Process or performance improvement is often discussed

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Kerry Ramsey
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1 Process Improvement in Transfusion Medicine Ongoing efforts to decrease costs in the clinical laboratory make continuous process improvement especially important in difficult economic times. Process improvement can result in decreased workload, cost savings, and increased customer satisfaction but is an abstract concept in and of itself. To illustrate the steps of process improvement, we applied them to our blood component retrieval policy. By identifying the problems with the current system, proposing and implementing solutions, and measuring the effects before and after revamping the process, we have been able to show impressive reductions in the number of component retrievals initiated, the number acted on, wasted components, and customer complaints, all of which translate into cost savings. Once the cycle is completed, it begins anew. There must always be continuous process improvement. (Arch Pathol Lab Med. 1999;123: ) Process or performance improvement is often discussed as one means of adapting to the enormous changes, both fiscal and technological, that are currently occurring in the clinical laboratory. The alteration of a process to achieve efficiency can result in numerous benefits, including decreased workload, cost savings, and increased customer satisfaction. 1 In fact, an emphasis on process improvement is most important in difficult economic times. 2 The concept of process improvement can seem somewhat abstract; however, if applied to a real process, its benefits can become concrete. The example of process improvement that follows is our experience with streamlining the blood component retrieval (CR) process in our blood center. CR PROCESS The CR process is a system that allows blood centers to withdraw blood components that, potentially, may present risk to a transfusion recipient. The process may also be known as market withdrawal. Several facets of the CR process are regulated, 3 5 while others are common sense. The latter are carried out voluntarily by blood centers to protect the safety of the blood supply (and obviate medicolegal problems). The process can be complex, particularly as the volume of collections, and thus the number and Presented at the College of American Pathologists Conference XXXIII, Transfusion Medicine Performance Improvement, which was cosponsored with the American Association of Blood Banks, San Francisco, Calif, August 20 22, Reprints: Patricia M. Kopko, MD, Sacramento Medical Foundation Blood Center, 1625 Stockton Blvd, Sacramento, CA One Blood Center s Approach Patricia M. Kopko, MD; Paul V. Holland, MD types of CRs at a large regional blood center, increases. Retrieval of blood components that are potentially dangerous to recipients is beneficial; retrieval of those not presenting an increased risk is wasteful and costly in terms of lost components and may result in unnecessary work and confusion for hospital transfusion service (laboratory) customers. The process of retrieval of blood components is initiated when a unit of blood is identified as possibly being unfit for transfusion. There are a variety of reasons why a particular blood donation, and/or prior donations from a particular donor, may not be appropriate for transfusion (Table 1). When a blood center receives information from a donor, either at the time of the next attempted donation or after donation, that would have made the donor ineligible to donate had the information been available at the time of donation, a CR is initiated. An example of postdonation information triggering retrieval is a health care worker who remembers, subsequent to several donations, that he or she had a patient needle stick exposure several months ago that he or she had forgotten to tell prior interviewers. Since this donor would not have been eligible if this information had been known, due to the risk of potential exposure to human immunodeficiency virus and hepatitis, any blood components that are available and still unused should be withdrawn from inventory (at both the blood center and hospital transfusion services) for the safety of transfusion recipients. If a donor tests positive on a current blood donation for any of the viral markers used to screen blood donations, retrieval of in-date components from prior donations is recommended, functionally required by the Food and Drug Administration (FDA). 3 5 If an error in the manufacturing process of a unit of blood is discovered, the unit must be retrieved. Additionally, if a patient has a serious reaction to a blood component, the remaining components from that donation may have to be retrieved. For instance, if a patient has a septic transfusion reaction due to bacterial contamination of a platelet concentrate, the packed red blood cells and fresh frozen plasma from that donation should be retrieved. When a CR is initiated, the appropriate components need to be withdrawn from the market (ie, prevented from use). Any components that are still under the control of the blood center are quarantined to prevent release. Components that are potentially in a client hospital s inventory must be returned. The hospital transfusion service is notified that a particular component should not be transfused, if it has not already been used. The hospital is asked to confirm if the unit is still available or if it has been transfused. If the component is still in inventory, the Arch Pathol Lab Med Vol 123, July 1999 Blood Center Process Improvement Kopko & Holland 569

