INSTITUTIONAL POLICIES
CONTENT
A. Quality Policy and Continuous Improvement.
B. Risk Management and Administration Policy.
E. Service Humanization Policy
F. Social and Environmental Responsibility Policy
G. Human Talent Management and Cultural Transformation Policy
H. Technology Management Policy
I. Teaching-Service Relationship Policy
L. Information and Communications Management Policy
N. Occupational Health and Safety Policy
P. Conflict of Interest Policy
Q. Quality Control Policy
R. Licensing Policy
S. Labor Disconnection Policy
12. BIBLIOGRAPHICAL REFERENCE 285
13. TRACEABILITY OF CHANGES TO THE DOCUMENT. 25
1. MACROPROCESS
Managerial.
2. PROCESS / SERVICE / AREA.
Strategic management.
3. SCOPE
This document defines the institutional policies to comply with the regulatory framework that regulates health management, institutional guidelines and applicable technical standards. The guidelines defined in this document apply to all clinic personnel regardless of their mode of employment, this includes independent professionals who care for patients within the clinic. Institutional policies are reviewed on an annual basis.
4. GENERAL OBJECTIVE
Provide guidelines to facilitate the formulation of the institutional Policies of the Astorga Oncology Clinic, taking into account current regulations, applicable technical guidelines and alignment with Strategic Planning.
5. SPECIFIC OBJECTIVES
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Define the internal guidelines and those responsible for the structuring of institutional policies.
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Define the criteria to characterize the policies in the clinic, in such a way that they are properly structured to facilitate their effective implementation.
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Keep institutional policies updated and compiled in a reference document.
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Facilitate its implementation and measurement of adherence with the clear definition of its quantification method.
6. LEGAL AND REGULATORY FRAMEWORK
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ISO 9001:2015 standard.
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Resolution 3100 of 2019.
7. DEFINITIONS AND TERMS
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Politics1: it is an activity ideologically oriented to the decision-making of a group to achieve certain objectives.
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Strategic Planning1: is the elaboration, development and implementation of different operational plans by companies or organizations, with the intention of achieving objectives and goals set. These plans can be short, medium or long term.
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Management System1: is a set of rules and principles related to each other in an orderly manner, to contribute to the management of general or specific processes of an organization. It makes it possible to establish a policy, objectives and achieve these objectives.
8. THEORETICAL FRAMEWORK
An institutional policy is a written decision that is established as a guide, for the members of an organization, on the limits within which they can operate in different matters. That is, it provides a logical and consistent framework for action. In this way it is avoided that the Management has to decide on routine issues over and over again in deterioration of efficiency. Institutional policies affect all members of an organization.
All institutional policies must be based on and reflect the values of the organization; also, at the same time, be a cultural reflection of institutional beliefs and philosophy. In other words, the formulation of institutional policies will explicitly state how and why that organization values the people who work there. In addition, they must be completely aligned with Strategic Planning in such a way that their application allows the achievement of the objectives set by Senior Management.
Institutional Policies must be clearly formulated so that they become a tool to consolidate organizational objectives and the quality of services offered to all interested parties. This quality can be visualized through greater efficiency in care and administrative processes, improvement in communication between the different parties interested and involved in the care of the user and his family, an immediate source of guidance and a course of action for the members of the organization, promotion of the empowerment of leaders, administrative and support staff, and effective fulfillment of the purpose of the organization.
A crucial point for the definition and formulation of institutional policies in an organization is to involve all the actors in the process that, in one way or another, may be affected by them. The greater the participation of people, the greater the probability of success for the implementation of the institutional policy. The latter minimizes resistance to change and guarantees that the policy does not become an interference for the performance of functions or a dead letter that does not impact the operation, organizational objectives and the transformation of the culture.
Among the advantages of Institutional Policies are:
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Written policies require managers to think through their courses of action and predetermine what actions will be taken under various circumstances.
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An overview of action is provided for many issues, with only unusual issues requiring senior management attention.
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A framework of action is provided within which the manager can operate freely and with greater autonomy.
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Written policies help ensure equal and equal treatment for all employees.
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Written policies create internal communication security at all levels.
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The policy manual is a source of initial knowledge, fast and clear, to locate new employees in their position.
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Streamlines the decision-making process
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Facilitates decentralization by providing guidelines at intermediate levels.
