Measuring the quality of therapeutic apheresis care in the pediatric intensive care unit

Measuring the Quality of Therapeutic Apheresis Care inthe Pediatric Intensive Care UnitJeffrey B. Sussmane,1* Dan Torbati,1 and Howard S. Gitlow2

1Division of Critical Care Medicine, Miami Children’s Hospital, Miami, Florida2Department of Management Science, School of Business Administration, University of Miami, Coral Gables, Florida

Our goal was to measure the quality of care provided in the Pediatric Intensive Care Unit (PICU) during Thera-

peutic Apheresis (TA). We described the care as a step by step process. We designed a flow chart to carefully

document each step of the process. We then defined each step with a unique clinical indictor (CI) that repre-

sented the exact task we felt provided quality care. These CIs were studied and modified for 1 year. We meas-

ured our performance in this process by the number of times we accomplished the CI vs. the total number of CIs

that were to be performed. The degree of compliance, with these clinical indicators, was analyzed and used as a

metric for quality by calculating how close the process is running exactly as planned or ‘‘in control.’’ The Aphe-

resis Process was in control (compliance) for 47% of the indicators, as measured in the aggregate for the first

observational year. We then applied the theory of Total Quality Management (TQM) through our Design,

Measure, Analyze, Improve, and Control (DMAIC) model. We were able to improve the process and bring it

into control by increasing the compliance to > 99.74%, in the aggregate, for the third and fourth quarter of the

second year. We have implemented TQM to increase compliance, thus control, of a highly complex and multidis-

ciplinary Pediatric Intensive Care therapy. We have shown a reproducible and scalable measure of quality for a

complex clinical process in the PICU, without additional capital expenditure. J. Clin. Apheresis 27:43–50,

2012. VVC 2011 Wiley Periodicals, Inc.

Key words: apheresis; children’s hospital; clinical indicators; pediatric intensive care unit; performanceimprovement; quality, total quality management

INTRODUCTION

The challenge to define, measure, improve, andcontrol the quality of care provided in health care isparamount. The Pediatric Intensive Care Unit is par-ticularly difficult with complex patients, and familymembers who are intensively involved in both clini-cal and nonclinical considerations. The application ofTherapeutic Apheresis (TA) is a complex procedure,provided in the PICU, involving patients, intensiveclinical activity, multiple hospital services, equip-ment, family, and staff (1–9). The nature of the TAprocess, with a relative brief duration allowed us tolearn how to design and apply a scientific methodwith the hope of receiving useful data. We felt thatTA would provide a microcosm of PICU perform-ance. We designed a study to define and measure theprocess that actually delivers the care to the patient.We described the process with an exhaustive andthoughtful list of actions that was created by thepatient/family/healthcare team. Our goal is to studywhether Total Quality Management (TQM), with theDesign Measure Analyze Improve and Control(DMAIC), method of Performance Improvement iscapable of measuring the Quality of Care during

Therapeutic Apheresis in PICU at Miami Children’sHospital (1,2). Our experience suggests that thismodel may be useful as a metric for the measure-ment of the quality of care of other therapiesthroughout the Hospital without capital expenditure.

Donabedian proposed observing the structure, pro-cess, and outcomes of medical care as a means ofmeasuring quality [1]. The Institute of Medicine, in itssix quality aims for improving care, defines quality‘‘as the degree to which health services for individualsand populations increase the likelihood of desiredhealth outcomes and are consistent with current profes-sional knowledge’’ [2]. This incorporates two of Dona-bedian’s three elements; measuring outcomes, andassessing the adherence to processes that are proven,while agreeing with patient preference or professional

*Correspondence to: Jeffrey B. Sussmane MD, MBA, FAAP, FCCP,

FCCM, Division of Critical Care Medicine, Miami Children’s

Hospital, 3100 SW 62nd Avenue, Miami, FL 33155. E-mail:

[email protected]

Received 2 December 2010; Accepted 11 October 2011

Published online 17 November 2011 in Wiley Online Library

(wileyonlinelibrary.com).

DOI: 10.1002/jca.20318

VVC 2011 Wiley Periodicals, Inc.

Journal of Clinical Apheresis 27:43–50 (2012)

consensus, i.e. family directed care [3]. The processis a collection of interacting components that trans-form inputs into outputs toward a common aim,commonly called a mission statement [4]. Demingdeveloped a famous systematic analysis and mea-surement of ‘‘process’’ for assessment of quality[5]. Following the contributions of Juran and God-frey, this became know as ‘‘Total Quality Manage-ment’’ (TQM) [6]. A specific statistical techniqueof TQM known as ‘‘Six-Sigma’’ is a tool to measure

the distribution or variation of outputs in a process.Six-Sigma measures the variation in a process. Thegoal is to achieve continuous improvement of the pro-cess, impact the outcome and increase satisfaction [4].A simplified but commonly utilized Six SigmaPerformance Improvement Model is the ‘‘Define,Measure, Analyze, Improve, and Control’’, (DMAIC)model [4]. This step-by-step measurement tool evalu-ates a predefined process, and quantifies whether theprocess is in control [7].

