Blood Products

The transfusion service at Miami Children’s Hospital (MCH) was discarding numerous blood products including; platelet pheresis, red blood cells, fresh frozen plasma, and Cryo due to improper product handling and storage. In the last Quarter of 2008, 43 platelet pheresis units were discarded. The reasons for the waste of blood products included;

short product life;
episodic utilization–difficult to maintain appropriate stock levels;
a designated and autologous policy was too broad and allowed for numerous unneeded donations from family and friends;
FDA guidelines for all first degree designated products called for irradiated units which cannot be returned for credit if not transfused;
current transfusion services policies did not properly address blood products storage practice in remote areas (operating room and cardiovascular intensive care unit); and
a culture which accepted blood product waste a necessary cost for Miami Children’s Hospital Operations.

Definitions
Blood product waste may be defined as the discarding of potentially lifesaving Blood products due to expiration or improper handling and storage of product. Platelet pheresis is the process of collecting thrombocytes, a component of blood involved in blood clotting which is performed by a device used in blood donation that separates the platelets and returns other portions (primarily plasma) of the blood to the donor.

A serious complication of blood transfusions includes graft versus host disease. Transfusion associated graft versus host disease (TA-GVHD) is a rare but usually fatal complication of transfusion. It occurs when donor lymphocytes engraft in a susceptible recipient. These donor lymphocytes proliferate and damage organs. The mortality rate of TA-GVHD approaches 100 percent.

The most commonly reported setting for TA-GVHD is immunocompetent recipients of blood from biologically related (directed) or HLA identical donors. The mainstay of preventing TA-GVHD is gamma irradiation of blood products. Irradiation of blood products is undertaken using a dedicated blood irradiator with a long half-life gamma emitting source. The purpose of irradiating the blood product is to remove white cells that often carry the various viruses and antibodies. Irradiated Blood Products have a shortened expiration which leads to expiry of units if careful monitoring, storage and tracking are not observed.

Lean is a people driven, tool based, process improvement methodology that can be applied to any organization. Leans focus is on the elimination of waste so that all activities/steps in a process add value from the customer’s perspective.

Value stream mapping or VSM is map of all activities in a process, both value added and non-value added that are required to bring a product or a service to the Customer.

Kaizen is a Japanese word used in lean methodology to identify an opportunity for improvement

Methods
MCH has always been dedicated to continuous improvement and in 2008, our CEO, Narendra Kini, MD, and other hospital executives invested in training a select group of employees on Lean methodology and attained significant results.

Working with a consulting group, our staff improved patient satisfaction while achieving $500,000 in recurring savings, $1 million in avoidable capital and $1 million in one-time savings.

In October 2009, MCH won four Global Six Sigma & Business Improvement Awards, more than any other organization, for our success in embracing Lean as an organizational priority. In 2010, MCH created the project management office. Since its inception, all initiatives are led by MCH staff.

The administration’s vision was to imbed Lean into our culture. Today, to quote our Chief Operating Officer, Martha McGill, “it’s the way we do, everything we do.” In 2012, MCH enjoys a sound balance sheet, rising customer satisfaction ratings and powerful position in the highly competitive South Florida marketplace.

Opportunities

Our transfusion service department received numerous designated products per patient, the products were not all transfused and resulted in waste of product and money.
The products included a large number of platelet pheresis which is very expensive.
The optimal inventory of platelet pheresis was difficult to maintain due to episodic utilization and short product life.
Current designated/autologous policy was too broad and allowed excess donations and did not have clear guidelines for releasing products to general inventory.
All first degree designated products by FDA guidelines must be irradiated, unused irradiated units cannot be returned to donor’s facility for credit adding to our annual waste blood product waste of $140,000.
Current transfusion services policies did not address blood product storage practice in remote areas (i.e., operating room and cardiovascular and pediatric intensive care unit).
Culture of senior leaders, nursing, medical technologist and physicians which accepted blood product waste as a necessary cost for the hospital operations.

Process

Figure 1. Click to enlarge

A Value Stream Map (VSM) (Figure 1) was conducted with a cross-functional team of staff members (stakeholders) from CICU, CV, OR, Hematology-Oncology and the Laboratory. The team members met for approximately 18 hours over a period of 3 weeks to complete the VSM and they streamlined workflow steps, reduced “waste” or non-value added activities and identified Kaisens (opportunities for improvement).

Information about the current state process was collected through live observations of the process by team members and review of electronic data. Stakeholders understanding their impact to the entire process lead to a higher level of accountability and resulted in a successful reduction of blood product waste.

Figure 2. Click to enlarge

To ensure that meetings were value added, guidelines and checklists were used throughout the process (Figure 2).

CICU, CV, OR and Hematology-Oncology implementation steps taken included:

Educated the staff on the cost associated with blood product wastage.
Weekly huddles conducted at shift change for a consecutive 7 days discussing the amount of wastage of products being reported to the unit from the blood bank and the associated costs related to this wastage.
Monthly staff meetings conducted where the wastage of products is discussed and staff input and recommendations are shared with the blood bank.
Information sharing of available blood products at the unit level is a key component to preventing wastage. Nurses discuss the availability of blood products for their particular patient in their handoff report to one another. Care assistants discuss all blood products currently residing in the unit blood refrigerator, as well as the expiration dates of the products. Care assistants then review with the RN about the need to keep the products on the unit based on patients’ conditions and acuity level. If blood products can be returned, the Care assistant then transports the products back to the hospital’s blood bank.
Incorporation of available blood products at the unit level in the handoff report from one caregiver to the next, and inventory of products being placed in the blood refrigerator by personnel for specific patients.
Logging of products–Once placed in the unit’s blood refrigerator, a patient transported to the CV unit from the OR with products accompanying the OR, the OR personnel logs the products onto a clipboard with the patient’s medical record information and number and type of products being placed in the refrigerator with the date of placement. This is a quick glance check system that helps track the blood products, especially traveling from one unit to the next, and the date the products were placed in the refrigerator for that particular patient.
Designated blood product policy allowed patients and family members to donate numerous designated products increasing blood product inventory. Most units were irradiated and by FDA guidelines cannot be returned to donor’s facility.

Outcomes and Sustainability
In the last 2 years, we have saved more than 80 units of platelet pheresis from being discarded. In 2008, the cost of blood product waste in our laboratory was just over $140,000.00. Through the implementation of Lean methodology, in 2009, the annual cost of blood product waste was reduced to $59,508. Through continued process improvement and the sustainability of our Lean methodology, we further reduced our blood product waste in 2010 to $52,574 (Figure3).

Lessons Learned

Use metrics throughout process and continuously monitor.
Involve bench level staff in the Lean process.
Obtain commitment to improve the current process from all stakeholders.
Maintain open lines of communication.
Be transparent to sustain improvements.

Aleida Gavallas is Lean process manager, Martha Delgado is laboratory quality assurance manager and Connie M. Fischman is nurse manager of the Congenital Heart Institute, Miami Children’s Hospital.

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