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Serve as the basis for a constant and effective review.
9. GUIDELINES
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All institutional policies must be approved by the General Management.
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For all institutional policies, their complete characterization must be structured.
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The Institutional Policies Manual with the policies contained therein must be incorporated as part of the Induction process for new collaborators and Reinduction.
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Independent professionals who practice within the clinic must sign a commitment to adhere to institutional policies, especially those directly related to their clinical practice. Within this commitment, the specific activities with which the independent professional is committed must be determined (GES-FR-007 ADHERENCE DECLARATION MODEL
INSTITUTIONAL PROCESSES BY INDEPENDENT PROFESSIONAL).
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Adherence to institutional policies must be measured within the framework defined in their characterization and under the methodology established for this. Independent professionals are part of this measurement and the results will be shared with them periodically, in accordance with the adherence measurement schedule of the critical processes that applies to them.
11. INSTITUTIONAL POLICIES.
For the characterization of Institutional Policies, the following variables must be taken into account:
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Content or Policy Statement.
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Objective or Purpose of the Policy.
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Legal or Regulatory Framework (if applicable).
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Statement of Management commitment to the Policy.
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Responsible for compliance.
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Exceptions to compliance with the policy.
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Measurement of its adherence.
The current Policies of the Astorga Oncology Clinic are listed below:
A. Quality Policy and Continuous Improvement.
Policy Statement.
Comply with the established standards to lead processes in the Oncology area in both adults and children, managing to satisfy the needs of patients, their families and all other actors involved in the patient's pathology, always oriented towards continuous improvement.
Objective or Purpose of the Policy.
Generate commitment and cultural change in front of the management of the continuous improvement of the processes, in such a way that the quality is understood and exercised from the being and not only from the doing and the fulfillment of the norm.
Legal or Regulatory Framework (if applicable).
ISO 9001:2015 standard.
Resolution 3100 of 2019 Registration and Authorization Manual for Health Service Providers.
Statement of Management commitment to the Policy.
Senior Management will allocate all the resources required for continuous institutional improvement and compliance with the policy.
It will provide the means for measuring adherence.
It will guarantee communication to all collaborators and other interested parties, ensuring that this manual and the policies included in it are disclosed through the institution's website.
Responsible for compliance.
This policy applies to all employees of the Astorga Oncology Clinic. For the other interested parties (customers, suppliers, users, control entities, etc.), it must be guaranteed that their actions are related to the guidelines defined in the policy statement.
Exceptions to compliance with the policy.
There are no exceptions to this policy for compliance.
Measurement of Adhesion.
Adherence to the Quality and Continuous Improvement Policy will be done annually in the Review by Management with compliance with the quality objectives defined within the framework of the Management System. Likewise, continuous periodic follow-up will be done through the performance of the processes (management indicators) and the follow-up of the Improvement Requests with effective closures that impact the processes.
B. Risk Management and Administration Policy.
Policy Statement.
Risk management at the Astorga Oncology Clinic is characterized by generating a culture of prevention, promoting risk identification, assessment and control actions in such a way as to minimize the impact on their occurrence in all areas of the organization.
Objective or Purpose of the Policy.
The objective of the Risk Management Policy is to establish the elements, resources and the general framework of action for the comprehensive management of healthcare, administrative and strategic risks, to which the Astorga Oncology Clinic is exposed.
Legal or Regulatory Framework (if applicable).
Statement of Management commitment to the Policy.
The General Management undertakes to:
Participate in the definition of the Risk and Opportunity matrix of the different processes defined in the process map, in addition to the Risk and Hazard Matrix at work, to facilitate their identification and impact.
Define guidelines for the definition of the clinic's care risks throughout the flow of care for users in the AMFE matrix.
Arrange the resources for the fulfillment of the action plans to manage the institutional risks defined as priorities.
Define the methodology for monitoring the adherence of collaborators to the policies.
Responsible for compliance.
It applies to all the processes of the institution and to all the personnel that work in it.
Exceptions to compliance with the policy.
There are no exceptions to this policy for compliance.
Measurement of Adhesion.
Adherence to the Policy is hThis will be done by monitoring the effective impact of the risks defined as priority, measuring their NPR index and their evolution over time after treatment.
C. Service Provision Policy.
Policy Statement.
