Policy On Policy (eng).docx

1. Objective 1.1 To provide the document formatting in the quality system of the organization in the same standard. 1.2 To provide a detailed guideline of the document control and ensure that records are recorded in the center's quality system which is accurate, reliable and current. 1.3 To provide a process of managing documents, information, external information in order to use in the center which is accurate, reliable, secure and ready to use. 1.4. To provide a detailed guideline how to access documents in the quality system and employees are expected to understand and apply the same standards across the organization.

2. Policy

2.1 The quality system must be current and ready to use wherever the document formatting of the document is determined and readily readable. There are 3 levels of document classification in the quality system. Level 1: Hospital-Wide document The Plan (P / L) must contain the title of the document. (See Appendix 1.1.) Hospital Policy Policy (S / P) must contain the title of the document and the document formatting (See Appendix 1.2 for details) Level 2 Relevant Document or more than 1  The Clinical Practice Guidelines (CPGs) must contain the topic of the document and have the document format. (See Appendix 1.3)  The Work Procedure (WP) must contain the title of the document and have a document format. (See Appendix 1.4.)  Forms (FM) must be properly aligned with the standard operating procedures. Form (Clinical) Form 1 (Form FM) that a physician or a multidisciplinary physician uses to record patient orders, such as the Order sheet, is the original form and has the head document format (See Appendix 1.5.) Form 2, Form F (FM) Forms that are not included in Form 1, use the header and footer format. (See Appendix 1.6.) Form (Non-Clinical) Form 1: Forms used outside the hospital which will be used headers and footers (See Appendix 1.7) Form 2: The form used inside the hospital or within the department. Use headers and footers. (See Appendix 1.8.)  Patient Instruction (PI) is Patient Instruction (Procedure) must contain the topics of the following documents.

1. General Information 2. Alternative Treatment/Procedure 3. Specific risks 4. Pre-Post Treatment/Procedure Instruction Level 3: Specific Documents The Form (FM) (specific) form must be appropriately aligned with the standard procedure for the form. Work Instruction (WI) must contain the subject of the document (See Appendix No. 1.9.) 2.2 Documentation, Review, Approval and Release (MOI Intent) The quality system documentation must be prepared by the compiler in the format specified in the policy. Documents in the quality system must contain the topic of each type of document (as described in 2.1). The quality system documentation must be reviewed by the reviewer and presented to the approver prior to adoption. Use the procedure in Article 5. 2.3. Document Review Process in Quality System (MOI Intent b) To ensure a quality document is up-to-date. The hospital requires the compiler to process the relevant quality system documentation. The time required to revise the relevant quality system documentation at least every 2 years or every time there is a significant change. The quality of the documents is correct and current. The compiler will submit the revised document for approval to the reviewer and the approver in accordance with the same procedure as for obtaining approval in the quality system. Use the procedure in Article 5. 2.4. To ensure that the relevant quality system document control system is up-to-date and available in all areas of use (MOI Intent c)  The hospital provides the policy of employees’ permission to access documents in the quality system through computer systems only. Do not allow staff to print documents from the quality system and a hard copy is not allowed to keep in the department.  The documents such as Form, Patient Instruction, Support document are allowed to print it out only once as needed and not allowed to keep in the department  If the department wants to print other documents. It requires to get permission from the document controller. When the document is printed it out, it will be classified as “uncontrolled document”. It is necessary to keep the document in the quality system as a reference document. This is because the document is accurate and current.