2 Table 1. Examples of Reasons for Component Retrieval 1. Donor calls back to: a. report illness b. report exposure to human immunodeficiency virus or hepatitis c. report travel to a malarial area d. request that donation not be used 2. Current donation tests positive for viral marker 3. Error is found in the manufacturing process 4. Patient had a septic reaction to a component hospital is asked to quarantine the component and either destroy it or return it to the blood center. When the CR is initiated and components are quarantined, it is often carried out based on preliminary information to control the product while the information is further investigated by the blood center to determine both the appropriateness of the CR and the ultimate disposition of the quarantined unit(s). The hospital transfusion service is notified of the initial reason for the market withdrawal, but often needs to be notified of the final outcome of the investigation as well, particularly if a blood component had already been transfused. An example of this is a frequent plasma donor who now tests repeatedly reactive in the screening test for the hepatitis B surface antigen. There can be up to 60 plasma donations that are still in the hospital or blood center inventory. Based on FDA recommendations, all the plasma donated in the last year is retrieved and quarantined pending the outcome of more specific confirmatory testing. 3 If the confirmatory testing results are negative, then the quarantined units can be released for transfusion. However, if the donor is confirmed positive for hepatitis B, the plasma from previous donations that has not been transfused is either destroyed or may be used for research. Additionally, hospitals that transfused plasma donated by this particular donor in the last year are notified that the donor subsequently was confirmed positive for hepatitis B so that they may notify and test transfusion recipients for evidence of hepatitis B virus infection and consider prophylaxis if they so choose. This latter notification is not required by the FDA. 3 Because the safety of the blood supply is involved in the CR process, the system needs to be as foolproof as possible but still needs to be simple, rapid, and cost-effective. However, the process in our center had focused primarily on safety without examining the CR process as a whole, which has additional ramifications, including impact on other blood center operations and hospital customers. As the number of blood donations at our blood center increased, the CR process became unwieldy and cumbersome. We decided that we needed to examine our CR system in its entirety and attempt to identify areas for potential improvement. We elected to apply process improvement to CR at our blood center as a practical exercise. PROCESS IMPROVEMENT STEP 1: IDENTIFY THE PROBLEM(S) Using our approach to revamping the CR process, we can illustrate an application of process improvement in one part of the laboratory, the blood bank. The first step in process improvement is to identify the way(s) the current system is not meeting expectations. We identified several problems, both external and internal, with the CR process of our blood center. The external complaints were primarily from customers who were unhappy with our lack of flexibility in our approach to the CR process. We received complaints because we treated every CR, no matter the cause, as immediate. We also treated all CRs with equal importance. Our procedures specified that we had to attempt to retrieve components even if they were not in-date and had been transfused up to 5 years before the CR. Additionally, our customers complained that our turnaround time, from initiation to final notification, was too long. Internally, our problems with the CR process were even more complex. The treatment of all CRs as immediate was a great burden to our hospital services department because they were expected to drop everything to retrieve components that often had long since been transfused. The work flow of the process was extremely complex and involved numerous staff in various departments (Figures 1 and 2). This complexity led to several additional problems with locating and tracking CRs, because many different staff members could handle the paperwork of the CR. In fact, CRs were often lost (usually buried on someone s desk), leading to unnecessary rework. The complexity of the process also led to long turnaround times as the CR worked its way through the system. The final internal problem identified as part of the process of retrieving blood components was unnecessary loss of product, which led to a negative financial impact on the blood center. Components were lost (unavailable for transfusion) for several reasons. Numerous unneeded CRs were initiated because there was no medical evaluation of the necessity of the CR early in the process. Medical review was only performed at the end of the process. In addition, all related components were retrieved, not just those affected by the reason for the CR. For instance, although notification of a donor s travel to a malarial area requires CR of red blood cells and platelets, but not plasma, we retrieved all components, including the plasma. We felt that this problem was due to the lack of critical medical evaluation of the reason for the CR early in the process. We were also losing product because of the long turnaround times. By the time a CR worked its way through the system and received evaluation by a blood center medical director for potential release of components, the components had often expired. PROCESS IMPROVEMENT STEP 2: PROPOSE AND IMPLEMENT SOLUTIONS The first part of the next step in process improvement is to propose solutions to address the problems identified; the second part of this step is to implement the chosen solution(s). All departments affected by the process should have input into possible solutions and the changes proposed and then attempted. In this part of the process, means should also be established to measure the efficacy of the corrective actions as well as identify any new problems or issues with the improvements. Several actions were proposed and then certain ones taken to correct the problems with the CR process. We stopped treating all CRs as needing immediate and urgent attention. We separated the CRs into two classes: a group that needed to be dealt with urgently and another group that needed CRs to be performed as soon as possible (ie, quarantine and initial customer notification occurring within 72 hours). 570 Arch Pathol Lab Med Vol 123, July 1999 Blood Center Process Improvement Kopko & Holland