The health care model of the Astorga Oncology Clinic is characterized by being comprehensive, focused on users who require cancer treatment, respecting their priorities, needs and requirements; To this end, it uses the best available scientific evidence and optimally implements the technology at its disposal and, in order to obtain better clinical effectiveness results, participates in the development of research protocols.
Objective or Purpose of the Policy.
Guarantee access, optimize the use of resources and improve the quality of services provided to users focused on comprehensive care to achieve continuity in care and treatment.
Legal or Regulatory Framework.
Law 1751 of 2015: By means of which the fundamental right to health is regulated and other provisions are issued.
Statement of Management commitment to the Policy. The General Management of the clinic is committed to:
Provide the resources at their disposal to favor the accessibility of users and other actors involved in health care.
Generate strategies aimed at the implementation of comprehensive care networks that allow continuity in care and optimization of time and resources.
Promote actions that promote the continuous improvement of the institution to achieve a better quality of health.
Responsible for compliance.
Applies to all collaborators of the institution, customers and suppliers who participate in the user service process.
Exceptions to compliance with the policy.
There are no exceptions to this policy for compliance.
Measurement of Adhesion.
Compliance with this policy will be verified by monitoring the indicators of opportunity to assign appointments and opportunity in addressing interdependent services that impact the user (surgery, diagnostic and therapeutic aids, hospitalization and emergencies).
D. Patient Safety Policy
Policy Statement.
At the Astorga Oncology Clinic, a permanent commitment to the safety of users and their families is established as an essential strategy for a pleasant and safe environment, having the resources and innovative technological tools for reporting events that allow determining and preventing risks derived from the care process, and promoting through the deployment of scientifically proven methodologies, the adoption of barriers and controls that minimize the possibility of occurrence of adverse events, in a non-punitive environment, of trust, rresponsibility and respect.
Objective or Purpose of the Policy.
Promote a safe environment for patient and family care with the least possible risk.
Legal or Regulatory Framework.
Resolution 3100 of 2019. Manual for Registration and Authorization of Health Service Providers.
National Policy Guidelines for Patient Safety June 2008.
Statement of Management commitment to the Policy.
Management undertakes to provide the necessary resources to facilitate the management of risks related to care from their identification to their impact in order to minimize them or prevent their materialization.
Responsible for compliance.
Applies to all institutional processes and to all collaborators, regardless of their mode of contracting, including independent professionals.
Exceptions to compliance with the policy.
This policy applies to all employees of the Astorga Oncology Clinic, including independent professionals without exception.
Measurement of Adhesion.
The measurement of this policy is done through:
Follow-up of events and incidents related to care and the trend of the indicator.
Adherence to the application of the instructional packages defined by the Ministry of Health.
E. Service Humanization Policy
Policy Statement.
At the Astorga Oncology Clinic, all types of care for people are characterized by respect for life, humane and dignified treatment, with quality and warmth actions that are in accordance with our institutional philosophy and that are the seal that distinguishes our management daily.
Objective or Purpose of the Policy.
Offer human care to the patient and their family framed in a warm, reliable, safe treatment and providing all the information required about their care process that allows them to make informed decisions.
Legal or Regulatory Framework.
Does not apply.
Statement of Management commitment to the Policy. The General Management will define the resources that allow the development of strategies framed in the work in the "Being" of the collaborators with the objective of generating empathic and collaborative behaviors that support user management.
Likewise, seek pleasant and harmonious work environments that promote calm and equitable work.
Responsible for compliance.
Applies to all employees of the Astorga Oncology Clinic.
Exceptions to compliance with the policy.
No exceptions apply to this policy.
Measurement of Adhesion.
It will be measured through the user satisfaction survey.
F. Social and Environmental Responsibility Policy
Policy Statement.
The Astorga Oncology Clinic is committed in all its dimensions to respect human and labor rights, in favor of social well-being and environmental protection to contribute to a fairer and healthier society.
Objective or Purpose of the Policy.
Contribute to the development of people and the community in a sustainable way, generating value through strategies that minimize the environmental impact that the clinic generates.
Legal or Regulatory Framework.
Does not apply.
Statement of Management commitment to the Policy.
Provide the necessary resources to facilitate the development of waste disposal strategies.
Comply with current regulations in relation to wastewater discharges, waste management and others that apply.
