Completeness of informed consent in supporting national standard accreditation of patient and family rights 5 hospitals at Ropanasuri surgical special hospital in Padang

INTRODUCTION

Ropanasuri Surgical Special Hospital is a hospital that consists of several surgical services including orthopedic, oncology, urology, digestive, medical rehabilitation and chemotherapy services. Based on the specifics of surgery at this hospital, it is necessary to analyze the completeness of the files, especially the informed consent files needed for each surgical procedure.

Informed consent is an agreement or patient’s approval for medical efforts that will be carried out by the doctor against him, after the patient gets information from the doctor about medical efforts that can be done to help him accompanied by information about all possible risks.²

Completeness of informed consent is needed to support accreditation of national standards for hospital accreditation through patient and family rights (PFR) Assessment Standard 5 Director-General of Health Ministry of Health of the Republic of Indonesia NO. HK.00.06. 3.5 00788 about the combined hospital accreditation commission.³ In this study, researchers took data at a specialized surgical hospital and researchers observed all the completeness of informed consent in each surgery such as orthopedic services, oncology, urology, digestive, medical rehabilitation and chemotherapy services.

Informed consent is needed to support accreditation of national hospital accreditation standards through PFR Assessment Standards 5 Accreditation is the process of assessing the extent to which hospitals have implemented standards where accreditation is an acknowledgment from the government given to hospitals that meet the standards set by the Director-General YanMed Depkes RI NO. HK.00.06. 3.5 00788 about the combined hospital accreditation commission.² In this study, researchers took data at a specialized surgical hospital and researchers observed all the completeness of informed consent in each surgery such as orthopedic services, oncology, urology, digestive, medical rehabilitation and chemotherapy services.

Based on the description above it can be seen that the purpose of this study is to analyze and find out the complete picture of informed consent of the surgical procedure in supporting the accreditation of National Standards for PFR 5 hospital in Ropanasuri Hospital, Padang. Accuracy in filling informed consent can affect the quality of medical record files which has implications for improving the quality of service and hospital accreditation.

METHODS

This research was conducted at Ropanasuri Surgical Special Hospital, West Sumatra from February to August 2019. This study used was a descriptive method with a qualitative approach. The population is the overall object of research.³ The population used was the entire surgical patient medical record file in 2018, namely 3,093 medical record files. The sample is part of the population that can be considered to represent and reflect the state of the population. This sampling procedure is random sampling. Sampling was carried out using a formula according to Notoatmodjo and 355 medical records were obtained.¹ The data collection technique used is the observation method that is direct observation of the medical record file and direct interview to the medical record officer. Data processing was done using Microsoft Excel computer programs.

RESULTS

Comprehensive analysis of informed consent

Based on the Table 1 about filling in patient identification in the informed consent form at Ropanasuri Surgical Hospital in 2018, it is known that all data on the patient’s identity are 100% completely filled.

Based on Table 2 it can be seen that for filling the patient's family identity (the approver) for the name of the approver, age, sex, complete address with a percentage of 99.43% and only 0.56% incompleteness on each item. On the item approval date there are 3 files that are not filled in with a percentage of 0.85%.

Based on Table 3, it can be seen that for filling the identity of the doctor who gave the action, it was completed, 353 with a percentage of 99.44%. Whereas for information providers there are 9 incomplete files with a percentage of 2.54%.

Based on Table 4 it can be seen that the percentage for completeness of the type of action is 99.71% complete.

Based on the Table 5, it can be seen that the highest percentage is filled in the diagnosis of well differentiated (WD), dedifferentiated (DD), medical measures and goals is 99.71%. In addition, it can also be seen that for the overall data filling type of information the percentage of completeness of the filling is above 90% and it can be interpreted that the data filling in the type of information at the Ropanasuri surgical special hospital in Padang is very good.

Based on Table 6 it can be seen that for the highest percentage filled with complete data on the doctor’s name items, the doctor’s signature and the patient/guardian’s signature is 99.71%. Whereas for the witness’ signature there were 10 files with a percentage of 2.81% which were not signed by the witness.

