INSTITUTE OF QUALITY AND ACCREDITATION IN HEALTHCARE
INSTITUTE OF QUALITY AND ACCREDITATION IN HEALTHCARE
INSTITUTE OF QUALITY AND ACCREDITATION IN HEALTHCARE
Название компании
Operating Procedures (SOP) Rules and Standards
What is SOP?
Standard Operating Procedures (SOP) in Healthcare Organizations
ON OUR WEBSITE YOU CAN FIND OPERATING PROCEDURE STANDARDS (SOP) FOR THE MAIN AREAS OF NATIONAL ACCREDITATION STANDARDS.
Definition and History
Standard operating procedures (SOPs) are formal instructions written to standardize the performance of specific functions or tasks within an organization. In healthcare settings, SOPs serve to ensure consistent and safe delivery of healthcare services. These procedures help improve the quality of patient care by providing a standardized approach to treatment and care. The concept of SOPs originated in the manufacturing and military environments of the early 20th century, where clear guidelines were needed to ensure efficient and predictable performance of tasks. Over time, the principles of standardization began to be applied to the medical field, especially as technology advanced and medical procedures became more complex.
SOP and accreditation procedure
In the context of accreditation of healthcare organizations, SOPs play a key role. Accreditation is the process of assessing healthcare institutions for compliance with certain quality and safety standards. SOPs demonstrate that the organization has a systematic approach to managing the quality of healthcare and has clear procedures for all aspects of its work, from patient admission to complex medical interventions.
Impact of SOP on the activities of the clinic and health workers
For healthcare workers, SOPs perform several important functions:
- Training and orientation: New employees can quickly become familiar with requirements and procedures, reducing training and integration time into the team.
- Treatment consistency: SOPs ensure the same level of care and treatment for all patients, minimizing risks and errors.
- Legal protection: In the event of medical disputes, having clearly defined and documented procedures can serve as protection for medical staff.
ALL ABOUT SOP
What is SOP
SOPs are applied to
Types of SOP
Development of SOP
Title page of SOP
SOP Sections
An SOP, or standard operating procedure, is a detailed document that describes specific types of work or procedures within the framework of established norms and rules. Also known as work instructions, these documents serve as reliable guidance for medical staff in clinics and hospitals. They not only help workers perform their job duties accurately and consistently, but also ensure that all necessary quality and safety standards are met. Thus, SOPs help improve the efficiency of medical institutions and improve the level of care provided to patients, ensuring high results and minimizing the possibility of errors.
SOPs, or standard operating procedures, are an integral tool in quality management of medical organizations. They are used for a wide range of tasks:
- Analysis of work in a medical organization allows you to identify bottlenecks and identify areas for improvement;
- Definition of optimal methods of performing work ensures that all procedures are carried out in the best possible way;
- Standardization of processes ensures uniformity and increases the efficiency of operations;
- Simplification of the adaptation process of new employees due to clear and understandable instructions;
- Conducting internal audits using SOPs as criteria for evaluating activities and procedures;
- Knowledge management and recording of accumulated experience of personnel help to preserve valuable practices and ways of solving problems;
- Identification of sources of errors and potential risks in daily activities;
- Protection from possible claims from external auditors, since the presence of approved and observed SOPs is evidence of the organization of work in accordance with the law
The main purpose of creating SOPs is a thorough analysis of the quality of personnel work. The development and implementation of these procedures allow you to identify common errors and failures that occur when performing medical manipulations. SOPs also help standardize the execution of procedures by various specialists and significantly simplify the process of training employees, ensuring a higher degree of reproducibility and quality of medical care
Standard operating procedures in healthcare institutions can be categorized into three main groups, each of which is focused on its specific area of activity:
➤ SOPs for emergency situations
These procedures describe the actions of medical personnel in urgent and unforeseen circumstances that are critical for the safety of patients and the staff themselves. Examples include procedures for responding to anaphylactic shock, handling broken mercury-containing thermometers, and managing cases of breaches in medical waste packaging.
➤ SOPs for routine procedures
These standards establish procedures for performing routine tasks that are regularly encountered in clinical practice. They include, for example, rules for taking venous blood, testing for coronavirus, and gastric lavage. Compliance with these procedures helps prevent errors and reduce the number of complaints from patients.
