Six Sigma sticks patients less

Black belt project improved emergency department's processes for drawing blood

By Paul Barkley

Many of your patients hate needles. And if there are problems with the blood culture, repeated collections annoy them even more.

At Navicent Health in Macon, Georgia, the emergency department performs 10,000 blood cultures annually. And their contamination rate exceeded a national best practice benchmark, an institutional benchmark and a liberal emergency department benchmark of, respectively, 1 percent, 3 percent and 5 percent.

Blood cultures are an important and frequently deployed diagnostic tool in providing proper medical treatment and are commonly collected when a patient shows symptoms of septic shock, leukocytosis, fever, chills and suspected endocarditis. They also are frequently collected prior to initiating antimicrobial treatment in elderly patients or those with compromised immune systems.

All those factors combined to lead Navicent Health management to approve a Six Sigma black belt project charter in late 2014 to improve and standardize the processes associated with collecting blood cultures in the emergency department to decrease contamination rates. Figure 1 is a high-level SIPOC (supply, input, process, output, customer) diagram outlining the process.

Define

Contaminated blood cultures can cost hospitals a lot – both in terms of quality of patient care and monetary expenses. Previous studies of the cost of contamination have shown charges in the range of $2,000 per contaminant to more than $8,000 in excess charges associated with a single contaminated culture.

Applying the conservative $2,000 as a base multiplier means that achieving the institutional target rate of 3 percent would save Navicent Health more than $800,000 each year. Simply meeting the emergency department threshold of 5 percent would save $325,000 a year.

With the cost opportunity defined, the Six Sigma black belt team identified categories for three measures of impact: contamination defects, turnaround time (TAT) and labeling defects.

For contamination defects, evidence-based research supports the belief that contamination can be reduced by using the most effective antiseptic agents while using personnel who are dedicated to drawing blood cultures.

Turnaround time is defined as time intervals between steps within the process that were defined in the Navicent Health laboratory as follows:

• Order time: The time the physician or designee enters the order into the hospital information system
• Collect time: The time the blood culture specimen is collected from the patient
• Receipt time: The time the specimen is received in the laboratory
• Process time: The time the specimen is processed within the laboratory
• Login time: The time the specimen begins the testing phase within the microbiology lab
• Call time: The time a positive blood culture result is called to the physician or care-giver
• Final (result) time: The time the result is posted and all work is completed

Labeling defects include specimens submitted with an unspecified sample collection site, specimens that lack a time of collection or specimens that don't have the collector's identification. All are considered defective and incomplete.

The voice of the customer was determined by soliciting feedback through several focus groups that included patients and front-line staff, along with a survey of staff and physicians. The feedback was then refined and extracted to determine which elements were critical to quality (CTQ).

In evaluating the elements that were critical to quality, the team confirmed that a significant opportunity for improvement existed. Patients wanted their samples properly collected, labeled and processed with accurate results delivered as soon as possible. Collectors wanted access to proper collection kits and supplies. Physicians and care providers wanted ease of ordering, access to pre-analytical and post-analytical laboratory data, consultation and results at the earliest opportunity. Laboratory staff wanted properly labeled samples of sufficient volume, ordered appropriately and sent immediately after collection. The cumulative elements depicted a sampling system free of contamination, which required a "right the first time" approach in all facets to complete the task properly in a reasonable amount of time.

After developing the elements that were critical to quality, the key performance indicators (KPIs) were finalized by the team and customers to provide evidence of long-term value. Multiple KPIs were developed, including a number of TAT measures, utilization rate, overall contamination rate, labeling defects and call response metrics.

Measure

Initial KPI targets were set as follows:

• Overall contamination rate (5 percent or less)
• Utilization rate (17-21 percent)
• Positive culture calls completed within 60 minutes (greater than 90 percent)
• Average positive culture call time (less than 60 minutes)
• Collect to login TAT (less than 120 minutes, target of less than 105)
• Login to call TAT (less than 8 hours)
• Call to final TAT (less than 24 hours)
• Collect to final TAT (less than 132 hours)
• Labeling defects (reduce unspecified collections by 15 percent)

Blood culture contamination rates have been tracked by the institution for more than 20 years. Monitoring and measurement demonstrated that contamination rates within the emergency department varied, ranging between 5 percent and 11 percent annually, as detailed in Figure 2. Despite various training interventions and programs that showed initial improvement in reducing problems, gains were never maintained.

Previously, this was attributed to relatively high staffing turnover found in the emergency department. This is not an uncommon finding by other institutions that have studied root causes of high contamination rates within emergency centers.

In 2011, three years before the black belt team tackled the problem, the hospital had yet again renewed emphasis on training. This effort yielded short-term improvement for blood culture collections. Still, unacceptably high levels of contamination returned, creeping above 6 percent annually.

The American Society for Microbiology targets 1 percent as a best practice threshold for contamination, with zero contamination as the true goal. The Navicent Health Six Sigma black belt team was determined to make sustainable and significant improvements.