Facilitate and promote the implementation of strategies aimed at caring for the environment, such as:
Zero printed papers.
energy saving
I save water.
Responsible management of waste generation.
Responsible for compliance.
Compliance with this policy concerns all personnel associated with the clinic, regardless of their type of connection.
Exceptions to compliance with the policy.
For this policy no exceptions apply.
Measurement of Adhesion.
Monitoring of energy and water consumption.
Monitoring the generation of hospital waste.
Monitoring of recycled waste.
Monitoring of water characterization (when applicable).
G. Human Talent Management and Cultural Transformation Policy
Policy Statement.
The management of human talent at the Astorga Oncology Clinic aims to foStrengthen and develop the skills of the institution's employees, promoting personal and professional development and thus generating cultural transformation.
Objective or Purpose of the Policy.
Direct and empower people's skills through coordinated and team work, in conditions of dignity, safety and respect.
Legal or Regulatory Framework.
ISO 9001:2015 standard.
Statement of Management commitment to the Policy.
Contribute to the strengthening of teamwork within the institution.
Promote continuous training as a way of professional and personal development of employees.
Carry out periodic monitoring of the work environment to detect risks related to work and the work environment that interfere with the quality of life in the institution.
Provide resources to strengthen safe work in the institution.
Responsible for compliance.
Applies to all employees of the institution.
Exceptions to compliance with the policy.
This policy has no exceptions to its compliance.
Measurement of Adhesion.
Measurement of the work environment and improvement plans derived from the analysis of the results.
Monitoring of Occupational Health and Safety indicators.
H. Technology Management Policy
Policy Statement.
The Astorga Oncology Clinic is committed to the rational use of health technology, managing the resources to update it, in addition to the search for better technological options that respond to the needs and expectations of our users and collaborators.
Objective or Purpose of the Policy.
Improves patient care through an adequate biomedical technology management process and support for attention seeking a staff trained in its use and having adequate and innovative technology for the services offered.
Legal or Regulatory Framework.
Resolution 3100 of 2019. Manual for Registration and Authorization of Health Service Providers.
Statement of Management commitment to the Policy.
The General Management undertakes to:
Have a Strategic Plan for technology that allows the incorporation and renewal of technology in accordance with institutional advances.
Guarantee continuous training in the use of technology by staff.
Arrange the resources to manage the prioritized risks that due to technology and its misuse may arise in the institution.
Responsible for compliance.
This policy applies to all employees of the institution, since when talking about health care technology, reference is made not only to biomedical technology, but also to technology that provides support to all processes such as computers, communication equipment, power plant. , aeration system among others.
Exceptions to compliance with the policy.
For this policy there are no exceptions to its compliance.
Measurement of Adhesion.
Adherence to this policy will be carried out by monitoring the compliance indicator of the equipment preventive maintenance plan to guarantee equipment in optimal conditions for care.
I. Teaching-Service Relationship Policy
Content or Policy Statement.
At the Astorga Oncology Clinic, the training and updating processes of professionals and technicians are part of the provision of services, thus promoting the transfer of knowledge and the acquisition of experience in the development of teaching-service agreements.
Objective or Purpose of the Policy.
Contribute to the transfer of knowledge and strengthening of skills of students who rotate in the institution.
Strengthen the relationship ties with the academy with the aim of contributing to the structuring of curricula that respond to the needs of marketing and provide suitable professionals for the management of current health problems.
Legal or Regulatory Framework.
Decree 2376 of 2010 that regulates the Teaching-Service relationship.
Resolution 3100 of 2019. Manual for Registration and Authorization of Health Service Providers.
Declaration of institutional commitment to the Policy.
Establish Teaching-Service agreements with universities that meet all educational quality requirements and that are identified with the institutional strategic guidelines.
Promote the management of agreements within the clinic to guarantee a positive impact on the transfer of knowledge.
Guarantee students the existence of the necessary resources to carry out the practices within the clinic.
Responsible for compliance.
It applies to all personnel related to the management of the Teaching-Service agreement, from the leader who coordinates them to the process leaders and medical specialists who are part of the technical support in student training.
Exceptions to compliance with the policy.
This policy applies to collaborators and students related to the complete management of the agreement. Likewise, it must be understood by the university or technical institutions with which there are agreements.
Measurement of Adhesion.