➤ SOPs related to quality management
These procedures concern the quality management of the institution's internal processes. They may cover internal audits, document management, and response to identified nonconformities in the system. SOPs of this type are often used in organizations operating according to the ISO 9000 series of standards.
Each of these groups of SOPs helps improve the efficiency and safety of medical care by ensuring the clarity and predictability of procedures, which is critical for the quality of medical services.
When developing standard operating procedures (SOPs), it is important to assign this task to specialists with in-depth knowledge of the internal processes and logistics of your healthcare organization. Alternatively, you can consider collaborating with an external company that specializes in developing documentation for healthcare institutions.
If you prefer to develop SOPs yourself, start by using standard templates that should be adapted to the specifics of your organization. After adapting the draft document, it should be agreed upon with the chief physician and specialized specialists. This approach will allow you to identify and eliminate potential errors before the final approval of the SOP, avoiding future problems.
Experts strongly advise against creating an SOP from scratch without previous experience, since such a document may contain significant shortcomings and raise questions from regulatory and supervisory authorities.
Recommended structure of the SOP form for medical organizations
When preparing a standard operating procedure (SOP) form, it is important to adapt the requirements of international standards, such as ISO 9001, GxP, ISO 15189, to the specific conditions and needs of a healthcare organization. It is necessary to avoid copying the standards completely, so as not to create unnecessary empty sections that will not be used.
The title page of the SOP must contain:
- Name of the SOP: A clear and understandable name that reflects the essence of the procedure.
- Identifier (code): A unique code for quick identification of the document.
- Full name and position of the SOP developer: The name and position of the person responsible for creating the document.
- Full name and position of the manager who approved the SOP: The name and position of the person who gave official consent to use the SOP.
- Full name and positions of the employees who approved the SOP: A list of persons who participated in reviewing and coordinating the document.
- Date of development: Date of document creation.
- Date of approval and entry into force: The date the document comes into force.
- Organization seal: If necessary.
Main sections of the SOP:
- Purpose: Description of the document's purpose.
- Scope: Indication of those aspects of activity for which this SOP is intended.
- Employees for whom the SOP is intended: Categories of personnel who must follow this procedure.
- References to regulatory documents: List of documents on the basis of which the SOP was developed.
- Terms and definitions: Definitions of key terms used in the document.
- Abbreviations used: List of abbreviations and their explanations.
- Equipment and tools used: Description of the technical means required to perform the procedure.
- Responsibility for failure to comply with or incorrect application of the SOP: Consequences for deviation from established procedures.
- Description of the procedure, requirements for intermediate control: Detailed description of the procedure steps and control measures.
- Actions in emergency situations: Instructions for actions in emergency situations.
- Algorithm or flowchart: Visual representation of the process in the form of a diagram.
- Procedure for assessing knowledge of SOP and admitting personnel to independent work: Methods for checking employees’ knowledge and criteria for their admission to perform tasks.
HOW AND WHEN TO UPDATE SOPS
Since the healthcare sector is undergoing transformation, SOPs will need to be updated periodically. Update them after laws are introduced, equipment is updated, and in other cases where changes affect the rules for providing specific services.
To avoid having to constantly audit SOPs manually, create an electronic database. Enter the following into it:
- titles;
- dates of introduction;
- who approved;
- who agreed;
- who was given the printed SOP.
If you make changes to the original, employees who previously received the SOP are required to exchange it for a new one upon signature. After issuing the current documents, enter the information into the register.
Where to store internal SOPs
Store original paper versions in the archive of the medical organization, in the safe of the head physician or in a specially equipped room, which is not accessible to third parties. Despite the fact that the SOP cannot be called a secret and important document, the loss of the original will lead to problems. You will have to develop a new one, and then re-train employees on it. If you have created an electronic version of the SOP and signed it with an EDS, then store it on the server of the medical organization. Protect access to the storage with a password, otherwise the SOP can be copied by employees, saved to computers. After updating the document, you will not be able to make sure that the outdated version has been destroyed. As a result, the organization may actively apply rules that will differ from each other.
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