2.5. Identification of changes of quality system documentation (MOI Intent d)  Any changes to the document should be made with red ink, or with red medium point pens on the content / sentences. An exception of Form (FM) and Patient Instruction (PI) does not need to make with a red color on the text/Sentences. However, it must be mentioned in the Revision History Section at each time. (see the attached form)  A complier must provide details of the modifications and reasons for revision in the Revision History section. (See 1.10) 2.6. Formatting documentation in the quality system (MOI Intent e) To design a format of document in the quality system using the format "Type-XX-YYY-ZZZ" which is the following; Type = Type of document XX = Document Category YYY = Short Form of Department Name / Main Board ZZZ = (Running Number) The procedure for assigning a document number to a quality system in accordance with clause 6.4.1. 2.7. Document Management in Quality Systems Out of Hospital (MOI Intent f)  External documents such as Support Document (SD) effects on the quality system which is needed to be brought into the quality system as the following procedure in 6.10. 2.8. Documentation Management (MOI Intent g)  The document in the original quality system that have been signed by the approver will then be maintained in the Quality Control Center file. All employees can be able to access and view the documents in the quality system only.  The case of patient’s medical records shall be store by the medical document controller (refer to S / P-01-BPK-003)  Document Retention - All Medical records must be retained for as long as required by national law and regulations, it must be maintained for 10 years (Refer to S / P-01-BPK-003)

- Non-Medical Record documents will be retained for 5 years or must be maintained per the hospital retention requirements as specified in the policy (Refer to S / P-01-BPK-003) 2.9. An approved document will be scanned and stored in the computer system. All employees can be accessible to the quality system and it must be strictly complied with Clause 2.4. 2.10. All relevant staff must be trained how to access the document in the quality system and the content related to the document. It is important to understand and be able to access documents in the quality system which will meet the same standards throughout the organization. 2.11. Existing policies and procedures will be monitored by a committee involved in the quality system. The Tracer Round is required to assess the effectiveness of policy implemented and review the ability of the staff adopted the policy into effectively.

3. Scope This guideline covers the document management systems in quality systems. The documents are formatted and numbered into the standard form which is clear, readable including external documents. 1. Internal documents includes;  Bylaws (B/L)  (P/L)  Hospital Policy (S/P)  Clinical Practice Guidelines (CPGs)  Work Procedure (W/P)  Work Instruction (W/I)  Form (F/M)  Patient Instruction (P/I) 2. External documents include;  Professional standards  Hospital quality standards, HA, JCI  Laws, Act, Requirements, Notification, Ministry or other related to quality system and environmental management systems.  Other documents that affect the quality system. And environmental management systems.

4. Definition Terminology Definition / Description 1. Bylaws Corporate Statute Applicable regulatory (B/L) requirements throughout the organization. 2. Plan (P/L) A hospital-level overview, provided that it is prepared. Or plan to support the readiness to perform. Include plan implementation, recording and evaluation activities. It specifies the scope of the system. Comprehensive requirements All relevant departments within the organization are in the same direction. 3. Hospital "Policy" is a document that identifies Joint Policy (S/P) practice at the Bangkok Phuket Hospital. Current expectations of the hospital. Provide guidelines for Decide on action for all employees. Specifically Management Quality system. And patient safety. Environmental And the occupational health and safety. 5. Clinical A systematic written statement that helps decision Practice makers and professionals in health care choices Guidelines for specific clinics. Message contains Suggested (CPGs) evidence is empirical evidence. Strictly monitored and systematic through to synthesis. Guidelines for treatment of specific patients. 6. Work Quality in the system. Departmental or Procedure departmental level This will include a description (W/P) of how the department works with more than one department involved, as well as the "operating procedures" of the various departments of Bangkok Hospital Phuket. Repeat daily work. Well, that was approved to be a major practice. Identify responsibilities. And the detailed procedures of each department concerned. To be effective and effective coordination.

7. Work Instruction (W/I) 8. Supporting Documents (S/D) 9. Form (F/M) Terminology 10. Patient Instruction (P/I)

11. EDocument (Electronic Document control system) 12. Mandatory document 13. Documentati on in progress 14. Document Control Center (DCC)