The follow-up to the application of this policy in the institution will be made effective through the follow-up to the minutes of follow-up meetings with each of the agreements.
The results of evaluations by educational institutions such as a practice site will also be taken into account.
J. Safe Environment Policy
Policy Statement.
The Astorga Oncology Clinic is committed to providing a safe and friendly infrastructure for users and collaborators, guaranteeing spaces free of smoke, visual and auditory contamination, which may affect the development of activities and care for users. Likewise, it will tend to the well-being of its workers and for this reason the consumption of cigarettes, alcohol and psychoactive substances or drugs inside the institution is prohibited, since these affect the work environments, aggravate occupational risks, threaten the employee health and safety of care, constituting a threat to the physical and mental integrity of the person, colleagues and users.
Objective or Purpose of the Policy.
Promote healthy and safe lifestyles that impact the quality of life of the institution's employees and users.
Legal or Regulatory Framework (if applicable).
Decree 1072 of 2015.
Declaration of institutional commitment to the Policy.
The General Management of the clinic is committed to:
Develop strategies that promote healthy lifestyles in clinic collaborators and contractors.
Maintain the institution's infrastructure in optimal conditions, fully complying with regulations and recommendations on safe spaces.
Define periodic monitoring of the strategies implemented to measure the impact of the actions.
Responsible for compliance.
It applies to all the collaborators of the institution from their role contributing to the management and monitoring of the risks detected.
Exceptions to compliance with the policy.
This policy has no exceptions to its compliance.
Measurement of Adhesion.
Improved Conditions Proportion indicator tracking.
Proportion of compliance with the Preventive Maintenance Plan for physical infrastructure.
Follow-up to results over time of the psychosocial risk survey.
K. Referencing Policy
Policy Statement.
In search of continuous improvement, in At the Astorga Oncology Clinic, participation in systematic activities and events for comparison with best practices is promoted, adapting and adopting those strategies that generate added value to institutional processes and improve service provision.
Objective or Purpose of the Policy.
Gather valuable information from other institutions or internal processes that allows through the learning of good practices to improve the processes of the institution.
Position our internal processes as benchmarks for good practices and contribute to the development of the sector.
Legal or Regulatory Framework (if applicable).
Annex 1 Resolution 123 of 2012: Manual of Health Accreditation Standards in Colombia Ambulatory and Hospital.
Decree 903 of 2014, "By which provisions are issued in relation to the Single Accreditation System."
Resolution 2082 of 2014, "Whereby provisions are issued for the operation of the single health accreditation system."
Declaration of institutional commitment to the Policy.
The management commitment will be carried out through: Definition of guidelines regarding the processes to be referenced based on analysis of the institution and its development or improvement needs.
Arrange the resources for the implementation of the strategies defined as successful and accepted by the institution.
Allow referencing to other institutions as a fundamental element of cooperation and institutional growth, as long as established parameters of confidential and/or discretionary management of established topics are met.
Responsible for compliance.
This policy applies to Management and process leaders who are initially responsible for making the referencing. The other collaborators have the commitment to inform any practice that they believe may serve to strengthen the institution.
Exceptions to compliance with the policy.
There are no exceptions to this policy. The Astorga Oncology Clinic reserves the right to authorize or not the referencing of another institution according to the reception or not of our policies of reserved and confidential management of the information defined as such.
Measurement of Adhesion.
This policy is monitored through the referencing reports carried out and the proportion of improvements implemented as a result of the referencing.
L. Information and Communications Management Policy
Policy Statement.
For the Astorga Oncology Clinic, information is a valuable asset that will be managed comprehensively, guaranteeing its reliability, veracity and security, allowing decision-making based on data analysis at all levels and generating assertive communication of the information. organization.
Objective or Purpose of the Policy.
Promote the safe management of information in general throughout its generation cycle until its custody and seek transparent, timely and effective communication, promoting a sense of belonging and good use of the corporate image.
Legal or Regulatory Framework.
ISO 9001:2015 standard.
Declaration of institutional commitment to the Policy.
Management undertakes to: Periodically define the information needs required to facilitate the means at their disposal so that they can be corrected.
Establish a communication matrix to standardize intra-institutional management.
Apply the Data Protection Policy as a guarantee to the interested parties of the safe handling of their relevant information.
Responsible for compliance.
Applies to all collaborators and institutional instances.
Exceptions to compliance with the policy.
