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SUMMARY

EVALUATION OF SERVICE PERFORMANCE IN IGD RSUD PRAYA LOMBOK TENGAH AFTER APPLYING QUALITY MANAGEMENT SYSTEM OF ISO 9001 CERTIFICATION

I Ketut Sudarsana 09/308520/PKU/11783

POST GRADUATE PROGRAM OF GADJAH MADA UNIVERSITY MEDICINE FACULTY JOGJAKARTA 2011

EVALUATION OF SERVICE PERFORMANCE IN IGD RSUD PRAYA LOMBOK TENGAH AFTER APPLYING QUALITY MANAGEMENT SYSTEM OF ISO 9001 CERTIFICATION

Filed by I Ketut Sudarsana 09/308520/PKU/11783

Has been approved by

Supervisory I

Supervisory II

Dr.C.Tjahjono Koentjoro,MPH Dr.PH Date: Sept 2011

Ir.Valentina Dwi Yuli S, M.Kes Date: Sept 2011

ABSTRACT

Background: Anticipating the operationalization of new airport in Lombok Tengah province, in 2009 IGD RSUD Praya has been awarded ISO 9001:2000 certificate as a result of some efforts to improve its quality. However, in the last 4 years there have been increasing number of patients in RSUD Praya with some complaints of IGD services, the result of patients satisfaction survey in IGD RSUD Praya which has not been reaching the expected target, and there has not yet been any evaluation to the service performance improvement after applying ISO 9001:2000 certification. Objective: Evaluating service performance in IGD RSUD Praya Lombok Tengah Province after employing quality management system of ISO 9001:2000 as well as finding out the causes of performance changes in IGD RSUD Praya in accordance to articles in ISO 9001:2000. Method: The design of this study is explanatory case study with special holistic single case design to evaluate service performance in IGD RSUD Praya after applying quality management system of ISO 9001:2000. Analysis and Result: Respond time service performance, IGD staff competency, and medical record completeness tend to improve matched by the result of evaluation of applying ISO IGD RSUD in article 4, 5, 6, 7, and 8 of ISO 9001:2000 which findings from previous audit didnt appear in the next audit. While the patient satisfaction to the service performance has not reached the expected target as its stated in ISO. This is supported by the result of interview stressing on the need to do survey toward patients need and want in IGD RSUD Praya, and to evaluate optimally the result of satisfaction survey, complaint, critics, and suggestion from Patients in IGD RSUD Praya. Conclusion and Suggestion: There were different service performance in IGD RSUD Praya between pre and post application of quality management system of ISO 9001:2000 in which the service performance in IGD RSUD Praya tend to improve, yet patients satisfaction of service performance in IGD RSUD Praya was below the expected target stated in ISO. It is suggested that the application of ISO 9001:2000 should be conducted and evaluated continually. Keywords: Evaluation, Quality Management System of ISO, Performance Service in IGD.

INTRODUCTION

The hospital is an organization engaged in health services and as a referral center below the level of service, the hospital needs to improve the quality of service to people in need and can provide quality service with quality. Quality management system to support the micro-system service to work optimally so as to meet the needs, expectations, and values of customers.1 In the ISO 9001:2000 quality management system has been revised to ISO 9001:2008 quality management system is based on the quality management system and process model approach consists of five elements or elements of the essential requirements of the quality management system, management responsibility, resource management, the realization products, as well as measurement, analysis and improvement where there is a measurement of patient satisfaction in order to be eligible customers.2 ISO quality management standards for assessing hospital

performance using standardized quality system compared with the assessment of function and purpose of the hospital, where there are 12 performance indicators as an instrument to measure the performance of hospitals that must be taken to be a source of information for community.3 Praya Hospital as a hospital grade C of the Government of Central Lombok regency, with a capacity of 147 beds TT, is the only governmentowned hospitals in NTB who already have the ISO 9001:2000 quality standard of service to the Council obtained ISO 9001:2000 certification in May 2009 from the Quality Assurance throughout the world, to anticipate the operation of the New Lombok International Airport is located in Central Lombok regency, and the efforts hospitals Praya, Central Lombok to win the competition in improving the quality of the product or service that meets customer and appropriate regulations.2

