior to emergency surgery or an invasive procedure (PT >18 s; international normalized ratio >1.6);
- If there was a documented congenital or acquired coagulation factor deficiency or prophylactically for surgery or invasive procedure; and
- Plasma exchange for thrombotic thrombocytopenic purpura or hemolytic uremic syndrome.
Request forms were accordingly categorized as appropriate or inappropriate. A separate pretested questionnaire was used for interview with senior doctors from each specialty with the purpose to take their feedback about the services provided by the blood bank. Nineteen clinicians were randomly selected from all specialties for this purpose. For FFP preparation, the blood was collected from healthy individuals, mostly replacement donors, and processing was done according to the standard practices.
Blood bank requisition forms were studied and patients' age, sex, clinical diagnosis, requesting department, indication for FFP transfusion, history of previous transfusions, number of units transfused, and coagulation profile were noted. In cases where the PT/APTT results were not available in transfusion requisition forms, these were either retrieved from the laboratory data or performed with the newer sample. Units containing lower volumes in paediatric recipients were considered to be 1 unit in our study. Data were analyzed according to the wards from where requisitions were received for all FFP transfusions and were divided into appropriate and inappropriate requests. Indications for transfusion requests were evaluated and divided into various diagnostic categories. Results were further classified into appropriate and inappropriate requests. This included nondisclosure of patient's identity and the use of a unique ID number. All the data collected were entered into the SPSS version 20 (IBM SPSS Statistics for Windows, Version 20.0. Armonk, NY: IBM Corp.) and analyzed. The variables (e.g., age, gender, PT, APTT) were analyzed for frequencies, ranges, and mean values.
| Results|| |
A total of 107 patients were enrolled randomly in the study from March to October, 2014. The total numbers of FFPs requested were 460 while the number issued was 278. The majority of the patients were males, i.e., 68.3% (n = 73) whereas females were only 31.7% (n = 34). The male to female ratio was 2.1:1. The mean age of patients was 16.2 years. The age range was from 1 day to 80 years. The number of requests received and FFPs issued to various clinical units is shown in [Figure 1] and [Figure 2], respectively. The patients enrolled in the study were diagnosed with multiple disorders [Table 1]. Almost all the request forms of FFPs of 98.5% (n = 138) were brought to the blood bank by the patients' attendants. The FFP units were transported from blood bank to the ward by the patients' attendants in hands supported by polythene bag/paper of 98% (n = 137) or cooler of 2% (n = 3). The FFPs were thawed in the ward settings supervised by the medical officer (MO) in charge. Various methods were followed for thawing FFPs including putting the FFP under running tap water in 35% (n = 49), on shelf at room temperature in 52% (n = 73), in water bath in 10% (n = 14), under the pillow in 1.4% (n = 2), under the blanket in 0.7% (n = 1), and under armpit in 0.7% (n = 1) of the patients. In most of the cases, transfusion was monitored by the medical doctors in 65.7% (n = 92) who also recorded transfusion notes in the patient files while rest of the 34.3% cases (n = 48) were monitored by the staff nurse, who also wrote the transfusion notes.
The transfusion time of all the 278 FFPs issued was recorded and the mean was calculated. The average transfusion time for a FFP unit was 18 min. Out of 278 transfusions, only four patients showed any immediate signs and symptoms of transfusion reaction which was itching and urticaria. These four patients belonged to thalassaemia centre. All these reactions were managed by the MO. None of these reactions were reported to the blood bank. All the FFP units issued were transfused to the respective patients, and no bag was left untransfused. The empty bag was discarded in normal waste and not returned to the blood bank. All the request forms were evaluated according to the guidelines for the use of FFP provided by the American College of Pathologist in 1994. Request forms were accordingly categorized as appropriate or inappropriate. Seventy-three (52%) FFP units were appropriately transfused while 67 (48%) were inappropriate. The most inappropriate use of FFP was seen in Mother and Child Health Centre (100%), Oncology (100%) and Emergency and Casualty (100%). The most appropriate use of FFP was seen in thalassaemia centre (including haemophilia centre) paediatric units (75%), and medical Intensive Care Unit (40%) [Table 2].
A total of 73 patients were found with known coagulation factor deficiency or deranged coagulation profile, 46 of them were hemophilics and rest of the 27 had other disorders resulting in deranged PT/APTT. The criteria for appropriateness of FFP utilization were PT >25 s and/or APTT >55 s. Pre- and post-transfusion samples were taken, and PT/APTT was done to measure the increment. The increment was observed in all these patients, but due to the persistence of infection/sepsis, prematurity, or liver disease, multiple transfusions were required.
Transfusion notes were recorded in the file at the commencement of transfusion only. The notes did not show the information related to completion of transfusion. The transfusion notes were written but were not complete in all cases studied. Only the signature of the nursing staff or doctor was observed.