Only relevant information of the interested parties with whom they have a relationship will be shared, in the cases strictly stipulated by law.
Measurement of Adhesion.
Report of failures to data management through the National Registry of RNBD Database.
M. Non-Reuse Policy
Policy Statement.
The Astorga Oncology Clinic guarantees that during the patient care process, medical devices defined as single-use by the provider are not reused, with the aim of ensuring the greatest possible safety in the care of each of our users.
Objective or Purpose of the Policy.
Reduce as much as possible the risk of infections or complications associated with the use of medical devices in patient care.
Legal or Regulatory Framework.
Resolution 3100 of 2019. Manual for Registration and Authorization of Health Service Providers.
Declaration of institutional commitment to the Policy. The General Management demonstrates its commitment to this policy by guaranteeing the purchase of medical devices and supplies defined as single-use by the supplier, taking into account the technical and quality criteria defined in the purchasing process and periodically evaluating our suppliers to guarantee quality. of the products purchased.
Responsible for compliance.
Applies to healthcare personnel who are responsible for the use of medical devices in the institution.
Exceptions to compliance with the policy.
This policy does not apply to collaborators with non-assistance charges and attention to patient health issues.
Measurement of Adhesion.
Monitoring of alarms by Tecnovigilancia.
Follow-up to the report of adverse events related to medical devices.
N. Occupational Health and Safety Policy
Policy Statement.
Or's ClinicOncology Astorga is committed to the protection and promotion of workers' health, seeking their physical integrity through risk control, continuous improvement of processes and environmental protection.
All levels of managemention assume the responsibility of promoting a healthy and safe work environment, complying with the applicable legal requirements, linking the interested parties in the occupational health and safety management system and allocating the necessary human, physical and financial resources to health and safety management.
The programs developed at the Astorga oncology clinic will be aimed at promoting a culture of prevention and self-care, intervention in working conditions that can cause accidents or occupational diseases, absenteeism control and emergency preparedness. All employees, contractors and temporary workers will have the responsibility of complying with safety rules and procedures, in order to carry out a safe job and productive. Likewise, they will be responsible for promptly notifying all those conditions that may generate consequences and contingencies for employees and the organization.
Objective or Purpose of the Policy.
Provide safe and pleasant work environments that facilitate a healthy labor relationship and effective management.
Legal or Regulatory Framework (if applicable).
Decree 1072 of 2015.
Declaration of institutional commitment to the Policy.
The General Management assumes the responsibility of promoting a healthy and safe work environment, complying with the applicable legal requirements.
Integrate the interested parties in the occupational health and safety management system for efficient work and impact within the institution. Allocate the human, physical and financial resources necessary for the management of safety and health at work, intervening in the risks defined as priorities.
Responsible for compliance.
Applies to all collaborators of the institution regardless of their type of relationship. It also covers all interested parties such as external customers, suppliers and users who have some kind of relationship with the clinic.
Exceptions to compliance with the policy.
No exceptions apply.
Measurement of Adhesion.
Follow-up of the indicator of Proportion of Conditions improved in SST.
O. Research Quality Policy
Policy Statement.
Good Clinical Practices are an international standard of ethical and scientific quality for the design, conduct, registration and data reporting of clinical trials in which human beings participate. The Compliance with this standard constitutes a public guarantee of the protection of the rights, safety and well-being of the trial participants and of the credibility of the clinical data of the trial.
Objective or Purpose of the Policy.
Seek the protection of the rights, security and impact on the welfare state of the research subject.
Generate credibility of clinical data generated from all research protocols.
Comply with the guidelines of Good Clinical Practices defined by government agencies.
Legal or Regulatory Framework.
Resolution 2378 of 2008. By which Good Clinical Practices are adopted for institutions that conduct research with drugs in humans.
Declaration of institutional commitment to the Policy. The General Management in conjunction with the Head of Research undertakes to comply with each and every one of the ethical and regulatory guidelines in the field of drug research in humans, seeking to carry out studies that contribute to the quality of life of patients and the community at large. Likewise, guarantee at all times the transparency and veracity of the information derived from these studies.
Responsible for compliance.
Applies to all collaborators who are part of the research studies carried out by the institution. In addition to interested parties such as the Study Sponsor.
Exceptions to compliance with the policy.
No exceptions apply.