To support quality health services and produce precise and accurate information, of course, it must be supported by the completeness of data on each medical record form and the informed consent form. If the form is not filled out completely, it will cause the information contained in the medical record to be inaccurate and inaccurate and the quality of the medical record will decline.⁴ Herfiyenti had previously conducted research on this informed consent but observed in JCI PFR Standard 6 and obtained the results of the greatest incompleteness found in filling in the informed consent item for a prognosis explanation of 54.1%, alternative and risk of 52.5% and complications of 50.8%.⁴

DISCUSSION

The biggest incompleteness in filling the signature item approval information was 2.81%, the information provided in the completeness section for filling in the doctor's identity was 2.54%, and the voter’s name 1.70% in filling the authentication. The results showed that the completeness of the informed consent in Ropanasuri surgical specialty hospitals was very good based on the percentage of the informed consent sheets that were filled in with a percentage of 83.38% and 16.62% incomplete informed consent sheets. More than half of the approval information sheets were filled in completely. Research on informed consent was previously carried out by Aisyah, about the factors that caused the incompleteness of filling out an informed consent sheet for eye surgery at the eye hospital Dr. YAP Yogyakarta and obtained 95 sheets of complete informed consent with a percentage of 38.13%, 49 sheets incomplete with a percentage of 19.41% and 107 sheets not filled with a percentage of 42.43% of the 251 files developed.⁶ Based on interviews and observations of factors causing incompleteness in human resources, namely doctors and nurses. Most of the doctors who were operating visited doctors, doctors who relied on nurses, lower awareness of doctors to complete, less activity of nurses to complete, improved nurse communication with doctors.

Informed consent is interpreted in the legal tradition as grounded in and justified by the moral principle of respect for autonomy. However, in the legal context, informed consent is not precisely about how best to respect autonomy or to enable autonomous decision making. Legal language is oriented more toward specific (correlative) rights and duties that are derived from principles than towards the principles themselves. Thus, in case law the justification for informed consent is couched in rights language the patient's right to self-determination and the primary concern of the law is to prescribe the duties that devolve upon physicians so that this right be protected.⁷

Completeness of medical record documents greatly affects the quality of medical records. Incomplete documents cause the coder to not be able to determine the information needed in determining the diagnosis code and medical procedures correctly. The size of the tariff that appears in the INA CBGs software is determined by diagnosis codes and medical procedures. Wrong writing of diagnoses and medical procedures will affect the financing rates that have an impact on hospital revenue.⁸ According to Permenkes RI No. 129 of 2008 that a complete medical record is a medical record that has been filled out in less than 24 hours after outpatient services or after inpatients are allowed to go home with a 100% filling standard.⁹

Explanation regarding informed consent that must contain a diagnosis, procedure for medical treatment, the purpose of medical treatment, alternative other actions and risks, risks and complications that may occur along with the prognosis have been contained in Law No. 29 of 2004.¹⁰ It was also explained in the Republic of Indonesia Minister of Health Regulation no. 290/MENKES/PER/III/2008 article 7 paragraph 3 which outlines the actions of medicine at least covering the diagnosis and procedure of medical action, the purpose of the medical action taken, alternative other actions and risks, risks and complications that may occur, the prognosis for the action conducted and estimated financing.¹¹

Completed informed consent helps support accreditation of national hospital accreditation standards because it is found in the PFR 5 standard for namely in PFR 5.2 and PFR 5.3. In this study, researchers observed all standards ranging from PFR 5.1 to PPA 5.3 to add information relating to the completeness of the medical record file and because it was incorporated in the power purchase agreement (PPA) standard 5. PPA standard 5 explains the existence of regulations regarding general agreement and documentation in the medical record. Patients outside the action that requires separate informed consent. General consent is requested when the patient is first admitted to the outpatient or every admission. The patient and/or family are asked to read, then sign the general consent.⁵ In this study, the results obtained that for filling the patient's identity filled completely, that is 100%, this is in line with the Republic of Indonesia Ministerial Regulation No. 129 of 2008 that a complete medical record is a medical record that has been filled out in less than 24 hours after outpatient services or after inpatients are allowed to go home with a 100% filling standard.

CONCLUSION

296 pieces of informed consent were filled in with a percentage of 83.38%, 59 sheets of informed consent were incomplete with a percentage of 16.62%. The greatest incompleteness found in filling the informed consent items of witness signatures of 2.81%, providing information on the completeness of filling the doctor's identity by 2.54% and the name of the witness 1.70% on filling the authentication.

ACKNOWLEDGEMENTS

The author thanks the Directorate of Research and Community Service, the Directorate General of Research and Development Strengthening, Ministry of Research, Technology and Higher Education, Indonesia. The author thanks the Director of the Padang Ropanasuri Special Surgery Hospital Dr. Thomas Darwin and medical record officers. The author would like to thank Fairuz Tridania Anum, Maisyarah, and Ridwan Alfa Rizi as the data collection team in the field.

Funding: The study was funded by the Directorate of Research and Community Service, the Directorate General of Research and Technology Strengthening, Ministry of Research, Technology and Higher Education, Indonesia Fiscal Year 2019

Conflict of interest: None declared

Ethical approval: The study was approved by the Institutional Ethics Committee

REFERENCES

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