"How to work" is documented in the quality system. Describe the details. How does each step work? Every step of the process (step by step) for the operator will not err and ensure that it will work efficiently and effectively. "Support Document" is a document in the quality system. One of the knowledge. Use references or extended explanations. With details. Of comparative data To facilitate the correct operation. The "form" is used to record or record the results of standard activities performed at Hospital . Definition / Description "Document in Quality System Provides information on the treatment that patients receive. "Indications for treatment, benefits. Complications after treatment / surgery, post-operative The patient is fully informed and involved in the decision. Get treatment Electronic document control system Only documents in the quality system are Bylaws, SP, WP, WI, SD, FM, PI. By electronic system And control to meet the policy. Quality system documentation Address in the electronic system. It has been approved and promulgated. Quality system documentation With the new request. Or ask for a correction that is still in print or waiting for review or approval. Or promulgated The Quality Control Center of Bangkok Hospital Phuket

15. composer

16. Reviewer

Terminology 17. approvers 18. Document Controller

19. Quality system documentati on

20. Control document 21. Document not controlled

Quality system documentation It may be shared with a team or committee that has the knowledge and responsibility to perform that task. And write what it takes. Actual practice It must be responsible for revising, revising and / or changing operational guidelines. Those who have a thorough knowledge of the quality of documents in the system. And check the accuracy of the content. Quality system documentation The results of this study are as follows. The operation and compliance with the standards of Bangkok Hospital Phuket. คำอธิบำย Signed approval in the quality system documentation. To make the documents in the quality system effective. And implemented in Bangkok Hospital Phuket. Document collectors in quality systems, as well as accurate collection. Redundancy Compliance with corporate policies. And comply with relevant standards. Formatting is a unique style of each document in the quality system. It is in a clear, easy to read format. Determining the number of control documents in the quality system. A document detailing the quality system that is associated with the process and the results directly related to the quality of the service provided in the operating procedure, which can be in the form of a document and a computerized document. The number and format of the documents are clear. All types of documents are documented and documented in the document control system. The documents in the quality system are printed out of the document control system as "uncontrolled documents." Only for communication. "

5. Duties and Responsibilities Determination of rights / duties in approving documents Classified by type of document.

Type Rights

composer

Reviewer

1. Bylaws (BL)

Main Board

Chairman of the Board

Annou nce Approvers1 Docum ent Executive DCC Committee

2. Plan (PL)

Main Board

Chairman of the Board

Executive Committee

DCC

3. Clinical Practice Guidelines (CPGs)

Chairman of the Board PCT

Chairman of the Quality Development Board (QMC)

DCC

4.Hospital Policy (S/P)

Board/ Managers assigned.

5. Work Procedure (W/P) Patient and standard cases Case is not about patients 6. Work Instruction (W/I) Patient and standard cases Case is not about patients. 7. Supporting Documents (S/D)

Board/ chief / Assigned person

Chairman of the Quality Development Board (QMC) Chairman of the Board / Manager

Chairman of the Medical Executive Committee (MEC) Board Manageme nt (HEC)

Chairman of the Quality Developme nt Board (QMC) Line manager Manageme nt by line

DCC

chief

Line manager

Manageme nt by line

DCC

chief

Line manager

Manageme nt by line

Board/ chief/ Assigned person

Board/ chief

Chairman of the Quality Developme

chief

DCC

DCC

DCC

nt Board (QMC)/ Manager 8. Form (F/M) Form (F/M) (Consent Form) Form (F/M) (Medical Record) 9. Patient Instruction (P/I) 10. Service Profile (SP)

chief/ Assigned person chief/ Assigned person chief/ Assigned person chief/ Assigned person chief/ Assigned person

Manager

Line Director

DCC

Board PFR

Information Board (MOI) Information Board (MOI)

DCC

Chairman of the Board PCT Executive Director

DCC

Medical Records Committee (MR Committee) Related Managers Related Managers

DCC

DCC

6. Procedure 6.1 The process of documents in the quality system, according to the format of the document (Document format/ template) will be divided into four types of documents in the quality system as follows. 6.1.1 Document format (by-law, policy, WI, WP) will follow the format as specified in Clause 10 (Forms and Relevant Document);  Document Control Profile  Document History  Heading will be classified by the level of the document (refer to 2.1). 6.1.2 The document format such as Hospital plan, manuals, or references to the work will follow the format as specified in Cluase 10 (Forms and Relevant document).