ISO 9001:2000 certification assessment area hospital emergency room Praya, Central Lombok by the number of employees as many as 33 people, consisting of 6 doctors, nursing staff 22 people,4 people porter personnel, and administrative staff person, but before the implementation of ISO 9001: 2000 IGD Praya Hospital has been accredited 5 service, one of the emergency services in 2006 but until now has not done the evaluation of the performance improvement of hospital services. In implementing the ISO 9001:2000 IGD Hospital Praya, Central Lombok have to set quality objectives as set out in clause 5.4.1 of ISO 9001:2000.4 Quality Objectives are established, among others : The response time of ER patients, ER patients waiting times further for the management, the incompleteness of the charging status of patients with ER, the ER staff competence, and patient satisfaction. Quality objectives is an indicator that should be measured to determine whether the Hospital ER Praya, Central Lombok can achieve what purpose. Based on data from the fields of development and quality control services Praya Hospital (2010), there are still complaints from patients and the introduction of Praya Hospital emergency room services, both in facilities, comfort, cleanliness, and staff skills.Patient satisfaction survey results at Praya Hospital ER ever do not ever reach their intended target, and results of RAP-Home I (2006) and II (2008) regarding the SPM measurement indicators in a hospital emergency department found the results of the response time of 2, 25 minutes and 13.05 minutes, and the competence of ER to 29% of doctors and nurses 71%. In the implementation of quality management ISO 9001:2000, IGD Hospital Praya, Central Lombok began certification in May 2009 has been conducting internal audits four times, followed by four times the management review, and 2 times the external audit in February 2010 in January 2011, but until now This has never been an evaluation of performance enhancement services at the Hospital ER Praya.5

RESEARCH METHODS

Evaluation is an activity to assess, measure, or compare what has been done and achieved with what must be achieved and implemented.6 The study design will be used is a case study explanatori a holistic single case design, to evaluate the service performance Praya Hospital emergency room after the certification of ISO 9001:2000 quality management. This design was chosen because of the problem under study is a contemporary problem with multiple sources of data and researchers are not there to control the events under study.7 The research was conducted in a hospital Praya Road. HLHasyim Praya, Central Lombok which is the C-class hospital that is owned by the government of Central Lombok district, and the only government-owned hospitals in NTB who have obtained the certificate ISO 9001:2000. In this study collected primary data in the form of quantitative data on patient satisfaction to the emergency services, response time of emergency patient handling, competency IGD, the completeness of filling the ER medical records, as well as the suitability of the implementation of ISO 9001:2000. Patient or the introduction of 100 people who were given a questionnaire relating to patient service satisfaction Praya Hospital emergency room, while emergency room doctors and nurses involved before and after ISO certification as much as 2 person interviews were conducted to determine changes in the pattern of performance before and after ISO 9001:2000 certification. Interview form of open questions with interview guidelines, observation of emergency room patients and medical records to determine the response time Praya Hospital emergency room services started coming up to the patient's physician was calculated and recorded the time, making the percentage of emergency room service response time < 5 minutes. Check the list and form filling completeness of patient records Praya Hospital emergency room by looking at the

completeness of medical records to fill the relevant forms required ER medical records are used, the percentage of patients who complete IGD makes the filling of medical records. Chek conformance clause of ISO 9001:2000 list is used to determine the suitability of the implementation of ISO in hospital emergency rooms Praya to see articles 4, 5, 6, 7, 8 ISO 9001:2000 is required, using the guidelines of ISO clause examination of the suitability list. As for knowing the competency of trained personnel in the emergency room doctors and nurses who have done and have a certificate of competency required to use data Praya Hospital personnel. Secondary data in the form of reports or documents concerning the service performance Praya Hospital emergency room patient satisfaction, response time, personnel competence, and completeness of medical records prior to the implementation of ISO 9001:2000 IGD in 2008 and after the implementation of ISO 9001:2000 in 2009, the year 2010. All data both primary data and secondary data obtained and carried out data processing and continued with the presentation of data.