3 Figure 1. Work flow of original component retrieval (CR) process. Triangles indicate decision points; rectangles, actions. Arch Pathol Lab Med Vol 123, July 1999 Blood Center Process Improvement Kopko & Holland 571

4 Figure 2. Work flow of original component retrieval (CR) process continued. Triangles indicate decision points; rectangles, actions; and FDA, Food and Drug Administration. Information on CRs that requires immediate attention includes infection with, or possible exposure to, human immunodeficiency virus; exposure to, or diagnosis of, hepatitis; fever, chills, vomiting, or diarrhea with 24 hours of donation; and donor hotline calls when the donor indicates that he or she does not want his or her blood used, but does not specify a reason for this postdonation call. When a CR that fits into the immediate category is initiated, the hospital services department immediately retrieves the appropriate blood components based on defined medical criteria (Table 2). Any CR information received that is not clearly urgent, but is of concern, is referred to the medical director on call for a decision on whether immediate action needs to be taken. Instead of retrieving all components donated in the last year, or 5 years, we decided that it would be more appro- 572 Arch Pathol Lab Med Vol 123, July 1999 Blood Center Process Improvement Kopko & Holland

5 Table 2. Medical Directive for Immediate Component Retrievals Component Retrieval Information Symptoms of fever, chills, vomiting, or diarrhea within 24 h of donation Call from the donor stating, Don t use my blood Donor exposure to hepatitis or human immunodeficiency virus Not defined but may represent a recipient safety issue Retrieve All components of the unit in question (most recent donation) Platelets back 5 d, red blood cells back 42 d, cryoprecipitate and plasma back 1 y Platelets back 5 d, red blood cells back 42 d, and cryoprecipitate and plasma back 1 y or retrieve all components back to initial exposure (whichever time frame is shorter) Refer to on-call physician for direction priate to follow FDA recommendations and retrieve only those components that were still in-date and potentially available for transfusion. This allowed both our facility and our hospital transfusion services to stop wasting time and effort determining the disposition of long-expired components. In-date was defined as 5 days for platelets, 42 days for red blood cells, and 1 year for fresh frozen plasma and cryoprecipitate. If the FDA recommendation defined a shorter period for CR (eg, 3 months for human immunodeficiency virus 1 antigen), this period was used. 5 We greatly simplified the work flow of the CR process, in part by assigning a CR coordinator who is responsible for guiding the CRs through the system (Figure 3). This individual directly hands-off CRs to the next employee responsible for an action needed in the process. The desired action is performed and the CR paperwork is returned to the CR coordinator. In addition, we decreased the number of staff responsible for performing actions in the CR process. This combination of changes has greatly decreased the difficulties of tracking and locating CRs and has virtually abolished the problem of lost CRs. Further, the CR turnaround was decreased so that in-date components could be released from quarantine, if appropriate to do so. For nonimmediate CRs, the decision of the appropriate components to retrieve, if any, is accomplished in one of two ways. For commonly occurring reasons for CRs, a medical directive that details which components to retrieve has defined an algorithm for the CR coordinator to follow. Commonly occurring CRs include, for example, repeat reactive viral marker tests and postdonation information about a diagnosis of cancer, exposure to hepatitis or human immunodeficiency virus, and travel to a malarial area. Those CRs falling outside this specified algorithm are reviewed by a medical director before retrieval. Our final alteration of the CR process