TABLE I. Clinical Indicators that Are Critical to Quality (CTQ) Before Procedures

Staff-related procedures Patient-related procedures Equipment-related procedures

Attending notified Core temperature within normal limits (WNL) Precautions to avoid equipment damage

Fellow notified Blood pressure WNL Machine start up functioning

Nurse manager notified Heart rate WNL Alarms Checks complete

ECLS coordinator notified Respiratory rate WNL Sterile technique

Patient’s ID verified Oximetry WNL Proper flow achieved

Procedure verified Rspiratory evaluation WNL Manitor Max AC ratio

Patient’s diagnosis verified Neurological evaluation WNL AC ratio validated

Consent for first procedure, if not emergency Hematocrit>25gm/dL Flow rate monitored

Family receive education brochure Platelets >75,000

Explain procedure to patient/family PT <14.5 before first procedure

Explain equipment to patient/family PTT <40 before first procedure

Proper hand washing I Ca >1.0

Pre-Apheresis orders complete Electrolytes WNL

Transfusion consent Allergies verified

Patient weight Checked

TABLE II. Clinical Indicators that Are Critical to Quality (CTQ) During and After Procedures

Staff, patient procedures and equipment

Staff-related procedures Patient-related procedures Equipment-related procedures

Family questions answered Patient VS within normal limits (WNL) IV fluids started

Volume processed recorded Patient VS WNL after starting pheresis Access and return line checked

Patient clinically evaluated every 15 minutes Patient oxymetry WNL Machine function WNL

Patient family teaching No evidence of hypercalcemia Catheter function WNL

Patient kept at bed rest 1 hr post-procedure Patient VS WNL after procedure Plasma pump adjusted

Patient’s catheter site evaluated Post -procedure CBC obtained Machine shut down apropriately

Inquires regarding family needs Electrolytes WNL, 2 h after procedure Machine cleaned appropriately

Post-procedure heparin flush 200 u/cath port PO4 WNL 2 h post-procedure Appropriate machine maintenance

Mg11 WNL 2 h post-procedure Access and return line function WNL

I Ca >1.0, 2 h post procedure No evidence of clots in line

TABLE III. Check List of Clinical Indicators that Are Critical to Quality (CTQ) for Stem Cell Harvesting, Blood Bank Paperwork,

and Catheter Placement

Stem cells harvesting only South-FL (S-FL) blood bank paperwork Catheter placement only

Patient WBC>0.5 X 109 (500 on CBC) Product handed to S-FL blood bank courier Consent for catheter

Patient 10–14 days of g-CSF Product log documentation completed Catheter ordered

No colloid prime required Infection screening markers <30 days Patient NPO

No blood products ordered Viability measured Procedure ‘‘Time-Out’’ performed

Strobe checked every 15 minutes Successful engraftment Sedation protocol

CD34 count obtained Blood products ordered Patient VS WNL during sedation

Hospital’s flow cytometry notified (weekdays) Waste bag checked Central line placement protocol

Product appropriately labeled, signed by 2 RN Placement volume calculated Red cell exchange only

Community blood bank of South FL notified Blood primed for Pt <18 kg Spectra-therm checked

44 Sussmane et al.

Journal of Clinical Apheresis DOI 10.1002/jca

METHODS

The protocol for this study was approved by West-ern Institutional Review Board (IRB). We adapted aTQM tool, described as Design, Measure, Analyze,Improve, and Control (DMAIC). It was implementedas follows.

Design

The Family Directed Care for the Apheresis Processwas designed by the Extracorporeal Life Support Team(ECLS), and implemented to evaluate the apheresistherapy program at Miami Children’s Hospital. Theprocess was initially described with an exhaustive andthoughtful list of individual actions that was created bythe patient/family/healthcare team. This list is repro-duced in the table attached (Tables I, II, III). This listwas not intended to be all encompassing or applicableto many different centers. We chose common parame-ters for a nonspecific Pediatric Intensive Care patient.If a patient did not meet one of these items they weredocumented as such or, may not have qualified for theprocedure. A complete flow chart was then created todocument each individual action of the entire process(Figs. 1, 2, and 3). A ‘‘checklist’’ was then created,from this list of actions/goals [8]. The checklist wasfurther refined to reflect finite collectable key clinical,operational, and patient/family data that the team estab-lished to reflect the directed values, events and goals.This checklist was recorded real time during the care.This data was documented, without the use of anypatient identifying information. This data was listed as‘‘clinical indicators’’ (CI). These CIs were designed todocument desired and recognized events and outcomes.The events and outcomes (CIs), used to measurepatient and family values were obtained with directfamily interviews, before, during and after the therapy.The events and outcomes described by these CIs aredefined as ‘‘Critical To Quality’’ (CTQ) variables ofour process [7]. The ECLS team reviewed the CIs after1 year for relevance, accuracy and ability to reflectfamily centered health care excellence. The CIs werethen modified to reflect paradigms accepted by theECLS team.