RESULTS AND DISCUSSION

1.ER patient satisfaction service performance Praya From the research results of service performance satisfaction ER patient satisfaction results obtained with 82.4% of patients, with the number of male respondents than female respondents are more numerous and the largest age group is between 41-50 years. The result is still above the minimum service standards for emergency > 70%,8 but still below the standard of hospital performance indicators by 90%,3 and is still below the target achievement of the ISO quality by 85%. Judging from the achievement of the ISO quality Praya Hospital emergency room on service performance declined from the previous ER patient satisfaction by 84% in March 2011, probably due to the understanding and needs of patients

keiinginan Praya Hospital emergency room, this can be seen from the findings of conformance clause of ISO 9001 using an instrument assessment of an organization's quality management system of clause 4, article 5, article 6, article 7, and paragraph 8 of ISO 9001:2000 with ISO management representative and head of Praya Hospital ER IGD chief Praya Hospital, but does not involve the management and support units Praya Hospital emergency room, where the differences seen in verse 5 Management responsibility has not been set of customer needs and desires are good, according to the guidelines,9 the importance of communicating customer requirements and legislation Act, and clause 7 Product realization that not make the most of their communication with customers by looking at the complaints of customers such as the use of suggestion boxes, impressions and user messages, such as guidelines,9 of article 7 of the customer communication in which an organization must establish and implement effective arrangements to communicate with customers about the customer feedback, including customer complaints, and according to,10 that service quality is a little hard to measure because it generally is subjective because it involves patient satisfaction, it depends on perception, background, socioeconomic, norms, education, culture, personality and even It depends on perception, background,

socioeconomic, norms, education, culture, and even personality. Prior to obtaining certification of ISO 9001 Implementation of patient satisfaction with the performance of 60% increase in pre-certification to ISO 9001 certification in May 2009 by 70%, probably due to the time at which the previous certification preparation IGD Praya Hospital has also undergone accreditation and RAP-Home, but in research These researchers did not identify the impact of accreditation and RAP-Home. Where by,11 revealed significant improvement in patient satisfaction in the emergency room after the intervention and the nurse patient

communication.

In the present study did not measure the external customer satisfaction is employee Praya Hospital emergency room, where in the opinion of,10 quality-oriented health services both internal and external customers.

2. Service response time performance Praya Hospital ER In this study conducted with the patient's medical record the observation of emergency room Praya Hospital, regardless of the classification of emergency room patients, such as emergency care guidelines,12 which classifies patients with emergency, no emergency room patients, emergency patients are not life threatening, no patients emergency department did not use observations form the medical records of emergency room response time Praya Hospital, obtained the results of 91%, judging from the achievement of quality objectives of ISO Praya Hospital ER on the ER performance of the service response time has increased compared with the previous March 2011 by 87% , and above target at 85% ISO quality might be due to the understanding and implementation of the ER response time communications, this can be seen also from the results of ISO conformance clause, although the differences are found clause 4 of the quality management system requirements, where not all employees know IGD IGD operational processes and management responsibility clause 5, where not all ER personnel to get the quality policy of socialization, is due to new employees in the ER so it is necessary to perform additional socialization for the understanding of the ISO and operational processes Praya Hospital emergency room, but in the resource management section 6 and subsection 8 Measurement, analysis, improvement has been correspond with reality. This is in accordance with the opinion,13 paragraph 8 Measurement, analysis, and improvement in which organizations must plan and execute the process of measuring, monitoring, analysis and

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improvement is needed in order to ensure conformity of the quality management system. Before the implementation of ISO 9001 to obtain the response time performance with 70% rise in pre-certification to ISO 9001 certification in May 2009 by 80%, probably due to the time at which the previous certification preparation IGD Praya Hospital also experiencing

accreditation and RAP-Home. Although pre-certification audit findings in paragraph 4 where the quality management system requirements have not been up to understand the quality policy is applied so that the necessary understanding of the quality policy of the Hospital emergency room Praya socialization. Figures Praya Hospital ER response time of 3.9 minutes is obtained, is the proper guidelines,14 to 858 Kepmenkes / Menkes / SK / IX / 2009 on standard hospital emergency room, where emergency room patients should be treated no later than 5 (five ) minutes after the ER.