Feedback from the clinicians was also taken through a questionnaire. The objective of this exercise was to correlate their knowledge base with transfusion practices adapted. Nineteen clinicians were randomly selected from all specialties for this purpose. The main problems highlighted by the clinicians were (1) issue of lesser number of FFPs from blood banks; (2) delay in the fulfillment of demand, especially in critical care unit cases; (3) transportation of the FFPs by the patient attendants; (4) attitude of the blood bank staff; (5) lack of communication between the requesting doctor and blood bank staff, and (6) nonstandardized volume of FFP. Majority of the doctors mentioned that the indications for FFP in their respective wards are for correction of coagulation factor deficiency and in patients with deranged coagulation profile. While answering a question about the methods of thawing for the use of FFP in wards, many clinicians mentioned several procedures that are not recommended and affect the quality of FFP components adversely. These included placing at room temperature, under running water tape, under the armpit, under the pillow, and under the blanket. As per the information obtained from the relevant doctors, the method of thawing of FFP in different clinical units was different. Only the PICU was using thawing water bath, the rest of the units were either using room temperature or running tape water to thaw the FFP. The usual method for thawing the FFP in plastic surgery unit was to put the FFP bag under the armpit of the attendant. Some of the units were using blanket or pillow to thaw the FFP.
| Discussion|| |
The pattern of blood usage is very different in countries where diagnostic and treatment options are more limited, with a much greater proportion of transfusions being given to women with obstetric emergencies and children suffering from severe anemia, often resulting from malaria and malnutrition. Whatever is the degree of development of the health-care system, transfusion is the only option for survival for many patients. Many patients do not have access to blood when they need it. Of the estimated 80 million units of blood donated annually worldwide, only 38% are collected in the developing world where 82% of the world's population live. The shortfall has a particular impact on women with complications of pregnancy, trauma victims, and children with severe life-threatening anemia. Up to 150,000 pregnancy-related deaths could be avoided each year through access to safe blood.
The availability of component therapy has increased the potential for misuse. Choosing an inappropriate component can alter the risk/benefit ratio or fail to correct the patient's problem. Internal audits form an integral part of quality control program in blood banks, like in any other organization. The current study has, therefore, documented the current practices of clinical use of FFP to develop recommendations, to formulate policies and strategies, to reduce the need for transfusion, to minimize unnecessary transfusions, and to ensure the safe and appropriate use of blood and blood products.
This study showed widespread lack of awareness about the appropriate use of FFP among doctors resulting in a high number of inappropriate requests. In spite of clear guidelines regarding blood component use, inappropriate prescriptions for various blood component use including FFPs are still very common. Auditing of transfusion practices is, therefore, very necessary to ensure that the scarcely available blood components are prescribed for the deserving patients. In most of the cases, the FFP was transported by the patient attendants, which is mainly attributed to the lack of hospital porters.
The average turnout time was 4 min which was very good. In this study, the attendant transported the FFP bags without any cold carrier box. It carries the risk of breakage of FFP bags as well, and it is not an advisable mode of transportation of FFPs. To maintain cold chain the bags must be transported by hospital attenders using carrier boxes.
Thawing water bath was available only in PICU. In rest of the units, FFPs were thawed at room temperature or by wrong method. Other wrong methods of thawing were under blanket, under armpit, and under the pillow, which are very risky and not advisable.
Regarding the appropriateness of FFP usage, our audit revealed generalized and widespread irrational use of FFP among our doctors in all the specialties leading to inappropriate use of FFP. As a result, patients not requiring FFPs were transfused FFPs and the needy patients missing out due to lack of availability of sufficient FFPs. The high percentage of inappropriate use in our study was similar to some other studies., This high percentage of inappropriate use is mainly due to lack of awareness of international guidelines. Two studies from India reported 78.2% and 67.37% inappropriateness in the use of FFPs, respectively,, and a study from South Africa reported  39.5% inappropriateness.
Some other studies also highlight the inappropriate use of FFP ranging from 21.3% to 83%.,, Another study which was conducted at the Armed Forces Institute of Transfusion, Pakistan, has revealed similar results, i.e., 56%. This was a study of 3 months and included 498 units of FFP for 118 transfusion episodes.
The qualitative analysis of findings from clinicians suggests a poor knowledge base of the clinicians in addition to poor practices of transfusion. The adverse events are underreported, and there is a lack of recognition of signs and symptoms of adverse events. In addition, the standard operating procedures (SOPs) are rarely followed.
It was commonly observed that the vital signs such as temperature and blood pressure were not recorded before and after transfusion. This can be harmful to the patients, as adverse reaction and fluid overload can lead to serious complications. Documentation and recording of vital signs is, therefore, mandatory to ensure safe blood transfusion. Gross discrepancies were observed regarding the transfusion notes, which reflect the lack of proper knowledge or very poor record of blood transfusion products.
Minor adverse reactions following transfusion of blood components to thalassemia patients are not uncommon. Reporting these minor reactions to the transfusion service needs a careful evaluation. However, in our study, the transfusion reactions were not reported to the blood bank on a prescribed form.
As observed in this study, the SOPs for blood transfusion reaction are not observed properly by the staff of the clinical units. Strict adherence to the standard protocol of hemovigilance system is the need of the time to provide safe blood transfusion to all the needy patients. The system for reporting adverse reaction must be strictly followed.
The study showed that in spite of the international guidelines provided for the use of FFP, it is still misused. This leads to the wastage of FFP, especially in a country like Pakistan where voluntary donor pool is finite. The misuse of FFP also deprives more needy patients and puts extra cost on the economy and disposes the patients to the risk of transmission of infections, particularly hepatitis B virus, hepatitis C virus, and HIV.
| Conclusion|| |
Current study reflected the inappropriate use of FFPs in a tertiary care hospital and threw light on poor transfusion practices and the lack of implementation of the principles of haemovigilance in the utilization of FFPs. Specific recommendations include, administrative intervention with regular screening of requests by blood bank doctors and senior doctors of the departments using FFP and establishment of guidelines in departments regarding the use of blood components including FFP.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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[Figure 1], [Figure 2]
[Table 1], [Table 2]