was moving the timing of the medical review of the CRs. Instead of a nurse or a medical director reviewing a CR for appropriateness at the end of the process, after numerous components had been retrieved unnecessarily, a physician reviews all CRs up front that do not clearly fit into the defined medical directive for CRs. This change was made possible by the fact that all CRs are no longer treated as immediate. There is now time in the process for the CR coordinator to deliver an entire day s worth of nonimmediate CRs to a medical director for review, before any retrieval of components. This has resulted in numerous CRs being canceled at the medical review step and has greatly decreased the number of components retrieved unnecessarily. It also allows for early release of components that were quarantined inappropriately or unnecessarily. This is particularly important for platelet products, because they expire 5 days after donation. PROCESS IMPROVEMENT STEP 3: MEASURE THE IMPACT OF THE SOLUTION(S) The third step in process improvement is to measure the effect(s) of changing the process. Quantifying the effects of the changes and determining both the benefits and improvements and fallout and unanticipated impacts are essential. Measurements to determine effectiveness need to be made before and after implementation of changes in the process. The changes made to the CR process have had a dramatic impact on the number of CRs and the cost of the CR process. In the fourth quarter of 1996, before implementation of any of these changes, 441 CRs were initiated. Because all these were treated as immediate, they were all acted on. To measure the effects of the changes in the CR process and to quantify the process improvement, we evaluated the same parameters during a similar period after changes were implemented. In the fourth quarter of 1997, there were only 281 CRs initiated, with approximately the same total number of units drawn. Now, only 156 of these actually needed any retrieval action. This represents a 36% reduction in the number of CRs initiated and a 65% reduction in the number of CRs acted on. Not only did the total number of CRs acted on decrease, so did the number of components retrieved. Table 3 shows the actual components retrieved in the fourth quarter of 1997 compared with the components that would have been retrieved before this process improvement. Overall, there was a 67% reduction in the number of components retrieved. The most dramatic differences are seen with platelet and red blood cell components. This is primarily due to the fact that we are no longer attempting to retrieve red blood cells and platelets beyond their expiration date and the relatively short shelf-lives of these components compared with plasma products. We estimated that, on average, each CR needed 3 employee hours to complete under the old CR system. After the process improvement implementation, we found that it now takes about 1 hour per CR. For the 1 year period before the changes in the CR system (10/96 9/97), there were 1039 CRs initiated. Assuming a 36% reduction in the number of CRs initiated, a 2-hour reduction in employee hours worked per CR and an average hourly wage (including benefits) of $22.30, the CR process has saved our blood center approximately $ in salary expenses (Table 4). We also found that there was less product wastage due to blood components expiring before their release because the CRs are being turned around more rapidly, although the extent of this has been difficult to quantify. Finally, customer satisfaction has increased. As mentioned previously, before beginning this process improvement program, several of our customers had complained that we were attempting to retrieve expired components, that we treated all CRs as urgent when most were not, and that our turnaround times were too long. To date, since implementing the changes described, we have not Arch Pathol Lab Med Vol 123, July 1999 Blood Center Process Improvement Kopko & Holland 573