Measurement of Adhesion.
Monitoring results carried out on each research protocol.
Result of internal audit of the process.
P. Conflict of Interest Policy
Policy Statement.
The staff of the Astorga Oncology Clinic who participate in research studies must maintain high ethical and scientific quality standards during the conduct of clinical studies, always ensuring the well-being of the research subjects and the integrity and veracity of the data. recorded data. Your personal financial interests should never influence these activities or the interpretation of the results that are performed.
Objective or Purpose of the Policy.
Generate the commitment to prevent and manage conflicts of interest that may arise in the conduct of clinical studies in which the staff of the Astorga Oncology Clinic participate.
Guarantee the generation of reliable and truthful data during the conduct of clinical studies.
Legal or Regulatory Framework.
RESOLUTION NUMBER 2378 OF 2008. "By which Good Clinical Practices are adopted for institutions that conduct research with drugs in humans." Ministry of social protection. Republic of Colombia.
INTERNATIONAL CONFERENCE ON HARMONIZATION (ICH). Carried out in 1996. A unique project in which the regulatory authorities of the United States, Europe and Japan, together with specialists from the pharmaceutical industry from these three regions, discussed the technical and scientific aspects of product registration. They standardized the concepts that are involved in clinical research in order to preserve the rights, well-being and confidentiality of the research subjects and obtain reliable and reproducible data.
Declaration of institutional commitment to the Policy. Taking into account the procedures of the research process, the researchers and their staff in charge (when applicable), must declare their conflicts of interest at the beginning of each clinical study and make it explicit in the format defined for its registration (INV-FR-010 DECLARATION OF CONFLICTS OF INTEREST).
It is the responsibility of the institution, the sponsors of the clinical studies and the Ethics Committee that evaluates the research protocol, the detection, analysis and management of possible conflicts of interest.
Responsible for compliance.
Applies to all collaborators who are part of the research studies carried out by the institution.
Exceptions to compliance with the policy.
No exceptions apply in relation to personnel participating in research studies.
Measurement of Adhesion.
Audit result of conducting clinical studies.
Q. Quality Control Policy
Policy Statement.
Part of quality assurance intended to verify that structures, systems and components meet predetermined requirements, the management system of which provides confidence that specified requirements will be met in accordance with a set of planned and systematic measures necessary to provide credibility that a structure, system or component will function satisfactorily when in service.
Objective or Purpose of the Policy.
Regulate the procedure to carry out acceptance tests, periodic quality controls and verification of the proper functioning of an ionizing radiation generating equipment
Legal or Regulatory Framework.
Resolution 482 of 2018. "By which the use of ionizing radiation generating equipment is regulated, its quality control, the provision of radiation protection services and other provisions are issued." Ministry of health and social protection. February 22, 2018.
Declaration of institutional commitment to the Policy. Taking into account the procedures of the process, the clinic establishes within its management to comply as much as possible with the guarantee of the structures, systems and components of the same in the provision of the service.
Responsible for compliance.
Applies to all collaborators who are part of the Radiotherapy, Diagnostic Imaging and Surgery services
Exceptions to compliance with the policy.
It does not apply exceptions in relation to the personnel that participates and is immersed in the process.
Measurement of Adhesion.
Audit result of conducting clinical studies.
R. Licensing Policy
Policy Statement
The Diagnostic Imaging, Radiotherapy and Surgery services comply with the standards, laws and regulations issued by the Ministry of Health and Social Protection and with the requirements demanded by the Secretary of Health of Antioquia. The licensing procedure for equipment emitting ionizing radiation for Category I and Category II medical practice, in these services they have a valid Medical Practice License to use their equipment.
Objective or purpose of the policy
Regulate the procedure for applying for licenses for medical practices that use equipment that generates or emits ionizing radiation
Legal or Regulatory Framework
Resolution 482 of 2018. "By which the use of ionizing radiation generating equipment is regulated, its quality control, the provision of radiation protection services and other provisions are issued." Ministry of health and social protection. February 22, 2018.
Law 9 of 1979, article 151 by means of which sanitary measures are dictated, establishes that any person who possesses or uses equipment of materials that produce ionizing radiation, must have a license issued by the Ministry of Health, today the Ministry of Health and Social Protection; Article 152 of the same Law determines that this Ministry must establish the norms and regulations that are required for the protection of the health and safety of people against the risks derived from ionizing radiation and adopt the necessary measures for their compliance.