6.1.3 The document format such Form will follow the format as specified in Cluase 10 (Forms and Relevant document). 6.1.4 Examples of flow chart and abbreviations for positions and departments / divisions shall be used as specified in Clause 10 (Forms and Related Documents). 6.1.5 Format of end-of-book reference Provide details of the reference. (External document): The American Psychological Association reference style uses the AuthorDate format.  Refer to the Publication Manual of the American Psychological Association (6th ed.) for more information.  When quoting directly or indirectly from a source, the source must be acknowledged in the text by author name and year of publication. In-text; to cite information directly or indirectly, there are two ways to acknowledge citations: 1) Make it a part of a sentence or 2) put it in parentheses at the end of the sentence. Direct quotation –use quotation marks around the quote and include page numbers 1) Cohen and Lotan (2014) argue that "many different kinds of abilities are essential for any profession" (p.151). 2) “Many different kinds of abilities are essential for any profession" (Cohen & Lotan, 2014, p.151). Indirect quotation/paraphrasing/ summarizing –no quotation marks 1) Professional knowledge alone does not make someone a very capable professional (Cohen & Lotan, 2014). 2) According to Cohen and Lotan (2014), professional knowledge alone does not make someone a very capable professional. Citations from a secondary source 1) Gould’s (1981) research “raises fundamental doubts as to whether we can continue to think of intelligence as unidimensional” (as cited in Cohen & Lotan, 2014, pp. 151-152). 2) Intelligence cannot be believed to consist of one single entity any more (Gould, 1981, as cited in Cohen & Lotan, 2014). At the end of the document, you are required to provide the full bibliographic information for each source. References must be listed in alphabetical order by author

6.2 When the document is submitted to the Board / Manager / Line Manager, as the case may be (see Table 5), the document will be reviewed and signed by the approver. It will be considered as follows;  It depends on the purpose and having a policy / Clinical Practice Guidelines  Is the policy or CPGs redundant or related to another policy or CPGs?  Does the policy or CPGs conflict with existing policy and regulatory requirements?  Identify a responsible person and relevant personnel at workplace in each step clearly  Propose the working time period and schedule  It will ensure that Work Instruction (WI)/ Work Procedure (WP) are in line with realistic and actionable practices on daily basis and it is in line with standards including documents from CPGs, relevant standards, WP, WI, forms, etc. Clinical Document Case 1. Relevant Medical documents such as Clinical Practice Guidelines (CPGs) will be proposed by the committee to the QMC Board for reviewing and the Medical Executive Committee (MEC) will be finally approved. 2. In case of medical record form after approval by the supervisor, the document will be sent to the medical record committee for review and submitted to the MOI committee for approval 6.3 When the documents in the quality system have been approved by the MOI committee (see Table 5), the compiler shall submit the documents in the quality system to the document control staff in order to validate the redundancy and the format of the document. 6.4. If the format of the document is accurate in the quality system, then the document controller must provide the document number including the revision and specify the date of enforcement. 6.4.1 Quality Assurance Documentation Number of times reviewing the document in the quality system. Date of mandatory documents in the quality system and how to determine the category of documents in the quality system. Definition of the category in the format document. 01 refers to the category of managed services. 02.1 refers to the category of clinical services. 02.2 refers to the general service category. 03 refers to the environmental division. Occupational Health and Safety 04 refers to the category of recording and documenting.

05 refers to hospital. 06 refers to

the category of external documents used in the Human Resources.

Reference Number Description in the quality system. In order to qualify for a 3-digit number, start with the first letter 001. If the document is cancelled for use, the original numbers will not be re-used. If more than one language is used, the same digit numbers will be used and the acronym of the language will be added at the end.  F/M-XXX-YYY(T) Thai Form  F/M-XXX-YYY(E) English Form  F/M-XXX-YYY(R) Russian form  F/M-XXX-YYY(G) German Form  F/M-XXX-YYY(J) Japanese form  F/M-XXX-YYY(C) Chinese Forms " Type-XX-YYY-ZZZ " Type = Type of document XX = Document Category YYY = Short code of Department Name ZZZ = Document order (Running Number) Example: F/M-DCC-001(E) defines as “the document control center No. 1 in English“ A Revision number of Format Document "Rev.x"