6 Figure 3. Work flow on new component retrieval (CR) process. Triangles indicate decision points; rectangles, actions; and FDA, Food and Drug Administration. Table 3. Retrieved (actual), No. Not retrieved, No. Total, No. Reduction, % Fourth Quarter 1997 Component Retrievals Actual Plus Those Not Required to Be Retrieved Red Blood Cells Cryoprecipitate Fresh Frozen Plasma Jumbo Fresh Frozen Plasma Recovered Plasma Platelet Concentrates Platelet Apheresis Total received a single complaint about our CR process. Instead, we have received both praise and a few inquiries about our new approach. Once the cycle of process improvement has been completed, it begins anew. Identification of residual problems, or new ones created, starts over. Solutions are proposed, agreed on, and implemented. Then, remeasurement of efficacy, or lack of efficacy, is carried out to assess the degree of process improvement (eg, lack of rework, cost savings, and decreased complaints). By closely examining the CR system in our blood center and looking for ways to improve the process, we have simplified a complex system and saved money in terms of both wages and lost product, decreased turnaround times, 574 Arch Pathol Lab Med Vol 123, July 1999 Blood Center Process Improvement Kopko & Holland

7 Table 4. Estimated Cost Savings of Process Improvement to Component Retrieval System Component Retrievals (New System) [Component Retrievals (old system)] (1 % reduction) (1039 Component Retrievals) (1 0.36) 665 Component Retrievals * 374 fewer component retrievals are initiated Total Savings (Component Retrievals Not Initiated) (3 h/component Retrieval) (Cost of Labor) (Component Retrievals) (2 h/component Retrieval) (Cost of Labor) (374 Component Retrievals) (3 h/component Retrieval) ($22.30/h) (665 Component Retrievals) (2 h/component Retrieval) ($22.30/h) $ and essentially eliminated customer complaints. We continue to evaluate this process improvement to determine if our goals are being accomplished. If not, the process will be modified further, with input from those affected; there must be ongoing evaluation for continuous process improvement. For example, at this point, we are considering our ability to capture information electronically by putting the entire CR system on our internal, linked personal computer system. This would allow all employees with CR responsibilities to access the status of CR information and potentially perform their CR tasks via their personal computers. References 1. West NR. Observations on outcomes. Health Care Division Newsletter, American Society for Quality, Health Care Division. 1998: Laszlo GP. Cost reduction through quality improvement. Quality Manage Forum. February 1998: Recommendations for the quarantine and disposition of units from prior collections from donors with repeatedly reactive screening tests for hepatitis B virus (HBV), hepatitis C virus (HCV) and human T-lymphotropic virus type I (HTLV-I). Rockville, Md: Dept of Health and Human Services, Food and Drug Administration; 1996: Department of Health and Human Services, Food and Drug Administration. Current good manufacturing practices for blood and blood components: notification of consignees receiving blood and blood components at increased risk for transmitting HIV infection. 61 Federal Register (1996). 5. Recommendations for donor screening with licensed test for HIV-1 antigen. Rockville, Md: Dept of Health and Human Services, Food and Drug Administration; 1995:2 15. Arch Pathol Lab Med Vol 123, July 1999 Blood Center Process Improvement Kopko & Holland 575

TRANSFUSION ASSOCIATED DISEASE, RECALL, OR COMPLICATION INVESTIGATION POLICY I. FATALITIES AND COMPLICATIONS ASSOCIATED WITH TRANSFUSION:

TRANSFUSION ASSOCIATED DISEASE, RECALL, OR COMPLICATION INVESTIGATION POLICY I. FATALITIES AND COMPLICATIONS ASSOCIATED WITH TRANSFUSION: I. FATALITIES AND COMPLICATIONS ASSOCIATED WITH TRANSFUSION: A. TRANSFUSION RELATED FATALITY: FDA and MEDIC must be notified immediately, and subsequently in writing, when a possible transfusion related