INSTITUTE OF QUALITY AND ACCREDITATION IN HEALTHCARE
INSTITUTE OF QUALITY AND ACCREDITATION IN HEALTHCARE
INSTITUTE OF QUALITY AND ACCREDITATION IN HEALTHCARE
Название компании
Operating Procedure Rules and Standards (SOP)
What is SOP?
Standard Operating Procedures (SOPs) in Healthcare Organizations
ON OUR WEBSITE YOU CAN FIND STANDARDS OF OPERATING PROCEDURES (SOPS) FOR THE MAIN AREAS OF NATIONAL ACCREDITATION STANDARDS.
Definition and history
Standard operating procedures (SOPs) are formalized instructions written to standardize the performance of certain functions or tasks in an organization. In healthcare settings, SOPs serve to ensure consistent and safe delivery of healthcare services. These procedures help improve the patient experience by providing a standardized approach to treatment and care.
The concept of SOPs originated in the manufacturing and military sectors in the early 20th century, where clear guidelines were necessary to ensure that tasks were completed efficiently and predictably. Over time, the principles of standardization began to be applied in the medical field, especially with the development of technology and the increasing complexity of medical procedures.
SOP and accreditation procedure
In the context of accreditation of healthcare organizations, SOPs play a key role. Accreditation is the process of assessing healthcare facilities for compliance with certain quality and safety standards. SOPs demonstrate that an organization is systematic about managing the quality of care and has clear procedures for all aspects of its work, from patient intake to complex medical interventions.
Impact of SOP on the activities of the clinic and medical workers
For healthcare workers, SOPs serve several important functions:
- Training and Orientation: New employees can quickly become familiar with requirements and procedures, reducing training and integration time into the team.
- Consistency of care: 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 provide protection for medical personnel.
ALL ABOUT SOP
What is SOP
SOPs are applied for
Types of SOP
SOP development
SOP cover page
SOP Sections
An SOP, or standard operating procedure, is a detailed document that describes specific activities or procedures within established rules and regulations. These documents, also known as work instructions, provide reliable guidance to medical personnel in clinics and hospitals. They not only help employees 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 health care facilities 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 managing the quality of healthcare 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;
- Determining optimal methods for 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 process of adaptation of new employees through clear and understandable instructions;
- Conducting internal audits using SOPs as criteria for evaluating activities and procedures;
- Knowledge management and recording the accumulated experience of personnel help preserve valuable practices and ways of solving problems;
- Identifying sources of errors and potential risks in daily activities;
- Protection from possible claims from external auditors, since the presence of approved and complied with SOPs is proof of the organization of work in accordance with the law
The main purpose of creating SOPs is to thoroughly analyze the quality of staff work. The development and implementation of these procedures make it possible to identify common errors and failures that occur when performing medical procedures. SOPs also help standardize the execution of procedures among different specialists and greatly simplify the process of training employees, ensuring a higher degree of reproducibility and quality of care.
Standard operating procedures in healthcare settings can be categorized into three main groups, each focused on a specific area of activity:
➤ SOP for emergency situations
These procedures describe the actions of medical personnel in urgent and unforeseen circumstances critical to 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 tampered packaging of medical waste.
➤ SOP for routine procedures
These standards establish procedures for performing routine tasks that are regularly encountered in clinical practice. They include, for example, rules for collecting venous blood, testing for coronavirus, and gastric lavage. Following these procedures helps prevent errors and reduce patient complaints.
➤ SOPs related to quality management
These procedures relate to quality management of the institution's internal processes. These may include conducting internal audits, managing records, and responding to identified system inconsistencies. This type of SOP is often used in organizations operating under the ISO 9000 series of standards.
Each of these groups of SOPs helps improve the efficiency and safety of health care by ensuring the clarity and predictability of procedures that are critical to the quality of health care services.
When developing standard operating procedures (SOPs), it is important to assign this task to specialists who have in-depth knowledge of the internal processes and logistics of your healthcare organization. As an alternative, you can consider collaborating with an external company that specializes in developing documentation for medical institutions.
If you prefer to develop SOPs yourself, start by using standard templates that should be tailored to the specifics of your organization. After adapting the draft document, it must be agreed upon with the chief physician and relevant specialists. This approach will allow potential errors to be identified and addressed before the SOP is finalized, avoiding future problems.
Experts strongly advise against creating an SOP from scratch without prior experience, as such a document may contain significant flaws 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 the medical organization. It is necessary to avoid completely copying standards so as not to create unnecessary empty sections that will not be used.
The cover page of the SOP should contain:
- Title of the SOP: A clear and understandable title 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: Name and position of the person responsible for creating the document.
- Full name and position of the manager who approved the SOP: Name and position of the person who gave official consent to the use of the SOP.
- Full names and positions of the employees who approved the SOP: List of persons who participated in the review and approval of the document.
- Development date: The date the document was created.
- Approval and Effective Date: The date on which the document comes into effect.
- Seal of the organization: If necessary.
Main sections of the SOP:
- Purpose: Description of the purpose of the document.
- Scope: An indication of those aspects of the activity for which this SOP is intended.
- Personnel for whom the SOP is intended: Categories of personnel who need to follow this procedure.
- Links 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 explanation.
- Equipment and tools used: Description of the technical means necessary to perform the procedure.
- Responsibility for non-compliance or incorrect application of SOPs: Consequences for deviation from established procedures.
- Description of the procedure, requirements for intermediate control: Detailed description of the steps of the procedure and control activities.
- Actions in emergency situations: Instructions for actions in case of emergency situations.
- Algorithm or flowchart: A visual representation of a process in the form of a diagram.
- Procedure for assessing knowledge according to SOPs and admitting personnel to independent work: Methods for testing employees’ knowledge and criteria for their admission to performing tasks.
HOW AND WHEN TO UPDATE SOPS
As the healthcare industry undergoes transformation, SOPs will need to be updated periodically. Update them after laws are introduced, equipment is updated, and in other cases if changes affect the rules for the provision of specific services.
To avoid having to constantly audit SOPs manually, create an electronic database. Enter in it:
- names;
- date of introduction;
- who approved;
- who agreed;
- to whom the printed SOP was given.
If you make changes to the original, employees who previously received the SOP are required to exchange it for a new one against signature. After issuing current documents, enter the information into the register.
Where to store internal SOPs
Store the original paper versions in the archives of the medical organization, in the safe of the chief physician, or in a specially equipped room to which third parties do not have access. Although the SOP is not a secret or important document, losing the original will lead to problems. You will have to develop a new one, and then train employees on it again.
If you have created an electronic version of the SOP and signed it with an electronic signature, then store it on the server of the medical organization. Protect access to the storage with a password, otherwise the SOP may be copied by employees and saved on computers. After updating the document, you will not be able to make sure that the outdated version was destroyed. As a result, the organization may actively apply rules that differ from each other.
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