3. competence of service performance Praya Hospital ER In this study physicians obtained Praya Hospital emergency room a number of 6 people (100%) have had training and certification needed to work in the ER, whereas ER nurse about 22 people (82%) have training and have the necessary certificates, so that the results obtained from 91%, the result is still above the standards of hospital performance indicators by 50%,3 and is above the target of achieving ISO quality objectives set at 90%, but still below the minimum standards of emergency services 100%.8 In terms of achieving IGD Praya ISO quality is still the same hospital from the previous March 2011 for 91%, this is because in the span of time is not been to the addition of Praya Hospital emergency room nurse who had attended the training needed to meet both personal competence and assistance to management, it This can be seen also conformance clause 6 Resource management in accordance with reality, accordance with the guidelines,9 section 6 in human resources, where the personnel performing

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work affecting product quality must be competent on the basis of education, training, skills and experience. Before obtaining ISO 9001 certification authority Competence IGD implementation performance by 50% rise in pre-certification to ISO 9001 certification in May 2009 was 77%, probably due to the time at which the previous certification preparation IGD Praya Hospital has also undergone accreditation and RAP-Home, as well as before certification of all general practitioners on duty at the hospital Praya was given a job as a doctor in the emergency room Praya Hospital, but before certification of the ISO has designated only six general practitioners who have the competence requirements of duty in the ER, is in accordance with the guidelines,14 through Kepmenkes 858 / Menkes / SK / IX / 2009 standard hospital emergency room, where general practitioners should receive emergency training GELTS, ATLS, ACLS, and nurses trained in emergency nursing BTLS, BCLS.

4.Completeness of medical record service performance Praya Hospital ER This study obtained the medical records IGD is a complete fill 92%, the result is still below the standard of hospital performance indicators by 95%,3 but still above the achievement of the ISO quality objectives set at 85%, and earlier than in March 2011 increased by 90%, it This can be seen the absence of findings regarding the completeness of medical record in paragraph 4 of the quality management system requirements, in the opinion,13 and guidelines,9 where the organization should establish, document, implement, and maintain a quality management system ISO 9001:2000 and continually improve effectiveness in accordance with the requirements of paragraph 7 of standards and realization of products, such as opinions,13 and guidelines,9 which organizations must plan and develop the processes needed for product realization, planning of product realization shall be consistent with the requirements of other processes of the quality management system.

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Before the implementation of ISO 9001 performance of the completeness of medical records obtained by the ER 65% increase in precertification to ISO 9001 certification in May 2009 by 70%, probably caused during the preparation for ISO certification, which previously IGD Praya Hospital also experiencing accreditation and RAP-Home, but in this study researchers did not identify the impact of accreditation and RAPHome, as well as the views of the audit findings pre sertfikasi clause 7 Product realization of the medical records that must be ensured that a complete fill after repair did not reappear later audited.

5. Trend of changes in service performance Praya Hospital ER Results Praya Hospital emergency room service performance before and after application of ISO 9001:2000 is displayed in the form of an image to see the trend of changes in performance post-implementation services ISO 9001:2000 quality management system, in accordance with the opinion,15 which monitors the activity of the development trend in activity in several years can be seen on the graph by comparing against established standards. In this study measures the performance of personnel competence, response time, completeness of medical records, patient satisfaction, without a measure of financial performance because it has not been specified in the ISO quality objectives Praya Hospital emergency as performance goals and objectives Praya Hospital emergency services. From the results of the evaluation of the implementation of ISO's Hospital emergency room to see Praya in accordance with ISO 9001:2000 clause in the audit prior to certification, certification, until after the certification audit findings, there are still improvements to be carried out, followed in the management review to evaluate the improvement and implementation of target , where the findings in previous audit findings are not repeated in subsequent audit that shows the quality management system performed consistently, such as guidelines,9 which clause 4 of the

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quality management system requirements, where the processes for quality management system includes processes for management activities, provision of resources , product realization and measurement, and appropriate consultation,6 where the suit is the fulfillment of the requirements or criteria, or a condition within the tolerance limits or requirements established criteria, where the suitability of the quality management system compared to the standard ISO 9001:2000. After achieving ISO certification obtained ISO quality Praya Hospital emergency room in the ER changes in patient satisfaction performance improvement is less significant results obtained, most likely will remain, although the performance of patient satisfaction is still above the target ISO quality targets, but after the target increased to 85% quality performance results Praya Hospital ER patient satisfaction has not reached its intended target, this may be due to a lack of understanding of the needs and desires of emergency room patients, according to the results of interviews indicate that the survey will be added to the wishes and needs of emergency Praya Hospital patient satisfaction

questionnaires as a complement to the room existing patients, and the findings of the survey maximum, both from complaints, feedback, and suggestions from patients Praya Hospital emergency department, and need to be addressed in the management review to improve future, this opinion,13 and guidelines,9 clause 8 Measurement, analysis and

improvement, the organization must plan and execute the process measurement, monitoring, analysis and improvement is needed in order to ensure conformity of the quality management system, and according to the findings in paragraph 5 Responsibility management responsibility in which the provision has not been keiinginan customer needs and good, and clause 7 Product realization where communication with customers that have not performed optimally, but the results of the study,16 revealed the perception of quality of service to the patient and family satisfaction with Servqual attributes do not all have a positive correlation.