In 2014, the facility had collected more than 24,000 blood culture samples with 936 contaminants, representing an overall 3.89 percent institutional contamination rate. During the pre-implementation evaluation period of Jan. 1, 2014, through Oct. 31, 2014, the emergency department collected 10,124 blood cultures, with 9,447 meeting acceptability metrics. Defects per million opportunities (DPMO) was 66,871 with a Sigma level of 1.5 and a yield of 93.32 percent. The staggering discovery was that contaminated draws originating from the emergency department accounted for 82.4 percent of all the contaminants isolated in 2014.

Analysis of the 677 contaminated specimens drawn in the pre-implementation evaluation period were plotted across a 24-hour time span to determine shift distribution. When compared to patient visit distributions, it was determined that contamination distribution was consistent and represented overall patient visit and collection cycles; contamination was not confined to specific shifts or personnel.

Further examination of the 10,124 submitted emergency department samples identified 238 labeling defects, resulting in a DPMO of 23,508 and a long-term Sigma level of two. Pre-implementation TAT defects were also measured, representing a DPMO of 43,609.

Analyze

A team composed of supervisors and front-line staff was assembled from the emergency department, laboratory and pharmacy. The team took assignments back to their respective work areas and reconvened in four one-hour sessions over the course of two months of biweekly meetings to compile and present their findings and suggestions.

The team began to brainstorm potential root causes, using an Ishikawa diagram to collate suspected origins. Cause-and-effect analysis clearly identified that despite preconceived notions about the underlying reasons for poor performance, numerous unidentified root causes had severely curtailed the opportunity for success. Contamination was not just a matter of high turnover in emergency department staffing.

Despite significant focus centered on the process and the people performing collections, laboratory staff had not anticipated finding out that the process often suffered from insufficient supplies, materials and equipment. Additional costs of poor quality manifested itself across a broad array of disciplines in the form of waste associated with transport of unacceptable specimens, rework associated with repeat collections, false positive results and treatment delays.

Lurking behind the less-than-ideal process were hidden costs associated with extended turnaround times, excess inventory costs associated with pharmacy and laboratory supplies, excess time spent processing paperwork as well as costs associated with retraining. More important, of course, were the patients and providers who were unhappy and frustrated with throughput delays due to the poor process.

Turnaround time and date measurements for the project were exported from the hospital information system. Then they were converted into serial form (MM:DD:YYYY mm:hh) for use in ascertaining the various turnaround time intervals, allowing the team to compare the pre-implementation data with post-implementation data.

The team began the exercise of mapping out the existing process. Input from all the departments identified a fractured process that was not consistent across shifts and lacked standardization. The team immediately identified significant variations in techniques and supplies used.

For example, collection site, time and collector's initials were not routinely recorded, which led to confusion and an absence of important data that physicians need to determine the clinical significance of a positive result.

In addition, Clinical and Laboratory Standards Institute (CLSI) guidelines for blood culture collection favor the use of alcoholic chlorhexidine gluconate (CHG) for infants who are older than 2 months of age, children and adults, using it with care for premature infants and those under 2 months of age. In some cases, iodine-based disinfectants were being used when CHG was not readily available in the patient care areas.

The team also discovered that staff were not familiar with the need to disinfect the collection bottle tops with isopropyl alcohol prior to inoculation. Further exploration revealed that the emergency department's storage areas were sporadically stocked with the necessary items required to complete the blood culture collection accurately. Time studies revealed that it took the collector an average of 3 minutes just to find and retrieve the necessary supplies for blood culture collection.

With more than 1,000 collections a month, this delay accounted for more than 50 hours cumulative per month – all time wasted simply gathering supplies.

Improve

Since collection materials were not consistently available, the team concluded that it would be ideal to devise a locally assembled kit that included all the requisite components for collection. Commercial kits, while available, were not considered due to cost.

Microbiology staff were tasked with assembling more than 1,000 kits per month during off-peak work hours, a process that took just 10 hours a month total. This assembly process reduced the amount of time emergency department staff and phlebotomists had to search for supplies. This work redistribution accounted for approximately 480 hours, or an estimated $6,000 in annual department productivity savings.

To ensure a standardized process, each completed kit came with a color printed copy of instructions showing the detail and order of proper collection, as well as minimum sample volumes.

The emergency department management and front-line staff met with their peers to re-educate everyone on how important it was to properly identify the collection site and the time the collection was drawn. Additional emphasis was placed on using peripheral sites as the primary draw site, only using ports, lines and alternative sites when a peripheral stick could not be performed.

In the laboratory, the physical layout was reoriented to modify and update the existing space. This was completed in conjunction with a separate lean project, both of which benefitted from a more optimized specimen transport path.

The reconfiguration of modular casework by 90 degrees resulted in minimizing the number of steps by 52.3 percent between the workstations and specimen entry points – pneumatic tube stations, doors and specimen windows. For blood culture volume alone, this resulted in 132,000 saved steps, or approximately 22 hours of travel time annually.

This reduction in transport time decreased specimen dwell and cycle times, shortening the TAT between the sample receipt in the laboratory and the login time in the microbiology department. Additionally, pickup frequency by microbiology staff was increased to reduce logging delays and to decrease batching. These efforts helped the lab move closer to continuous processing.

