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Improvement in cost-effectiveness and customer satisfaction by a quality management system according to EN ISO 9001:2000
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     Department of Cardiovascular Surgery, Charite – University Medicine Berlin, Luisenstr. 65, 10117 Berlin, Germany

    Presented at the 34th meeting of the German Society for Thoracic and Cardiovascular Surgery, Hamburg, Germany, February 13–16, 2005.

    Abstract

    The implementation of a quality management system (QMS) according to EN ISO 9001:2000 has proven to be possible for cardiac surgery departments. However, it remains unclear if a QMS can help to improve quality as indicated by cost-effectiveness and customer satisfaction. To control costs for medical goods and laboratory investigations an internal control system for the allocation of resources was implemented. Laboratory costs and medical goods per open heart procedure were investigated in the years 2000 to 2003. In terms of customer satisfaction, repeated questionnaire-based evaluation of referring physicians was obtained from 2001 to 2003 and the influence of repeated interventions on various aspects of communications was investigated. Costs of medical goods could be reduced by 6.1%, and for laboratory investigations by 35% per operation. Additionally, customer satisfaction could be increased efficiently with respect to accessibility and postoperative communication. By the introduction of a process based QMS, efficient control of the costs of medical goods and laboratory investigations could be achieved. Once a year repeat evaluation of satisfaction of advising physicians has proven to be a valuable tool in the process of continuous improvement.

    Key Words: Quality management; ISO 9001:2000; Cardiac surgery; Cost efficacy; Customer satisfaction

    1. Introduction

    Quality management systems (QMS) are valuable tools for continuous improvement in various aspects of quality. After revision of EN ISO 9001:2000 (ISO 9001) [1], the application of this uniform standard on university clinical departments of cardiac surgery has proven to be possible [2]. However, there is only limited information if this improves quality.

    In terms of cost-effectiveness, limited resources and the introduction of a diagnosis related group (DRG)-based reimbursement system, forces all German hospitals to cost efficient management [3]. Therefore planned allocation of resources as defined by ISO 9001 is mandatory: competence, awareness and training, infrastructural aspects (buildings, workspace, environment, equipment and goods), work environment, information and suppliers and partnerships [1]. Medical goods represent roughly 8.1%, and laboratory investigations 4.9% of the total costs of German university hospitals [4], respectively. Control of these costs, therefore, represents a valuable instrument in terms of cost-effectiveness.

    Customer satisfaction is defined as

    ‘customer's perception of the degree to which the customer's requirements have been fulfilled’ [5].

    This assumes that the customer's requirements are known and communicated between the clinical department and the customers as represented by different groups like advising patients, physicians, relatives, reimbursement companies, employees and external partners.

    Repeated evaluations by questionnaires are valuable tools for advising physicians and clinics [6]. Improvement in satisfaction of cooperating clinics by planned interventions on structures and processes, therefore, is another objective of this study.

    2. Material and methods

    The process of the implementation and certification of a QMS was formerly described in detail by Benholz et al. [2]. A system for resources control and continuous evaluation of satisfaction of cooperating cardiologists, which form one of the most important groups of customers in cardiac surgery, were implemented as described below.

    2.1. Control of medical goods and laboratory investigations

    An interface to an external advisor was declared (Fig. 1). A detailed 12-month analysis of consumed medical goods such as prostheses, setup for extracorporeal circulation, catheters, disposables, dressings, drugs and blood products covering 85% of the total costs of medical goods, was given in monthly reports and discussed in detail in grand rounds including the director of the department, the quality representative and the head nurses. These reports also included clearing of all internal services such as anesthesia, radiology, laboratories and others. After extensive team discussion numerous changes in purchasing and processes were implemented. Control of success of these measures was maintained by the next rounds. As a result of this repeated assessment of resources, yearly budget negotiations of the department with the administration gave the amount of money to be spent.

    To reduce laboratory costs, fixed laboratory profiles were declared (Table 1), and were used as a standard at admission, during the postoperative course and at discharge.

    Time of intervention of this system of control was available on 1 January, 2002. The years 2002 and 2003 were the observation period, the years 2000 and 2001 formed the control period. Mean costs for medical goods and laboratory investigations per operation using extracorporeal circulation was calculated. To avoid bias the pattern of operations in the years 2000 to 2003 was monitored. Additionally, 30-day mortality for coronary artery bypass grafting and all operations in the years 2000 to 2003, were compared to the mortality in all German heart centers [7].