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Changes in the performance of services which tend to increase the response time, this might be due to the understanding and communication of nurses and doctors who attended Praya Hospital emergency room, according to an interview that emphasizes cooperation and communication between doctors and nurses who know and understand and responsive in responding to every patient who came to the emergency room Praya Hospital, as well as findings regarding response time, both in Clause 4 of the quality management system requirements, management responsibility, paragraph 5, article 8 Measurement, analysis, improvement, does not appear in a subsequent audit that shows the quality management system implemented consistent, where according to,17 in his research stated adherence to the response time identified beneficial for survival, and reduce the severity of the disease. Changes in the competence of service performance remains but the phase tends to increase, this is because there is a phase in which the absence of additional staff both doctors and emergency room nurse who has been trained to the competencies required to work in the ER both personal fulfillment and management assistance Praya Hospital , as well as improved performance due to the addition of ER personnel who have done the necessary training and competence of staff turnover has not been competent IGD IGD with personnel who already have the competencies required to work in the ER Praya Hospital, consistent with the interview, stressing that the doctors and nurses on duty in the ER Praya Hospital must have the competencies needed by way of personal fulfillment and to help the hospital management, as well as findings regarding the fulfillment of the competence of workers, both in Clause 4 of the quality management system requirements , paragraph 5 Management responsibility, Resource management section 6, in accordance with that opinion,13 and guidelines,9 which organizations must apply and provide necessary resources to properly implement and maintain QMS ISO 9001: 2000, as well as personnel performing work affecting product quality must

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be competent on the basis of education, training, skills and experience, where the findings do not appear again showed the quality management system applied consistently audited next. Changes in the completeness of medical record service

performance is likely to increase significantly, this may be due to the habit of doctors and nurses Praya Hospital emergency room, assisted by administrative personnel in completing the medical records of patients' medical records Praya Hospital emergency room, according to the results of this interview, which emphasized in the doctor's habit to complete medical records and emergency room nurse's role in helping to fill the completeness of patient records of emergency room Praya Hospital, and the role of medical records to remind and return the medical records of patients who are not yet complete and periodically provide input to the emergency room Praya Hospital . Audit findings regarding the

completeness of medical records IGD, both in Clause 4 of the quality management system requirements, in accordance with that opinion,13 and guidelines,9 which organizations establish, document, implement, and maintain a quality management system ISO 9001:2000 and continually improve effectiveness in accordance with standard requirements, clause 7 Product realization, clause 8 Measurement, analysis, improvement, does not appear in a subsequent audit that shows the audit results are always followed up and discussed in management review, and the quality management system is implemented consistently. From interviews to see the cause of emergency room services Praya Hospital which is generally perceived performance tended to increase after the implementation of quality management system ISO 9001:2000, felt after the implementation of ISO, IGD Praya Hospital may work regularly use established standards to achieve the objectives to be achieved in the ER quality objectives, but the results of the study,18 in which hospitals are implementing ISO 9000 QMS is not all experience

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improved performance, as well as hospitals that implement CQI measures do not all have an impact on hospital performance improvement. Achievement of quality objectives IGD monitored and evaluated through internal audits, management review, external audit, which measures the performance does not automatically provide answers to how well the actual performance of current and alternative fixes do not give to be done and is simply a beginning point for further analysis,19 Changes in service performance Praya Hospital emergency rooms as well as causing changes when viewed with the clauses of ISO through interviews and checklists of compliance clauses of ISO 9001:2000, as in the study,20 in which the ISO 9001:2000 quality management system can be used as an indicator of performance by using ISO 9000 clause 4:20, conducted in accordance with established standards and continuously evaluated for improvement in order to improve the quality of services provided, and in accordance with the guidelines,9 that the organization that successfully manages to systematically and transparently to determine the process that leads to improved organizational performance and customer-oriented, and uses the principles of the eight quality management, the organization will move toward improved performance.