When the document is created in the quality system, the Revision number should start at 0 (Rev.0) and then the document is revised for the first time as specified in “Rev.1”, the second time (Rev.2), respectively. Example 1. F / M-04-DCC-001 (E) Rev.0 defines Document Control Center No. 1 in English. Revision no.1 Example 2 F / M-04-DCC-001 (E) Rev.1 defines the document control center No. 1 in English. Revision No. 1 How to set the date mandatory documents in the quality system. “DD/MM/YYYY”

DD = date of enforcement using numbers such as date 1, date 12, etc. MM = month of enforcement using 2 digits such as 03 (March) YYYY = Year of Enforcement Using 4-digits such as 2018 For example: F / M-DCC-001 (E) Rev.1 (1/01/2018) means Document Control Center No. 1, English Revision no. 1, effective January 1, 2018. When the format completed, the document controller will announce through the organization/department and relevant documents will be prepared and up-to-date 6.5 The Document Master List will be prepared by document controller in order to keep up-to-date.  an originally signed document will be kept in the Quality Documentation Center.  Soft Copy of all documents will be stored on the computer with Online- Document 6.6 Revision or edition of documents in quality systems.  The document will be reviewed, edited periodically at least every 2 years or every time a major change is made. If changes are made in the clinical practice guidelines, it can be reviewed or amended before the scheduled time or later, but not later than in the due year.  Review and revise the documents in the quality system. It can be done due to the following reasons; - The current practices are changing. - Applicable laws or regulations have changed or modified - Due to technological progress, new knowledge and relevant research - The outcomes of quality improvement. - Having new equipment or technology involved. - Having issues related to patient rights that change.  If the document in the quality system is required to be changed, texts or contents should be marked in red color which is different from the original document and then it will be sent to the reviewer and approve through the procedures in Article 5. 6 .7 Cancellation of the document can be used when Policy, WP, WI, etc. which are changed  The department requires to cancel the document which can be followed the flow of cancellation system.

 When document approved by authority, cancelled document will be announced by the Document Controller, notifying to staff in the department. Also, the copy which is cancelled in the work place will be destroyed in order to prevent from using it.  the formatting numbers will no longer be used. 6.8 Document destruction in quality system The new quality system is announced. Or cancel the document in the quality system. Relevant departments and documents in the quality system are in possession or have a copy for use in It has the duty to eliminate the destruction of documents in the original quality system. Follow the hospital information management guidelines. (S / P-01-KTY003) to destroy documents in each quality system by:  Document papers will be destroyed in a manner that does not allow to be retrievable and  If it brings to reuse, the paper will be crossed out and do not allow to reuse the medical records.  Or return back to the document control center.  Medical records are not allowed to reuse or sale purposes. Medical records must be shredded or destroyed. 6.9 If the originally approved documents need to be translated in other languages, the document controller will corporate with a certified translator.(F / M-04-DCC-003) 6.10 Document Control in External Quality System (SD) External documents include textbooks, academic books, forms, documents, tool manuals. The department consider them as a part of reference, if these are involved with the Quality and Patient Safety, Environmental Management, Occupational Health and Safety Management. The document must be entered into the document control system which follows the procedure in clause 5, revision in clause 6.6 and cancellation in clause 6.8.

Flow Chart A draft of policy, WI, WP ect. will be submitted by a committee/ a responsible person

QPS

Reference/ljhth Edition Joint Commission on International Standards for Hospital, 2017 ISO 15189: 2012 Quality management, Document control ISO 22870: 2016 Quality management ISO 15190: 2003 Procedures Find out from www.isothai.com. Update: 19/03/2012 The Quality Mission for Education Graduate School Chulalongkorn University 10. Forms and related documents 10.1 Translation procedures in the quality system W / I-04-DCC-001 10.2. Record the translation. F / M-04-DCC-003