    2.2. Satisfaction of co-operating cardiologists

    During the implementation of the QMS, different groups of customers were declared and routine processes of the active evaluation of their satisfaction were defined. Besides patients, one of the most important groups of customers is formed by the cardiologist advisors and clinics. A questionnaire with 10 questions covering availability, admission dates, communication, individual requirements overall satisfaction and perception of patient's satisfaction, was prepared and sent to 50 co-operating cardiology departments and referring cardiologists with a catheter laboratory facility.

    Answers were graded from 1 (very satisfied) to 5 (not satisfied at all). Weighted mean satisfaction was calculated with respect to the number of patients admitted in the term of evaluation. Reference period was the evaluation of 2001 during the implementation of the QMS, and changes of mean satisfaction in 2002 and 2003 were investigated. For this study, two questions were isolated and the following modifications of processes and structures were implemented:

    Accessibility of the department during the day and at night.

    To increase the accessibility of the department changes included, a strict distinction between separate secretaries and their responsibilities, clear communication of responsibility for urgent patients within the department and to all cooperating cardiologists, mobile phones etc.

    Postoperative communication.

    Although all patients left the department with a complete letter of discharge a lack of operation records was complained of by several referring cardiologists. Intervention therefore included different aspects of documentation: responsibility for writing operation records within 3 days by the surgeon, providing additional hardware and software, declaration of a quality goal (80% operation records available at discharge) and continuous surveillance of this in a sample of 10% of all patients.

    Also timely information about patients who died was required. To achieve 90% of letters for those patients written within 7 days, interventions included responsibility for this letter, control in mortality rounds and frequent reports by the quality representative.

    3. Results

    3.1. Medical goods

    Costs for medical goods were 3,053.49 per case in 2000. After a slight increase of 1.3% up to 3,076.12 from 2000 to 2001, a reduction by 3.3% down to 2,975.34 was achieved in 2002 and a further reduction by 2.9% down to 2,888.76 in 2003. The total absolute reduction was 187.36 from 2001 to 2003, representing 6.1%. During the same period, the pattern of operations showed a continuous decrease of isolated coronary interventions with an increase of valve interventions (Fig. 2).

    3.2. Laboratory investigations

    The introduction of obligatory laboratory profiles in the beginning of 2002 led to a decrease in laboratory costs from 2001 ( 168.3 per case) to 2002 ( 101.9 per case) by 33.5%, which remained stable in 2003 ( 106.0 per case). Most redundant end parameters were CRP (savings 32,377), protein analysis including albumin ( 16,074) and parameters of liver function ( 25,930). Total absolute savings in laboratory costs were 35.2% ( 108,651) from 2001 to 2002.

    3.3. Thirty-day mortality

    Thirty-day mortality of all operations (Table 2) showed a slight increase in 2001 and reached the German overall mortality of 4.2%. In 2002 and 2003 there was a decrease in our hospital to 3.7% while German overall mortality remained higher. Coronary artery bypass grafting operations were the most frequent operations where mortality increased in 2001 to a level below the German mortality. In the following years German, as well as our mortality rates, decreased significantly.

    3.4. Satisfaction with accessibility of the department

    The return of the questionnaire-based evaluation of satisfaction of cooperating cardiologists continuously increased from 57.1% in 2001, to 65.4% in 2002 and 70.6% in 2003. There was a steady improvement in satisfaction with the accessibility during the day from 1.70 in 2001 to 1.33 in 2003 and at night from 2.00 to 1.77, respectively (Fig. 3).

    3.5. Satisfaction with postoperative communication

    The interventions showed effect documentation as displayed by a continuous increase in the rate of operation records available at discharge from 48.7% in 2002 to 81.8% in 2003 (Fig. 4). Additionally, timely written letters for the information about deceased patients increased from 48.2% in 2002 to 88.6% in 2003 (Fig. 5). Mean satisfaction with postoperative communication improved from 2.84 in 2001 to 2.04 in 2003 (Fig. 3).

    4. Discussion

    Increasing expectations as well as economic pressure have led to a broad discussion about quality in healthcare. Meanwhile there is consensus about the necessity for modern concepts of management in terms of all aspects of medical treatment. QMSs and their certification may additionally represent a marketing factor in the increasing competition in healthcare.