CONCLUSION

From the results of research and discussion, and refer back to the formulation of research questions and problems, it can be summed up as follows: 1. There is a difference in the performance of emergency room services Praya Hospital after the application of ISO 9001:2000 quality management system is seen from changes in the emergency room service Praya Hospital performance before and after implementation of quality management system ISO

9001:2000.

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2. Trend change in the performance of emergency services Praya Hospital in general tend to increase after the certification of ISO 9001:2000 quality management system, but the performance of emergency services Praya Hospital rooms of patients satisfaction improvement has not reached the targets set in the ISO quality objectives. 3. Changes in the performance of medical record completeness IGD is quite dominant in the post sertfikasi ISO 9001:2000 seen from the results change Praya Hospital emergency service performance and conformance clause of ISO 9001:2000.

SUGGESTION

1.For Praya Hospital: a. Implementation of ISO 9001 quality management system should be implemented and evaluated consistently in order to improve service performance Praya Hospital emergency room. b. Applying ISO 9001 quality management in other units in order to improve the environmental performance of hospital services Praya Hospital as a whole. c. Praya Hospital Management continues to implement ISO

9001:2000 quality management system has been updated with the ISO 9001: 2008 with the proposed budget. 2.For further research: Can be used a reference for future studies to better reduce the flaws in this study that categorizes the response time in the triage criteria, to evaluate the service performance of internal customer satisfaction / employee IGD IGD financial performance and service, and involve the relevant units / IGD support.

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BIBLIOGRAPHY

1. Koentjoro, T. (2007). Health Regulations in Indonesia (1st ed.). ANDI Yogyakarta. 2. AIMS. (2006). ISO 9001:2000 Training Giidelines Praya Hospital. AIMS Consultants, Surabaya 3. Depkes. (2005). Hospital Performance Indikator. Direktorate General of Medical Services, RI Ministry of Health. 4. WQA. (2009). ISO 9001:2000 Audit Guidelines Praya Hospital. WQA-Sea Jakarta. 5. ISO, (2010). ISO Data Hospital Praya 2010. Regional General Hospital Praya Central Lombok.. 6. Susilo, W. (2003). Internal VORQISTATAMA BINAMEGA. Quality Audit (1st ed.). PT.

7. Yin, R. (2011). Design Case Study Method (10th ed.). PT RajaGrafindo Persada, Jakarta. 8. Depkes. (2008). Minimum Service Standards. Directorate General of Medical Services, RI Department of Health. 9. BSN, (2006). Quality Management Systems - Guidelines for Performance Improvements. National Standardization Agency, Jakarta 10. Wijono, J. (1999). Health Care Quality Management Theory and Application Strategies (1st ed.). Airlangga University Press, Surabaya. 11. Taylor, D., Kennedy, M. P., Virtue, E., & Mcdonald, G. (2006). A multifaceted intervention improves patient satisfaction and perceptions of emergency department care. Access, 18(3), 238245. 12. Depkes, (1992). Guidelines for Emergency Services. Directorate General of Medical Services, RI Ministry of Health. 13. Gaspersz, V. (2003). ISO 9001:2000 and Continual Quality Improvement (3rd ed.). PT Gramedia Pustaka Utama, Jakarta. 14. Menkes, (2009). Ministerial Decree Indonesia Republik 856/Menkes/SK/IX/2009 on Standards of Hospital ER. Jakarta.

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15. Soejadi, (1996). Efficiency of Hospital Management. KATIGA BINA, Jakarta. 16. Suryadi, Y. (1998). The Relationship between Perceptions of Quality and Service Satisfaction or Recogniton of Patients at Hospital ER Ponorogo. 17. Pons, T , Haukoos, J , Bludworth, W, (2005). Paramedic Response Time: Does It Affect Patient Survival?, doi:10.1197. 18. Berg, M & De Mul (2007). Completeness of medical records in emergency trauma care and an IT-based strategy for improvement, 32(2), 157-167. 19. Maharani, C. (2007). Evaluation of CQI in Hospitals to Implement ISO 9000 Quality Management System in Indonesia. 20. Wibisono, D. (2006). Performance Management Design Concepts and Techniques Improve Competitiveness (1st ed.). Erlangga Jakarta. 21. Koning, L., Hospital, R. C., & Berg, M. (2005). An ISO 9001 quality management system in a hospital. International Journal of Health Care Quality Assurance, 18(5), 361-369. doi: 10.1108 / 09526860510612216.