There are many functions and operations that are performed in a hospital. Each function and operations are guided by the hospital’s policy on it and is carried out as per the specified procedure. For the sake of standardization, it is important that these policies and procedures are available in written for staff to refer whenever required. The written policies and procedures are often referred as policies and procedures documents. There is a long list of documents that are required in a hospital and such can differ in its size, form and applicability. This creates problems with managing these documents and leads to frequent errors. What is required is a systematic way of organizing these documents errors and confusions could be avoided. This post describes how to organize policy and procedure documents for an efficient management.
TYPES OF DOCUMENTS
Policy and procedure documents in a hospital are generally of following types.
Manuals: Manuals is a comprehensive document, resembling a book, which provides detail description of topics related to a specific function. The topics in a manual are closely related and relevant to the main theme of the manual. Example of manuals includes Infection Control Manual, Pharmaco-therapeutics manual, Safety Manual, Quality Manual, Department manual etc.
Policy document: Policy document or ‘policy’ is a document which describes the policy of the organization on a specific issue. It can be standalone or a part of the manual; long or short document depending upon the topic and details that is required. A policy document may or may not be appended with relevant written procedure, instructions and formats. Example includes, Antibiotic policy, Sterilization policy, Disciplinary policy, Policy for care of vulnerable patients etc.
Procedure document: Also called as ‘Standard Operating Procedure’ or ‘SOP’ is a document that describes step by step process of carrying out a specific activity. Purpose of the SOP is to ensure that a standardised way is followed uniformly for the procedure. Procedure documents are usually documented for those procedure that involves multiple people or multiple department. It can be in form of description, table, or flow charts. Example includes, admission procedure, discharge procedure, diet distribution procedure, code blue procedure, procedure to transfer a patient etc.
Work instructions: These are more specific than procedure document and is required for an activity step which is usually carried out by single person. Most of the time work instructions are for the purpose of achieving safety and efficiency. Example includes, work instruction for preparing a bed for patient admission, creating a medical record file for new patient, sequencing of patients in OPD, dispensing of medicines etc.
Clinical protocols: Also called as ‘Standard treatment guidelines’, is a document that guides clinical care of a patient. Content of the document is based upon scientific criteria or by agreement between clinicians. Clinical protocol can be documented for a specific diagnosis, condition, clinical procedure or clinical decision making and can be of different forms and structures such as flow charts, description, checklist etc. Example of clinical protocols are handling of head injury cases, Caesarean section, management of comatose patient etc.
Guidelines: Some time general information is required for staff pertaining to a specific activity, which help them in performing their duty in better and safer ways. Guideline documents is used for this purpose. For example, safety guidelines while working in ICU, guidelines for handling a violent patient etc.
Criteria: Criteria document is used for decision making in situation that are routinely encountered by staff in their work. Example, admission and discharge criteria in ICU, criteria for discharge from recovery area of OT etc.
Checklist: The checklist documents are used for ensuring that every critical step in a process has been followed. For example facility inspection checklist, Infection control checklists, Checklist of medical errors etc.
Forms/Formats: In true sense, these are not policy and procedure documents, but a standard template in which record of activities shall be maintained
ORGANIZATION OF DOCUMENTS
There are several ways in which documents can be organized. These are,
Organizing as per levels: A common method to organize documents is as per their level of importance. Described by ISO 9001, documents are split in a 4 level hierarchy as given below
Level 1 – Policy Manual – This documents organization’s policies and systems
Level 2 – Procedures – This documents methods of carrying out a function
Level 3 – Work instructions – It documents details of specific task or activities
Level 4 – Other documents – This includes documents such as forms, tags, labels etc.
Advantage of organizing documents as per level is that it emphasizes importance of the document. Also this system provides documentation uniformity in all documents at same level. The drawback of the system is that information related to one particular functions gets split into different levels thus not available at one place for a user to refer.
Organizing in departmental manuals: In this, all documents pertaining to a department is grouped together in form of a manual. The manual becomes a comprehensive book that contains all information necessary and relevant for a department. In addition to departmental manual, there could be manuals of central functions also. Benefit of organizing documents in manuals is that users of a department can access all relevant information with one manual and that all necessary information gets documented. There are however few disadvantages with this type of organization. One is that often the manuals become bulky document and not so user-friendly when a specific information is being sought for. Another is that there are plenty of activities which primarily belong to one department but may also be required by other departments for reference. However, due to department wise manual organization, these kinds of information are not readily available to other departments. Yet another disadvantage is that it may affect the uniformity of an activity in different department if documented differently in their manuals
Organising in manuals and procedures: This method is kind of a mix of the above two, where major policies and systems of the organization are documented in manuals and the detail procedures are documented separately. This method has the advantage of grouping the documents in two levels. The drawback is that comprehensive information on one activity is not available at one place. Distribution of documents may be a problem as the entire manual need to be issued to all departments.
Organizing as individual documents: This method provides a large amount of flexibility in distribution, issue and control. Entire information pertaining to a process or activity, such as policy, procedure, instructions and formats are documented in the same document. Each document becomes a complete of information for an individual process which is useful for employee. Distribution also becomes easy as you can issue the complete set of information to all relevant departments. In addition to individual documents, the HCO can have few manuals to describe broader functions or details about organizational systems. The only disadvantage of this system is that it does not identify importance of any document as all are at same level.
DOCUMENT IDENTIFICATION
Due to a large number of documents in HCO proper identification of each document is necessary in documentation system to avoid confusion. There are few important details to be identified for every document, to ensure its proper management and organization. As a good practice, each and every page of the document should have its major identification details. Typical identification related details put on documents are as given below
· Title of the document: Title should be self-explanatory and should give a good idea of what the document is about and where is it applicable
· Document number: Each document should have a unique identification number which can be used for reference. A uniform numbering system can be followed across the organization. A good idea is to follow a numbering technique in consonance to the document organization method so that the document number also indicates which group of document it belongs to.