    Planning of all measures is essential for the performance of any QMS. Long-time strategical adjustment has been the privilege of a few big healthcare providers [8]. Facing dramatic changes in economic frames by the implementation of a diagnosis-related group-based reimbursement system [9], now every hospital has to adopt methods of strategical adjustment; modern QMSs may help by their process and customer-oriented approach.

    4.1. Control of medical goods and laboratory investigations

    From a report by the Federal Statistical Office Germany [4], non-personnel costs in 2000 covered roughly 40% of the total costs of 7.2 billion of 35 German university hospitals. Patient-related costs of 1.7 billion represent 62% of non-personnel costs and almost 24% of the total costs (Fig. 6). Of these patient-related costs medical goods, as represented by supply and dressing, consumptives and operation materials, covering 1/3 of patient-related costs and 8.1% of all university hospital costs [4], were reported by the system of internal control as described above. The 6.1% decrease of costs for medical goods in our study from 2001 to 2003 was not explained by the pattern of operations since the shift towards cost consumptive operations, in terms of expensive implants, would have turned around this development. Furthermore, facing a rate of price increases in Germany of 1.4% in 2001 and 2.0% in 2002, an increase of 3.4% in costs had to be expected. Therefore the internal control system led to a remarkable decrease in costs for medical goods.

    Laboratory investigations additionally cover roughly 20% of patient-related costs and almost 5% of all university hospital costs [4]. Control of these costs therefore is mandatory but published reports are few:

    The introduction of laboratory profiles for coagulation analysis in the University of Virginia in Charlottesville, USA led to a reduction of laboratory costs by $ 20,000 per year [10].

    The implementation of a laboratory budget and its surveillance in the Pegasus Medical Group in Christchurch, New Zealand led to a reduction by 22.7% [11].

    A cost control program in the surgical unit of Cornell University in New York, USA, led to a reduction of costs for laboratory investigations by 26–28% [12].

    The information about the costs of laboratory investigations in children with diarrhea at the Children's Memorial Hospital, in Chicago, USA, led to a reduction of 43% [13].

    The reduction of laboratory costs by 33.5% from 2002 to 2003 in our study again confirms the effective cost control in patient-related costs by a continuous system of internal control.

    Thirty-day mortality is the most reported factor to display overall quality of medical treatment in cardiac surgery although numerous factors have an impact on this. As shown by the course of 30-day mortality overall, and in CABG surgery, the measures of cost control did not reduce quality of medical treatment in total.

    4.2. Satisfaction of cooperating cardiologists

    The term ‘customer’ frequently appears strange to members of the healthcare system [14] since they usually do not feel as service providers. It is defined as an

    ‘organization or person that receives a product (includingresults of a process)’ [5]

    Every clinical department has to define the most relevant groups of customers, identify their requirements and control their satisfaction actively.

    Besides the patients, one of the most important groups of customers is represented by the cooperating hospitals and physicians. Although the cooperation with hospitals is most important, an evaluation of physicians focussing on existing cooperations resulted in only 25% satisfaction [15]. Frequently physicians demand improved communication. In an analysis of a Berlin children's hospital with pediatricians [6], a high degree of their satisfaction with the communication was shown; numerous approaches for the improvement were identified but unfortunately no data for the analysis after the modification of processes were reported.

    The increased satisfaction with accessibility and communication in our study has proven the possibility of improvement by modification of structures and processes guided by repeated evaluations.

    In summary, a process based QMS according to ISO 9001, with its streamlining of intern processes, results in improved cost containment and improved satisfaction of external partners without loss in quality of medical treatment.

    Appendix A. ICVTS on-line discussion

    Author: Ludwig K. von Segesser (CHUV, Lausanne, Switzerland)

    eComment: The authors should be congratulated for their success in cost containment and customer satisfaction by a quality management system based on EN ISO 9001:2000 standards. However, the approach selected is not exactly free of charge, and requires also a lot of effort in planning, implementation and follow-up. As a matter of fact, quality management in accordance to EN ISO 9001:2000 standards is never complete but rather an on-going program. Therefore, it would be interesting to know: (a) how many resources were invested in this project; (b) how it was financed; (c) how the recurring charges will be handled.

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