Measure

We measured our ability to provide quality by meas-uring the degree of compliance with each CI during theapheresis process. Thus, the selected CIs measure whatour family directed care team identified as importantfor the delivery of quality service QTC [4]. The CIswere recorded at the time of the process without theuse of any patient identifying information. The clini-cians responsible for the procedure completed this listof CIs. The data obtained by the bedside clinician was

verified by a separate bedside clinician present in thePICU, the clinical Apheresis coordinator, and the direc-tor of the Apheresis service, whenever possible. Thedata was collected blindly and entered into a database.We used the number of CIs, performed successfullyper total number of CIs, as a quantitative measure ofcompliance (performance) or ‘‘yield’’. The yield is theproportion of CI performed correctly per total numberof opportunities to perform correctly [7]. The qualityof performance, as measured by the number of CIs suc-cessfully performed divided by the total number of CIs,was collected quarterly. Data was collected following asimplified processing algorithm, as presented in Figures1, 2, and 3.

Analyze

We collected, reviewed, and analyzed the data forthe first year with the entire team before the implemen-tation of TQM. The team then thoroughly reviewedand modified the CIs to provide the desired quality ofcare. We outlined these patient/family directed goals inaccordance with the Institute of Medicine and thePicker Institute [2,9].

Improve

The ECLS team reviewed the CIs for relevance, ac-curacy, and ability to reflect family centered healthcare excellence, consistent with the DMAIC model [7]every 4 months throughout the next year. ThroughTQM the CIs were modified to reflect paradigmsaccepted by the ECLS team.

Control

We continued the TQM process improvement modelfor 2 consecutive years and measured the compliancewith the defined process. We continued TQM until theprocess was in control for two consecutive quarters.We defined control with compliance to CIs > 99.5%.

Finally, we compared all TA compliance clinicalindicators with <95% compliance in the first year withthe same clinical indicators in the second year, usingthe nonparametric Mann Whitney U test (two tailed),where P < 0.05 was considered statistically significant.

RESULTS

The list of Clinical Indicators, used for measuringcompliance, is presented in Tables I, II, III. We meas-ured 76 general CIs and 20 procedures specific CIs foreach patient. This totaled over 6,850 separate CIs over2 years. The Apheresis process was in compliance for46.7% of the CIs, as measured by the documentationof performance of CIs in the aggregate for the firstyear. Through applied TQM for the first quarter of thesecond year, the measured compliance (yield) increased

Measuring Quality Care 45


to 81.8%. The process further improved to 91.03% forthe 2nd quarter, and 99.74% in the 3rd and 4th quar-ters. We then defined this process in Control. The

results of the CIs with less than 95% compliance, for thefirst year were compared to the results of the same CIscompliance with the 3rd and 4th quarter of the second

Fig. 1.

46 Sussmane et al.


Fig. 2.



year. This comparison demonstrates a highly significantimprovement in compliance with these particular CIs(P < 0.0001), two tailed nonparametric Mann-WhitneyU-test (Table IV). This supports the analysis of a pro-cess in control with the significant improvement in theCIs that had less than 95% compliance in the first year.

DISCUSSION

The Institute of Medicine has reported a seminalfinding that only 15 % of medical errors are the result

of inadequate individual performance and other 85%can be attributed to the system (structure) or processes[2]. Rubin described the advantages of measuring aprocess in health care and then comparing it to out-comes [10]. The advantages of measuring the processinclude; providing feedback for quality improvementinitiatives, it is less risky, and the data is quicker tocollect. These investigators pointed out that there needsto be a strong relationship between the process and theoutcome, and that patient care is more about outcomes[10]. The disadvantage is that process measurement

Fig. 3.

48 Sussmane et al.


may be too specific and not reveal the comprehensivecare. An Advisory Commission on Consumer Protec-tion and Quality in the Health Care Industry, estab-lished in 1999, has recommended a Strategic Frame-work for a national quality measurement and reportingsystem [11]. This framework articulated the ‘‘criteriaand process by which common measures should beselected, and to illustrate the results of applying thisapproach to one clinical area’’ [12]. Quality improve-ment data in the adult literature has emerged with theuse of these systems [13].

Many hospitals have developed apheresis programsdue to the growing success and increase therapeuticuses of this complex procedure [10,16–23]. We imple-mented a performance improvement tool to measurethe quality of our apheresis program in Miami Child-ren’s Hospital PICU. The study was designed to assessoverall improvement in the process by measuring thecompliance with the many clinical indicators, which

are directly relevant, to our family directed care goals,during the apheresis procedure. Our family directedgoals were driven by the current practice of medicinethat requires the delivery of family directed qualitycare. The team continuously interviewed patients andfamilies to obtain authentic, current information regard-ing the family’s values and perception.

The work of Balint introduced the term patient-cen-tered medicine [22]. The Picker Commonwealth Pro-gram (subsequently the Picker Institute) further coinedthis concept for Patient-Centered Care in 1988. Theyoutlined the core concepts of patient/family directedcare as: dignity and respect, information sharing, par-ticipation and collaboration, in the implementation,evaluation and the delivery of health care [9,23].Kohn et al. in an Institute of Medicine report [23]defines patient-centered care as ‘‘care that is respect-ful of and responsive to individual patient preferences,needs and values, and ensuring that patient valuesguide all clinical decisions.’’ The International Health-care Initiative also focused on these central themes:involving patients and families in the design of care;reliably meeting the patient’s need; informed decision-making [23]. The American Academy of PediatricsCommittee on Hospital Care summarizes the family-directed care as ‘‘grounded in collaboration amongpatients, families, physicians, nurses, and other profes-sionals for the planning, delivery, and evaluation ofhealth care as well as in the education of the care pro-fessionals [3].

Our results demonstrates that a simple Six-SigmaTQM DMAIC model can be utilized to design, mea-sure, analyze, improve, and control the performanceand quality of a highly complex clinical process. Thespecific and statistically significant improvement in theCIs that were below 95% compliance over the courseof a year confirms the achievement of a process in con-trol. The goal of having a process in almost perfectcontrol in less than 2 years, and delivery high qualitypatient/family directed health care was achieved, with-out capital investment. Our data is consistent with otherquality improvement observations, investigating the useof community-based services for children and youthswith special health care needs [13]. These investigatorshave show that patient satisfaction scores rose from the10th to the 95th percentile, length of stay decreased by50%, medical error rate fell by 62%, discharges (vol-ume) increased 15.5%. The nursing staff vacancy ratefell from 7.5 to 0%, with a waiting list of potentialnurses, and a positive change in perceptions of the unitby faculty, staff, and house staff [13].

Our rigorous pursuit to reduce variation for this crit-ical process obtained continuous and breakthroughimprovements of over 99% in compliance. This mayimpact the bottom and/or top line of the organizationand increase customer satisfaction.

TABLE IV. Apheresis Compliance Measuring Clinical Indicators

with <95% Compliance in 2008 Compared with 2009

Clinical indicators

Compliance (%)

2008 <95% 2009

Family service education brochure 94 100

Family questions answered 94 100

Pre-apheresis order complete 94 100

Patient neurological evaluation 94 100

Electrolytes within normal limits (WNL) 94 100

Patient respiratory WNL 94 100

Monitor maximum AC ratio 94 100

Plasma pump adjusted 92 95

Explain procedures to family 91 100

Explainequipment to family 91 100

Catheter function WNL 91 95

Spectra-therm checked 90 100

Patient platelets >75,000 89 95

Electrolyte WNL: 2 h post-procedure 88 100

Ionized Ca >1.0: 2 h post-procedure 88 100

Consent (if not emergency) 87 100

IV fluids started 81 96

Post-procedure CBC obtained 80 100

Patient NPO 76 100

Procedure ‘‘time-out’’ performed 71 100

Patient VS (WNL) after sedation 70 100

Sedation protocol 69 100

Patient NPO 2 h post-procedure 68 96

Patient PTT <40 64 95

Patient hematocrit <25 gm/dl 54 91

Mg11 2 h post-procedure 50 94

PO4 2 h post-procedure 50 91

Patient PTT <14.5 48 90

No Evidence of hypocalcemia 29 91

Mean 78.4 97.5****

Standard deviation 17.9 3.5

Median (50 percentile) 88 100

95% Confidence intervals 71.6–85.2 96.2–98.8

****P < 0.0001, comparing compliance in 2009 with 2008 compli-

ance (two-tailed nonparametric Mann-Whitney U-test).



CONCLUSIONS

We have shown a reproducible and scalable measureof quality for a complex clinical process in the PICU,without additional capital cost.

ACKNOWLEDGMENTS

The authors wish to acknowledge the endless hoursof dedication to our families and patients that is givenby our outstanding Extracorporeal Life Support Team.Without their participation this project could not becompleted.

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Measuring the quality of therapeutic apheresis care in the pediatric intensive care unit