· Name of the manual/category – Depending upon the organization method being followed the manual or department or category to which the document belongs to should be mentioned on it
· Issue/release date: The latest date on which the document was issued/released last in the organization should be mentioned
· Issue number: The document can be re-issued after a certain period of time due to changes in it. Hence the latest issue number should be mentioned
· Revision/Amendment number: Sometimes some portion of the document gets amended and hence the latest amendment number of the document should be mentioned
· Revision/Amendment date: Date corresponding the last amendment/revision should be indicated on the document
· Review due date: A good practice to maintain documents up to date is to have a defined periodicity of reviewing the existing document for necessary up-dation. Hence a review due date should be put on the document which serves as a reminder.
· Other: besides this, other information that can be put on the document are 'name of the hospital, name and signature of the document preparer and name and signature of the person approving the document
Unnecessary information should be avoided from documents to make it free from clutter. A working practice is to put a header and a footer having above identification details on every page of the document. A sample header and footer is given below.
Header of the document
‘Name of the Hospital’
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Name of the manual / category of document
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Document no:
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Issue No:
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Issue Date:
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Review due on:
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Title of the document
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Footer of the document
Prepared by (Name and Signature):
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Approved by (Name and signature)
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Page no.---of ---
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DOCUMENT CONTROL
Document control system is required to ensure the validity and legitimacy of the document is maintained and unauthorised access to document are prevented. Since these documents contain entire policies and functioning of an organization unauthorised changes or access may cause serious problems in organizational functioning. Hence to prevent this, following measures should be incorporated in documentation system for controlling documents.
Authenticity: All documents under documentation system should have following features to be considered as authentic
• Document is on an approved template followed under the system
• The original copy of the document should bear the signature of the approving authority in original. Authority to approve a document is only with Head of the organization and Head of the departments
• Copies of the document for issuing within organization should be photocopied from the original only and should be stamped as ‘CONTROLLED’ on every page
• Copy for issuing outside the organization should be photocopied only from original and should be stamped as ‘UNCONTROLLED’ on every page
• Document can be issued only by the quality manager, who maintains a record of issues and dates
Access to documents: Documents can be accessed only by staff of the organization to whom it has been issued. Only the issued copy can be accessed and no photocopies or photographing of the documents should be done. In case copies of the document is required a request can be made to quality manager who can issue uncontrolled copies as required
Maintaining documents: The documents are issued to an identified personnel in department and he/she should be responsible to maintain the document in proper form and prevent any loss, damage or theft of the document. Following instructions must be followed
• Documents are stored in a place where it can be accessed by staff but is prevented for theft, loss or damage
• At closing time (for applicable departments), the documents should be kept in lock and key
• No staff allowed to make any changes or modifications in the controlled document
DOCUMENT PREPARATION, APPROVAL, REVIEW AND ISSUE
A standard process should be followed for preparing, reviewing, approval and issue of documents within the system. The process should ensure that right information gets document in appropriate manner and is distributed to relevant departments and staff.
Document preparation:
Topics or issues that needs a document should be identified for the purpose of preparation (check this list). Needs can be generated and identified by departments, committees, accreditation requirement or as a result of operational necessity. Whenever such need of a document is identified it should be communicated to quality manager (or person responsible for documentation system), who would initiate documentation preparation process
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• Depending upon the topic a relevant person from staff should be identified to draft the content of the document. Relevant information to be incorporated in the draft should be communicated to the preparer, based upon committee decisions or other sources. A coordinator from quality department should help the content preparer to ensure that template, language and other requirements are incorporated in the draft
• A timeline should be given for completing the draft after which it should be submitted to the quality manager
• Depending upon the topic a relevant person from staff should be identified to draft the content of the document. Relevant information to be incorporated in the draft should be communicated to the preparer, based upon committee decisions or other sources. A coordinator from quality department should help the content preparer to ensure that template, language and other requirements are incorporated in the draft
• A timeline should be given for completing the draft after which it should be submitted to the quality manager
Document review: The prepared draft should be reviewed by an identified reviewer to ensure that the contents are relevant and appropriate to serve the purpose of the document.
Document approval: After review and incorporation of necessary inputs from reviewer the document shall be approved by the approval authority. Approver should once again review the document and if appropriate, approve with signature
Document issue: After approval, the document should be entered into the system. The coordinator should give identification details of the document, identify relevant departments and person to whom it needs to be issued and issue the same following documentation control measures. A record of issuance with date should be maintained by the quality manager
AMENDMENTS IN EXISTING DOCUMENTS:
If issued documents require amendments after issue, there should be a process to do the same. Need for amendment should be communicated to the coordinator who after confirming the same with relevant personnel should initiate amendment process. Changes should be made in the original copy and amendment number and amendment date should be mentioned. Approval should again be taken from the approving authority. Existing issued documents should be recalled from all places and amended versions should be issued. A summary of changes made in the document should be recorded at front or back of the document. The previous copies should be destroyed, but one original copy should be retained and marked as obsolete, for any future reference.
Electronic copies of documents:
It is very common these days to maintain electronic copies of the documents. Wherever this is being practised, appropriate measures should be taken to ensure adequate document control. Due to number of versions of each document draft, it can sometimes become frustrating for the coordinator to maintain original or updated versions of the document. Hence it is recommended that master copies should be maintained in a specified folder and should be accessible only by one designated authority.