These changes shaved 6 minutes and 15 seconds off the collect to login TAT and 1 hour 2 minutes and 24 seconds off the login to call TAT. This was an overall time savings of 33 minutes and 34 seconds on the collect to final report TAT for the immediate post-implementation phase.

During the project, laboratory staff were retrained on the requirement to call positive results within a 60-minute target. Previously, only 89 percent of calls were meeting this threshold. After completion, nearly 95 percent of calls met the threshold, with the average call time decreasing from 46 minutes to 24 minutes.

Finally, a phlebotomy pilot project began in the emergency department with the goal of demonstrating the impact dedicated phlebotomy resources would have on the contamination rate. While the project had lowered emergency department rates under the 5 percent threshold, the facility's internal phlebotomy rates generally hovered around 1 percent, indicating the potential for even more savings.

A phlebotomist was assigned four random evening shifts over a two-week period in November 2014, resulting in 33 sample collections over a cumulative 32 hours. None of the collected samples during the pilot period were contaminated, for a phenomenal zero percent rate. And the internal phlebotomy rate for the period of November 2014 was 0.93 percent in contrast to the 4.82 percent rate observed by emergency department staff.

It was determined that with an average of two to three specimens collected per hour/per day, it would require 8.4 full-time equivalents (FTEs) at an estimated annual cost of $230,000 to adequately staff phlebotomy resources to cover the emergency department on a full-time, 24-hour-a-day, seven- day-week basis.

Using defect reduction to generate cost avoidance projected that providing phlebotomy services in the emergency department would justify the return on investment. In November 2015, Navicent Health laboratory and nursing administrations partnered in securing the resources to staff the emergency department with dedicated phlebotomy staff. The emergency department blood culture contamination average rate of 4.3 percent in 2015 dropped to 1.61 percent in 2016, while the overall institutional rate dropped from 3.03 percent to 1.44 percent in the same, respective years.

An additional positive byproduct of adding phlebotomy resources was a decreased work demand on emergency department technicians, registered nurses and physicians, allowing them to focus on other direct patient care activities.

Control

The laboratory had historically tracked and trended blood culture contamination rates, reporting the findings in multidisciplinary meetings and laboratory quality meetings. Follow-up was usually too late for corrective action to provide much of an impact.

Using dashboards with timelier TAT monitors and control charts, the process is now more actively reviewed, with outliers sent to the appropriate department leadership. Within the laboratory, shift-by-shift performance on resulting and call TAT metrics are monitored and are aligned to personnel performance goals, with contamination identified and tracked per individual phlebotomist.

Since project inception in November 2014, the emergency department blood culture contamination rate has been in control under the historical 5 percent thresholds for 28 consecutive months, under the 3 percent institutional rate for the past 14 consecutive months and under the American Society for Microbiology best practice target of 1 percent for three of the last nine months.

In Figure 3, the tests of hypotheses show statistically significant long-term sustainable improvement in reducing contaminants and labeling defects.

Cleaner results and cost reductions

During the project, average call times were reduced 39.1 percent (18 minutes), which translated to 263 hours of quicker notifications. Defect reductions saved $4,898.31 in lab collection supplies.

Turnaround time and labeling improvements saved 6,752 hours in potential length-of-stay reduction. Immediate contaminant rate reduction from 6.68 percent in October 2014 to 4.82 percent saved $34,000 in the month of November 2014 alone. Savings in calendar year 2015 totaled $614,000, with more than $1.17 million in cost avoidance in calendar year 2016, netting savings of $940,000 after subtracting the cost for adding full-time equivalent phlebotomy resources.

Cumulative net cost savings since project inception in November 2014 have totaled more than $1.588 million in cost avoidance using the conservative cost of $2,000 per contaminant expense as a benchmark. In addition to the cost savings, significant gains in patient result quality and clinical benefit were accomplished by improving accuracy and timeliness. Figure 4 charts the results.

Using updated dashboards and earlier intervention, now the laboratory identifies problems in near real-time fashion, providing timelier feedback on defective collections. This provides a more collaborative relationship between the laboratory and the emergency department, which generates positive feedback and prevents future errors. Measurements of the key performance indicators afforded another layer of in-depth oversight that maintained success and prevented nonconformities.

Finally, the voice of the customer and stakeholder input was crucial to achieving team buy-in and establishing the framework for implementing sustainable, long-term change.

Paul Barkley has been with Navicent Health for more than 25 years and currently serves as the clinical operations manager in the Department of Pathology and Laboratory Medicine. He is certified as a medical technologist by the American Society for Clinical Pathology and holds professional affiliations and memberships with the American College of Healthcare Executives, American Association of Blood Banks, Clinical Laboratory Management Association and Georgia Chapter of HIMSS. He is a certified lean Six Sigma green belt by the Institute of Industrial and Systems Engineers. Barkley earned an MBA from Mercer University, a B.S. in biology degree from Georgia Southern University, a B.S. in medical technology from Augusta University and an associate of applied science, electronics and telecommunications from the Community College of the Air Force.