Declaration of institutional commitment to the Policy
Obtaining the administrative act issued by the territorial health entity of a departmental or district nature, depending on the jurisdiction in which the facility is located, through which the health service provider is empowered to use the equipment that generates ionizing radiation during a determined period, prior to meeting the requirements referred to in Chapter III of Resolution 482 of 2018 or the preceding one.
Responsible for compliance.
Applies to all services that use ionizing radiation emitting equipment for diagnosis or treatment at the Astorga Oncology Clinic.
Exceptions to compliance with the policy.
It does not apply exceptions in relation to the personnel that participates and is immersed in the process.
Measurement of Adhesion.
Audit result of conducting clinical studies.
S. Labor Disconnection Policy
Policy Statement
The Astorga Oncology Clinic favors that workers can effectively and fully enjoy rest time, licenses, permits, vacations and their personal and family life, for which it promotes that communications, orders or other requirements that are made for related issues with the scope or work activity are only carried out during working hours.
Objective or purpose of the policy
Ensure that all areas schedule and hold meetings, training sessions and other work-related events, within working hours.
Legal or Regulatory Framework
Law 2191 of 2022. ´´This law has the purpose of creating, regulating and promoting the labor disconnection of workers in labor relations within the different contracting modalities in force in the Colombian legal system and its forms of execution, as well as in the legal and/or regulatory relationships, in order to guarantee the effective enjoyment of free time and rest times, licenses, permits and/or vacations to reconcile personal, family and work life.
Declaration of institutional commitment to the Policy
Taking into account the procedures of the process, the clinic establishes within its management to comply as much as possible with the guarantee of the structures, systems and components of the same in the provision of the service.
Responsible for compliance.
Applies to all collaborators and institutional instances.
Exceptions to compliance with the policy.
This policy does not apply to employees who hold management, trust and management positions; likewise, in situations of force majeure or fortuitous event, in which it is required to fulfill extra duties of collaboration with the institution, when necessary for the continuity of the service, to solve difficult or urgent situations in the operation, provided that Justifies the non-existence of another viable alternative.
Measurement of Adhesion.
Safety and health inspections at work, by the contracted advisor.
BIBLIOGRAPHIC REFERENCE.
https://ieels.jimdo.com/pol%C3%ADticas-institucionales/(2).
http://www.mas-business.com/docs/Modelo_indicadores.pdf
IAEA TECHNOLOGICAL SECURITY GLOSSARY. Terminology used in nuclear safety and radiation protection, IAEA, 2007.
JOINT COMMISSION INTERNATIONAL. Joint Commission International Accreditation Standards for Hospitals. 6th edition. AOP 6. | Effective July 1, 2017. Oakbrook Terrace, Illinois 60181 USA Department of Publications Joint Commission Resources One Renaissance Boulevard. 2017.
15. ANNEXES
DECLARATION OF ADHESION TO .__________________________
As part of the Risk Management in the provision of the Service of _______________________________, I declare that I fully adhere to all the guidelines given in relation to Patient Safety and the activities related to its promotion and management.
To comply with the foregoing, the independent professional undertakes to:
● Participate in the induction and reinduction process to guarantee the continuity and updating of knowledge.
● Monitor and report incidents and adverse events that occur during the provision of the ___________________ service through the formats defined in the clinic's procedures.
In addition, follow up on critical processes that may affect your clinical practice, such as: measurement of the opportunity to assign appointments, patient complaints, level of general satisfaction, maintenance of qualification conditions, results of measurement of adherence to the Registry of Criteria of HC and GPC.
● Participate in the medical staff (Tumor Committee) that take place at the clinic, where they will notify detected security events.
● Be an active part of the Patient Safety Committee in cases where it is required due to the effect of analysis of related safety events with your attention and in the other Committees that apply according to your intra-institutional practice.
● Promote safe practices implemented as safety strategies to strengthen the culture in the clinic from the care in the clinic.
● Participate in the security survey that is carried out within the clinic as part of the measurement of the impact of the culture of security and detection of gaps to be impacted.
● Participate every semester in the measurement of adherence to the instructional packages implemented in the clinic that are directly related to the _________________________ service.
Freelance Professional Name:
Type and identification number:
Specialty: