Development of Standard Operating Procedures and Care Plans

This paper hopes to clarify some of the issues regarding the development and use of plans in the delivery of patient care.

“I think one’s feelings waste themselves in words; they ought all to be distilled into actions which bring results.”
—Florence Nightingale

INTRODUCTION: Development of Standard Operating Procedures and Care Plans

In any industry a certain degree of uniformity and standardization of practice is required in order to maximize productivity, efficiency and quality. For most industries, this is achieved through documented plans called “Standard Operating Procedures (SOP)”. Patient care has developed its own approaches and terminology. The time has come to relate patient care practices to that of other industries in order to take advantage of innovations in the latter.

Currently, the need to regulate health services, streamline health care funding and ensure uniform quality of care is increasingly being realized worldwide and has resulted in wider acceptance of the use of standardized documented plans. In many instances, the initiatives are driven by the need to be accountable. Health care funders now determine, or at least influence, what goes into the management of cases belonging to a diagnostic related group and fund services on the basis of case mix.


The quality of any service is a measure of its ability to satisfy customer needs. Clinical service can be designed according to the needs of patient groups defined by the identified diagnosis or health problem. As in any other service, the design and planning of clinical care involves translating the needs of clients (patients) into uniform specifications and standards of both the service delivery itself and more importantly the final outcome of the service.

In the past and to some extent even today, many health care providers question the need for uniformity and standardization for the following reasons:

  • Each patient is very different from another and therefore the care of every patient is special (they claim that design should be on a patient to patient basis; standardization leads to “cook-book” medicine which is considered as dangerous)
  • Clinicians need to make independent decisions in choosing management strategies and actions (according to them plans curtail clinical freedom)

Generally, despite these concerns, there is wider acceptance of the need for standardized plans among healthcare providers. In fact, over the years, health care providers have developed many tools for planning patient care and many have been widely used. However, the structure and content of such plans have not been uniform.

Until recently these care delivery plans are often developed by certain categories of healthcare providers notably nurses. There is now an increasing awareness for the plans to be interdisciplinary. Advocates in the United States emphasize this change in approach by calling the plans Interdisciplinary Client Plans, Critical Pathways, Interdisciplinary Outcome Pathways and many other terms. Somehow, there is a general lack of understanding regarding the meaning of the terms ‘Care Plans’ and ‘Care Pathways’ and the context within which they are to be applied in the practice of health care. Indeed there is a lot of controversy, confusion and inconsistency regarding the use of care plans and clinical documentation within the nursing profession.

Clinicians use the term ‘management of a patient or case’ to refer to the provision of the clinical service or care of a patient affected by an illness. On the other hand, the term Case Management is used by certain health care practitioners to mean the entire care across episodes and inclusive of services not necessarily clinical in nature.

A study of current literature reveals the existence of diverse terms used in conjunction with the planning of patient care. In many instances, new terms are coined for the sake of being different from an earlier term to claim originality and therefore commercial value. A return to basic definitions of terms in the context of various appropriate areas of knowledge especially management science would lead to less confusion. The origins and relationships of various concepts, policies and procedures and the terms commonly used to identify them are given below:

Plans: The usual meaning is the arrangement in advance on how to perform a certain activity. There are slight variations when applied to different endeavours. In architecture, it refers to a representation of the intended physical structure and layout. In management, planning is defined as the activity of selecting strategies, methods, policies, programs to achieve defined objectives. Planning refers to either one or both sequential activities i.e. Structural Plan (Design) and the Implementation Plan (Schedule, Process layout).

Algorithms: When used in mathematics, it is the step-by-step procedure for solving a mathematical problem in a limited number of steps. When used in other areas such as patient care, it is the series of sequential decision-making steps in managing a clinical problem based on some rationale. 

Pathways: Clinical pathway is another term for algorithms when it is used in patient-care activities. It is the predicted or planned series of sequential work processes in managing a clinical problem. As work progresses, a decision making step determines the subsequent alternative series of steps. Part of it deals with process layout e.g. whether simultaneous or sequential. Work flow or care pathways are depicted schematically as work flow diagrams or charts. A critical pathway contains only the critical (important, required) steps or processes with the obvious (mundane) steps left out in the documentation (but not in practice). It is incorrect therefore, to call a pathway a plan. In practice the pathway is didactic but often contains alternatives chosen by the care provider.

Work Schedule: Schedules are sets of care packages usually depicted as tables/matrices containing tasks arranged, bundled together and sequenced according to the Care Pathways. The schedule provides direction to the clinical team on tasks to be performed according to scenarios, occasions, phases of care and events guided by professional, quality and safety requirements. Traditionally schedules are equated with Care Plans. Actually, a care Plan is more than just a matrix or table.

( ( (

Much need to be learned from other industries. It is imperative that strategies, methods and mechanisms that have been proven effective in various industries be used, after careful consideration of their applicability. In manufacturing industries, operations management is concerned with the production of a specific product. The concept of a service product, already entrenched in banking, insurance, tourism and sales, needs to be embraced by health care providers because it allows for the quality of a service to be defined by measurable and replicable characteristics. Indeed, there are more similarities than differences in the approach and in the terminology used. A comparison of the terms used is given below:

Comparison of the Terms used in Industry vs. Patient Care

Care Plan 1

To help improve the understanding of the planning process, it is proposed here that effective and well-accepted modern approaches and techniques in operations and quality management used in other industries be adopted in health care.


Planning is a cognitive process that is part of the series of processes in the delivery of patient care. It can be performed in an ad hoc or formalized manner (described in another article).

Obviously, it is much better for patient care to be planned rather than provided in an ad hoc manner. In current practice, generic plans are designed in advance by experts who have thorough understanding of clinical care processes and the modalities available for investigations, treatment and monitoring. These plans may take the form of Practice Guidelines, Standard Operating Procedures, Care Protocols or Care Plans. Often, a compilation of these plans are made available (after consensus, verification and authorization) to all care providers by the health care facility.

The delivery of the service to a patient with a particular health problem (the service product) is best described in the form of a Standard Operating Procedure (SOP). The Care Plan is the part of the SOP that deals with various aspects of tasks (processes) planned for different periods in the clinical care process. Its structure and content is meaningful only  if the SOP is understood. Although it is common to depict the Care Plan as a table or matrix, this is not be the best way to explain it. Tables limits the amount of content and do not show sequence and layout clearly.

The design of the service for a typical patient with an episode of a specific illness is often called the ‘Plan for the management of a patient’. For all intends and purposes it is equivalent to the ‘Standard Operating Procedure (SOP) and there is no reason not to call it such. The SOP is a detailed but generic plan applicable to the delivery of service to typical patients with a typical disease condition (the service product) in a particular facility or organization. Almost invariably, customization of the SOP would be necessary when the actual care of an individual patient is provided.

Service products can be designed to cater for patient groups defined by their needs which in turn are determined largely by the identified diagnosis or health problem. If the patient has more than one health problem, then combination of the generic plans would be required.


The use in health care of the Standard Operating Procedure (SOP) as a term and as a method of standardization of production or service delivery  is not only possible but also imperative. ‘Care Plan’ as a term and method is still applicable, if it is seen to be part of the SOP and derived from it. Its purpose, structure and content is discussed in later sections of this article.

The design of Standard Operating Procedures, in patient care, uses many tools and their content and structure should have the following characteristics:

  1. Describe an accepted way of managing a case
  2. Clarify objectives of care (expected outcome, therapeutic end points)
  3. Identify variations in patient needs and provide alternatives (Care pathway)
  4. Outline the layout and sequence of tasks (Work schedule, Care plan)
  5. Allocate responsibilities (organization of the care team)
  6. Define the control limits of both processes and outcome (built-in Quality control)


From an operations management perspective, a SOP is used for the following purposes:

  1. Provide information, guidance and decision support
  2. Clarify objectives and targets
  3. Facilitate conformance to prescribed approaches and methods
  4. Be the standard/specifications for quality measurement and control
  5. Act as a guide for staff orientation and training

For the care provider, formalized planning of care, guided by pre-designed plans, provides many advantages including:

  1. Facilitate a more structured plan
  2. Ensure comprehensive content
  3. Encourage proper choice of investigations and treatment  (remove redundancy / duplication & wastage)
  4. Encourage better resource utilization
  5. Provide information and decision support (prompts & reminders)
  6. Give a clear picture of future actions
  7. Communicate intentions to the care team (shared objectives and understanding)

From a service or organization-wide managerial perspective, the use of SOPs can engender the following:

  1. Promote uniformity and standardization
  2. Render a degree of predictability in the supply of various resources
  3. Facilitate conformance by setting the standard or specifications for quality measurement and control
  4. Encourage equitable care and remove bias
  5. Improve staff knowledge, skills and behaviour

From the perspective of strategic management, SOPs provide the foundation based on which changes and improvements can be made and benefits evaluated. A clear example would be the re-engineering of processes when computerized information technology is introduced. Without documented SOPs, the current and earlier practices cannot be compared and it would not be possible to distinguish any improvement.

Therefore, an SOP (case management plan) for the care of a patient with a defined disease condition or health problem (a service product) confers benefits for health care providers, patients and health services managers.

Despite these benefits, the apprehensions regarding “cook-book” medicine and  loss of clinical freedom need to be addressed. These concerns are valid and should be addressed by building in variations, exceptions, alternatives and contingency plans into the design of the delivery of patient care. Even so, the SOP in patient care is a reference document to be used as a guide. It has to be converted to actual  plans before being applied to real care.


Some of the philosophies, principles and strategies that can guide the development of a Standard Operating Procedure for patient care include:

  1. Application of modern management concepts and techniques
  2. Ensuring that the plan is feasible and acceptable to users
  3. Based on evidence-based medicine
  4. Imbued with the Total Patient Care concept (Holistic Care)
  5. Reflect a team approach (care through interdisciplinary involvement and collaboration)
  6. Incorporation of quality standards and quality control
  7. Cater for an enlightened patient, advocate empowerment and encourage self help
  8. Harness information technology

These principles and strategies are deliberated further below.


The Shewhart-Deming PDCA Cycle is the most effective method of developing a plan that is effective and can be implemented. At the start, the strategy, methods and layout of implementation of the plan are thought out and documented (the Plan stage). Simulations, trial runs or pilot projects are carried out (the Do stage). Various quality measures of input, processes and output are measured (the Check stage). These are used to determine feasibility, productivity, efficiency, costs and most importantly, conformance of the outcome to the desired outcome standards. Where shortcomings in the design are detected, changes or fine-tuning is done (the Amend stage). The design of the service delivery may be altered to ensure that outcome meets desired specifications. However, it may be necessary to make only minor changes to the service specifications to make the service delivery feasible. The cycle is repeated for every change made until a satisfactory plan is “Adopted”.

The “PDCA” Cycle

New Picture (64)

Once developed, the plans will act as the standard to be followed by everyone who manages a patient suffering from the disease or symptom complex, within the facilities of the organization. This approach to standardization should not, in any way, discourage practitioners from altering practices in peculiar situations and demands. Allowance for variations may be written into the plans.


The care provider is confronted with a myriad of possibilities when choosing strategies, methods, approaches, technologies and modalities for investigation and treatment. Their effectiveness, appropriateness, efficiency, cost-effectiveness and safety are difficult to ascertain. Yet, it is essential that the SOPs in healthcare are based on evidence as well as consensus. How policies and procedures can be derived from evidence, by taking advantage of tried and tested practices, is outlined diagrammatically below:

Evidence-based Practice of Medicine

Care Plan 2

The development of practice guidelines is a major step in attempting to identify and promote care approaches with proven efficacy and effectiveness (evidence-based medicine). These guidelines when available, provides the ideal basis for developing a system of care.

Practice Guidelines are written documents prepared by experts outlining broad recommendations for management of patients with a specific disease condition based on scientific evidence (research) available in the literature. They vary in detail and specificity, depending on the complexity of the disease and degree of variation in its presentation and in treatment possibilities. (Refer: Cochrane Collaboration)

Guidelines need to be transformed (operationalized) into plans that take into account the resources, environment and objectives of the organizations providing the service. There is a need to show that these plans are feasible and effective before being adopted and endorsed by the people in charge (e.g. Clinical Services Committee, Medical Advisory Committee).


For an SOP (patient management plan) to be comprehensive, cohesive and orderly, the Total Patient Care Concept, philosophy and approach to patient care is adopted. A comprehensive patient care plan based on this philosophy of holistic care addresses all aspects of the patient’s health issues for both the short-term as well as the long-term. The design of these SOPs would require the contribution of all relevant health care professionals involved in the care of each class of patients. This can be achieved through the formation of Interdepartmental or Cross-Functional Teams. The SOP must be based on good evidence (e.g. Clinical Practice Guidelines) supplemented by knowledge and experiences of members of the team. (For details, please refer to the article entitled “The Total Patient Care Concept”).

This concept also calls for each care provider to:

  • be interested in the general well-being of the patient,
  • understand the entire care plan,
  • be able to respond to patient’s queries
  • contribute to the success of the plan, wherever possible


The design of patient care service delivery is similar to the design of other service delivery systems as practised in modern quality management (as advocated by Juran). These involved a systematic sequence of steps i.e.:

  1. Identification of primary needs of the client (the health problem, diagnosis)
  2. Identification of additional needs based on specific client characteristics
  3. Setting the expected or desired outcome
  4. Clarifying the components of the service delivery system
  5. Delineating the sequence and layout of work flow (the Care Pathway)
  6. Clarifying and detailing the processes involved (the Work Procedure)
  7. Choosing the most appropriate technology/modalities to be used
  8. Assignment of responsibilities to service providers
  9. Identifying the monitoring and control measures (Monitoring, Review and Evaluation, Quality Control)
  10. Designing the data documentation tools (Clinical Documentation)
  11. Catering for variations, contingencies and damage control

The topic of Quality by Design is discussed in a separate article.


Patients do not usually present to care-providers with readily identifiable health problems. Therefore, before a service is provided, care providers need to gather information, analyze them and identify the patient’s problems. Proper planning of care requires an understanding of the needs of the patient (defined as a person who is sick). The primary needs is identified through an accurate and comprehensive diagnosis.

A diagnosis is as accurate as the amount and quality of data available to the clinician. At the initial phase, only a broad or general diagnosis may be made but as more investigations and monitoring data are made available a more specific diagnosis is possible. The type of care provided must reflect this degree of accuracy in diagnosis. It must also be noted that management also depends on the variant of the disease and the stage in its natural history. Hence, categorization, staging, severity grading and risk stratification are important prerequisites before objectives of care are determined and the right care path and care plan is chosen. Interpreting the nature of the health problem inappropriately and therefore choosing an inappropriate plan would lead to dire consequences. Work flows, algorithms or care pathways are tools that can assist health care providers to make the right decisions and provide guidance towards accepted processes of care.

Care must necessarily change with changes in diagnosis; care pathways and plans must follow accordingly. In general, plans for a particular patient need to altered according to the changing levels of accuracy of the diagnosis.

A discussion on Diagnosis is available in another article.


The objectives of the service provided (care of the patient) should be determined and clearly stated at the outset and at every phase of patient management. While definitive treatment preferably should be started only when an accurate diagnosis is made, much can be offered to the patient in the interim.

Objectives of treatment or therapy  include a combination of any of the following:

  1. Cure the disease (if possible)
  2. Remove, defer, minimize, limit and alleviate detrimental effects  of the illness
  3. Maintain, restore, or improve health status and physiological function
  4. Avoid or minimize complications of treatment
  5. Prevent deterioration or recurrence

Depending on the potential for altering the progress of the disease, there are three main treatment strategies:

  1. Curative therapy
  2. Containment therapy (by 2O or 3O Prevention)
  3. Palliative therapy

When there is potential for cure or complete resolution of the disease process, every attempt should be made to achieve it. However when complete resolution of the illness is not possibile, other beneficial therapeutic options can be offered with different care objectives.

These three broad strategies may contain all or some of the following types of therapeutic (treatment) approaches i.e.:

  1. Definitive
  2. Symptomatic
  3. Supportive
  4. Preventive
  5. Rehabilitative
  6. Promotive

The priority and sequence of treatment (the workflow or process layout) will depend very much on the type, severity, progress and effects of the illness.

Each mode of therapy needs to be planned so that the essential quality features of the outcome are achieved. These features include:

  1. Effectiveness
  2. Safety (including avoidance of unwanted effects)
  3. Appropriateness
  4. Efficiency (especially timeliness)
  5. Sustainability
  6. Acceptability
  7. Cost-effectiveness

Therefore, setting objectives includes specifying standards of the final and also the intermediate outcomes of care, based on the desired quality features. By considering patients as clients, due attention is also given to the restoration or amelioration of the disrupted quality of life (ability to work, enjoy leisure, attend school and perform daily life activities) as the objectives of care.

Different treatment modalities pose different requisites. Plans need to take into consideration:

  • the conditions required to ensure its success
  • the prevention of adverse effects
  • the steps to be taken when complications occur


The development of effective management plans requires a thorough understanding of clinical work processes. This generic set of tasks, their layout and direction is used by all clinical care providers including doctors, nurses, and allied health personnel.

Procedure and Processes

Care Plan 9

A comprehensive outline of clinical care processes applicable to all cases is shown below as a workflow chart:

The Generic Clinical Process Algorithm


Clinical care Algorithm


Operating procedures are tasks to be performed to produce a product or to offer a service. For them to be standardized they need to be documented in a structured way. There should be a single SOP for a service product. However, alternatives due to variations in the disease or the patient profile can be written in within the same SOP.

Plans must take into consideration the resources, environment and goals of the organization providing the service. There is a need to demonstrate that these plans are feasible and effective  through trial or pilot studies. Before being adopted it should be verified by the persons/committee responsible for Clinical Governance and formally endorsed by the executive body of the organization.


The SOP document consists of various components that address various aspects of care. The components mirror those already in use in other industries (in Standard Operating Procedures) and are outlined below:

Care Plan 4
Content of SOP

Content of the SOP

With training, the nomenclature and conventions used in operations management in other industries can be understood and adopted for use, just as effectively, by clinicians. This would allow people in other fields such as information technology, accounting and management to understand clinical care processes. The documents making up the SOP for a specific disease are discussed immediately below. A more detailed discussion of some of them is given later.

Standard Operating Procedures are descriptions of how work is to be carried out. Each comprises many specific components. Care Pathways and Care Plans do not stand on their own but are part of the Standard Operating Procedure (SOP). The SOP should contain:

  1. A title defining the service product that the plan is designed for.
  2. Care objectives including the quality features of the service and outcome standards (equivalent to quality objectives in ISO quality management system)
  3. Textual description of the various work processes detailing layout, the input, technology to be used, assignment of responsibility  and expected intermediate outcome.
  4. Operational policies defining constraints within which procedures are to be carried out
  5. Work Flow Charts or Care Pathways (the ‘flow’ of the procedure depicted graphically)
  6. Specific Work Instructions or Protocols
  7. The Work schedule and Task lists (the Care Plan)
  8. Guide to use of charts or forms to be used as part of the work process
  9. Reference tables or lists (normal values, regimens, drug dosages etc)
  10. Quality Control Methods (Standards, Check-lists etc. i.e. equivalent to quality procedures in quality a management system)

To clinicians, ‘care’ or ‘the management of a patient’ means the provision of the entire service for patient groups to satisfy their needs which are determined largely on the identified diagnosis or health problem. It is therefore equivalent to the Service product i.e. the service for a typical patient (case) with an episode of a specific illness.


Standard Operating Procedures (SOP) are compiled, indexed and kept as a set of reference documents (referred to as the Work Procedure Manual) and made accessible to care providers.

The SOP describes the plan for providing a service product (service for patients with a particular disease or health problem). It has enough breadth and depth to cater for the following functions:

  • explain the theoretical basis for content and layout of care
  • guide various decisions
  • provide the essential knowledge and instructions to give safe, effective and appropriate care.


The title of the SOP should show that it is designed for a specific disease or health problem. To clinicians ‘the management of a patient’ means the provision of the entire service or care for patient groups defined by their needs which are determined largely on the identified diagnosis or health problem. It is equivalent to the Service product i.e. the well-defined service for a typical patient (case) with an episode of a specific illness. Yet, it is still generic and would need customization it is to be used in the actual care of an individual patient.


A statement defining the objectives of care is essential for every SOP. These may include:

  • expected outcome,
  • treatment end points
  • the intended degree of restoration or amelioration of the disrupted quality of life (ability to: work, enjoy leisure, attend school and do daily life activities)
  • avoidance of side effects or complications of treatment

It should declare the quality policy about the service being offered i.e. a statement of targets, limits and standards with regard to quality.

In an SOP, the Clinical Work Processes are presented in two forms i.e.


  1. A textual description
  2. A work-flow chart


Clinical pathway is another term for work flow and algorithms when it is used in patient-care activities. It is the predicted or planned series of sequential work processes in managing a clinical problem. It provides the mechanism to incorporate alternatives and variations. A ‘critical’ pathway contains only the critical (important, required) steps or processes with the obvious (mundane) steps left out in the documentation (but not in practice). The term pathway has been incorrectly used to describe care plans. If the term care pathway is to be used at all it should be synonymous with Work Flow. The care pathway acts as the foundation upon which care plans are developed ultimately. It is an essential component of a documented SOP.

The pathway of the service to be given is described textually and depicted graphically as a chart based on the generic clinical work flow described earlier. An example is shown below:

Clinical Care Pathway for Care of a Polytraumatized Patient

Process Flow for Management of A Poly-traumatized Patient


The care pathway (work flow)  illustrates:

  1. the sequence of the processes
  2. the process layout (simultaneous, contingent on completion of the previous step or iterative)
  3. the decision-making steps that lead to alternative paths or variations


The whole work procedure needs to be described in text format. In general, the description takes the form of a sequential list of instructions on how to perform processes. At the same time the direction, input, technology to be used, persons assigned to perform the task and the expected intermediate outcome are specified. The operational policies that guide and constraint these processes, such as indications and contra-indications, alternatives, allowable variations and contingency plans, rules and criteria, are also embedded.

The sequence, direction and layout of processes or tasks that makes up a procedure need to be described clearly and in detail. It is best written before or at the same time as the chart is being drawn. In a general sense, the textual description explains each workflow symbol (boxes, arrows etc.) but more importantly, it states the specifications and standards of the care process as well as the operational policies that govern them. Therefore, it is the principal component of the Care Plan.

The main tasks listed below need to be elaborated.

  1. Acquisition and documentation of clinical data (Initial Assessment, Progress Notes)
  2. Acquisition and documentation of data obtained from various investigations
  3. Analysis and interpretation of available clinical data
  4. Deriving conclusions regarding the patient’s health problems (the diagnosis) and documenting it (including severity grading, staging)
  5. Monitoring and charting of clinical parameters (Observations, serial measurements )
  6. Planning management and documenting it (with decision support)
  7. Implementation of plans: Placing orders and carrying out tasks (Performing Investigations, treatment, administering drugs)
  8. Documentation of results,procedures, findings, outcome
    • Results review and interpretation
    • Quality Control Procedures (e.g. check lists)
    • Progress review, assessment of outcomes
    • Communications (Referral Notes, Replies), requests and orders
    • Summaries


At the operations level, the general policies of the institution or service unit are translated into operational policies which define goals or objectives as well as the limits within which tasks or processes are performed. These limits (rules, regulations, targets and standards) may relate to efficiency, quality, costs, responsibilities, preferences and exceptions. Operational policies are embedded within the work procedure (see above).

Example of Textual Description of the Work Processes and Operational Policies

Management of Case of Bronchial Asthma at First Follow-up Visit
01. Take history of frequency of exacerbation, limitation of activity & night-time symptoms
02. Examine patient
03. Perform PEFR
04. Assess response according to these criteria:

  • frequency of exacerbation,
  • limitation of activity,
  • night-time symptoms and
  • PEFR

05. If response is not satisfactory; review patient’s compliance to medication & advice. If the poor response is due to poor compliance then, continue the previous treatment and more effort is made to educate patient on the disease, treatment methods and need for compliance.
06. If compliance is not deemed as a problem then, consider the possibility of the need to re-assign patient to a higher severity class. The medication need to be stepped up accordingly (refer treatment chart).
07. Give explanation regarding the new added medication and further education on use of bronchodilator, use of PEFR meter and self-monitoring chart
08. End the visit and give the patient an appointment date for a follow-up visit in 1 month.


The activities (processes, tasks) within the SOP is broken down into sets relevant for particular scheduled periods or phases of care. This is the Care Plan and it contains:

  • a title indicating the purpose for which it is used i.e. the health problem, the phase of care and any other indication
  • objectives and expected outcome
  • a list of all tasks grouped according to the method or technique or the professional competency

Care plans derived from the SOP remains as a reference document until it is converted into an actual plan by customizing it for the individual patient.

It is helpful to present the overall plan for the care episode as an outline in the form of a table.  Details are not presented in this overall plan but  would be written in the discrete plans for different phases or context of care.

Care Schedule or Care Matrix for the Whole Care Episode

Relationship between Diagnosis, Phases of Care and Care Plans

Criteria for Dividing the Care Episode into Different Phases of Care


Care Episode fora Specific Health Problem

Example of Series of Care Plans for Different Phases of Care (Plan for Acute Myocardial Infarct)

Modules by Phases
Plans at Different Levels of Diagnostic Certainty

The development and design of  Care Plans are described in detail below.


Work Instructions or Protocols provide further details on how certain processes are to be carried out. They are predetermined didactic instructions for performing a certain specific task or process as prescribed or endorsed by the organization. They are usually instructions describing how to:

  • perform of-repeated routine tasks (insert a CV line, catheterize a patient, take a blood specimen, take consent etc.)
  • document (use of standard forms or charts, ),
  • operate machines (user manual),
  • use instruments,
  • use chemicals (safely and effectively),
  • order items (food, drugs, blood etc.)
  • serve or administer drugs,
  • transfuse blood or other infusions
  • other specific tasks

Reference tables or lists may become part of this work instruction. Since a work instructions would be performed in a similar manner at any time, location or for any indication, they may be compiled in a separate manual or folder and only referred to if required. In a computerized system they can be reached through hyperlinks.


This section addresses quality control and quality improvement activities. The quality procedure describes the steps to be taken to evaluate conformance to process specifications and outcome standards. Major parts of it are:

  1. measurement of a quality characteristic
  2. comparing with a set standard
  3. determining conformance
  4. improvement methods

It may be incorporated in the work procedure or written as a separate document (as per ISO 9002:2000 QMS standards).


These are guides to the use of various data documentation forms or charts used by the organization to document results of tasks or processes for the particular service product. Documentation forms should anticipate the data generated by the tasks within the management plan. On the other hand, the forms also provide prompts for the care provider to perform certain tasks to obtain the data. Thus, the form itself acts as a decision support instrument


Clinical care is a knowledge driven and information dependent activity. Modern clinical practice must be re-engineered to take advantage of the advancement in knowledge and practice of clinical sciences, management science, and information and communications technology. Clinical Decision Support is the provision of guidance and knowledge at the point of care. It is an integral part of the Case Management Plan.

Clinical decision support is envisaged not as something separate but as built-in functions within the whole patient care. It is applied through several mechanisms:

    1. Guide to the data to be gathered and captured
    2. Guide to making a diagnosis (diagnostic criteria)
    3. Provision and matching of care plans for various categories of patients
    4. Manual / Computerized analysis and interpretation of results (normal, abnormal, scoring, stratification, grading, staging, comparison with standards for quality control)
    5. Provision of guides, instructions, alerts, prompts, reminders and suggestions,
      • before or during the performance of certain procedures
      • In response to certain situations, occurrences, incidents, non-conformances and abnormalities


These contain information, officially endorsed by the organization to be used by workers as reference. Examples of these include table of normal values, percentile charts, dosage regimens, food menu, expected / control limits, standards, specifications, regimens, recommended drug dosages and charges. Example of lists includes official drug formulary, official terminology, diagnoses and charge codes.

Use of Reference Documents for Decision Support

Care Plan 7
Care Process with Decision Support


A diagnosis is made by interpreting certain variables including signs, symptoms, the results of clinical tests, investigation findings (laboratory, imaging, and endoscopy), monitoring parameters, clinical progress and response to treatment. Through research and experience, the medical profession has identified sets of variables that predict a diagnosis i.e. the ‘diagnostic criteria’. This knowledge can be presented to care providers to aid them in making a diagnosis. In certain instances, especially when a scoring system is used, these predictions have a high level of accuracy. However, a rough guide can be also of use to the clinician.


Having made the diagnosis the clinician needs to clarify further:

      1. which variant of the illness is affecting the patient
      2. which stage of the natural history of the illness has been reached
      3. what complications has accompanied the disease
      4. how the patient has responded to the disease

The clinician categorizes his/her patient according to possible risks, severity of illness, stage of development and therefore prognosis. Categorization in turn allows the clinician to choose the right pathway and start an appropriate care plan. It is also a determinant of applicability, availability, timeliness and cost effectiveness. Grading and scoring systems for various diseases have been developed and tested.


Investigation and treatment modalities, however efficacious, have limitations such as unwanted side effects and interactions. They may not be effective in certain situations or when prerequisites are not met. Care providers need to be reminded of these indications and contraindications as part of the decision-making process.


SOPs are often criticized for being rigid and didactic. In fact, by offering different directions and paths, care pathways and care plans offer alternatives in managing a patient based on various valid criteria. SOPs and the corresponding Care plans are designed to suit different anticipated scenarios (see below). Where there is a choice of methods or material without major difference in effectiveness or safety, the care provider is given an option to choose one based on being the best suited or available. Indeed, the care provider may choose to modify  procedures and plans as long as these do not deviate from core policies and  the variance (intentional or otherwise) should be noted.


Care plans are basically  packages of tasks bundled together, arranged and sequenced according to work flows defined by the Care Pathways. The overall care plan provides direction to the clinician on tasks to be performed for a patient from the beginning to the end of the care episode. It is then further broken up into sections for various phases of the care. These are more detailed plans meant to be used at the point of care.

In current practice and literature there are many conceptions and forms that are called ‘Care Plans’. The more popular types are discussed below and an alternative approach is proposed.

Current Use of Care Plans

The Care Plans being advocated and used now are varied. Some models are very detailed and incorporate nearly all care processes. Others have minimal content. The three basic models are discussed below.

Model A

In this fairly popular model, the content includes:

  • results of prior assessment and diagnosis
  • the rationale for the plan
  • expected outcome
  • the theoretical rationale for the plan
  • the expected outcome
  • the documentation of the results of assessment, interventions and  the actual outcome is deemed to be part of the plan.

An example such a Care Plan is given below:

Care Plan for a Patient with Diarrhoea

downloaded from
downloaded from

This model while useful for educationalpurposes is not suitable for practical use.

Model B

More commonly used is a less complicated model where the nursing diagnosis and the corresponding planned interventions (tasks to be performed) are indicated as instructions. Again, the findings of evaluation are expected to be written as part of the plan.

Taken from
Taken from

Model C

In this approach, the plan is part of the SOAP(IE) method of documentation of clinical activities. The ‘Plan’ lies between the Problem Identification step (termed as ‘Assessment’) and actual Intervention. The plan therefore is placed where it naturally fits in the sequence of the clinical care processes.

Taken and modified from
Taken and modified from

Findings and results are then recorded as ‘Evaluation’.

Taken from
Taken from

Lessons Learned from Currently Advocated Plans

In Model A and B, it is obvious that the rationale and the documentation of task performance plus their results/ findings are not elements of a plan. Despite this, they are included because care providers (especially their supervisors) want to see them at one place within the medical / nursing record. This requirement is also the reason why the plan is structured as a table or matrix. However, the choice of this layout leads to unwieldy Care Plans that are cumbersome and confusing to use because of the limitation in the amount of information that can be included in the many narrow columns. Again, despite the use of a matrix, it is also often mistakenly called Care Pathways.

Model C is a logical way of documenting the plan together with other clinical findings. Planning should not be dissociated from other clinical care processes. However, this method is considered inadequate for two main reasons i.e.:

  • the basis for the plan, and the results/outcome are not easily read from one source (a table is preferred)
  • it seems to be ad hoc and not conforming to a standardized prescribed plan

Since documenting actions and findings in a chronological order is a legal requirement, the wish to present the plan as a  table means that nurses have to transcribe (duplicate) what they have written in the medical record into a separate plan. This duplication of effort is the main grouse cited against current care plans.


Based on the lessons learned from the Care Plans in use up to now, it can be deduced that there are two different functions of the Care Plan, facilitated by two different entities i.e.:

  • Reference Care Plan ( a document which acts as a guide)
  • Actual Care Plan (steps to be taken to care for the particular patient)


The Reference Care Plan is a guide that contains the following :

  1. A title defining the service to be given
  2. The intended objective and expected outcome
  3. Lists of tasks to be performed arranged in segments, grouped according to the purpose of the clinical care processes to be performed. The segments or groups include:

The title is a very concise statement indicating the patient type, the diagnosis or indication and the context such as the phase of care, the service delivery setting where the service is to be given (inpatient, outpatient and day care) and the type visit or encounter.

The title of the Care Plan indicates that it is designed for the specific disease or health problem and for a particular phase.  The model plan is generic in application. Conversion of such plans is done when the actual care of an individual patient is provided.

The intended objective and expected outcome is precisely indicated. These may be the expected outcome, treatment end points the degree of restoration or amelioration of the disrupted quality of life (ability to work, enjoy leisure, attend school and perform daily life activities) and avoidance of side effects. Details such as targets, limits and standards are understood by reference to the SOP.

The list of tasks are grouped into functional categories i.e.:

  1. Administrative tasks (Admission, Referrals, Transfer and Discharge, visit registration, follow up appointment, referral and discontinuation of visits.)
  2. Clinical Data Gathering Tasks  (Clerking or Assessment, Progress reviews)
  3. Investigations
  4. Monitoring tasks
  5. Treatment divided further based on modalities such as therapeutic procedures, medication to be supplied or administered, blood product supply and transfusion


The Reference Care Plan is a guide that contains the following :

  1. A title defining the service to be given
  2. The intended objective and expected outcome
  3. Lists of tasks to be performed arranged in segments, grouped according to the purpose of the clinical care processes to be performed. The segments or groups include:

The title is a very concise statement indicating the patient type, the diagnosis or indication and the the context such as the phase of care, the service delivery setting where the service is to be given (inpatient, outpatient and day care) and the type visit or encounter.

The first entity is a generic plan provided as a guide to care providers to develop the second entity. If the guide is on paper (e.g. a booklet), the provider may transcribe parts of it on the case notes (paper record). If it is made available on a personal computer, then the guide can be copy-pasted and modified before being printed. The printed copy is then incorporated as part of the medical record. This reduces the extra work.The Actual Care Plan is a statement of intent delineating the objectives (outcome) and the intended sets of tasks to be performed. The record of events, tasks performed and outcome reached should not be recorded together with the plan. Instead the results obtained are documented as progress review notes, monitoring charts, procedure records, findings, outcome etc. In a completely computerized system, the issue of the need to replicate data entry does not arise because the reference plan can be accessed from a central repository as and when need. Computer software can be used to convert prescribed plans into actual plans and then into tasks to be executed. Data regarding compliance and outcome can be entered and stored in a database it can be retrieved and displayed as a report.
In this proposal, the details in the conventional Care Plan is made available in the SOP. The Care Plan itself takes on the characteristics and functions of a Work Schedule or Action Plan.

From SOP to Care Plan

Relationship Between SOP, Reference Care Plan and Actual Care Plan

 Changes in Service Characteristics with the Context of Care

The other issue, brought into focus by Example C, is the fact that in practice the operational plan is ever-changing, evolving with changes in the patient’s condition and the work process.

Each plan needs to be fashioned according to the pertinent context in response to :

  • the evolving diagnosis: from when the diagnosis is uncertain or provisional (symptom complex, syndrome, disease group) to when the diagnosis is certain definite (specific illness and specific procedure).
  • phase of the workflow
  • other changes e.g.  response to treatment, occurrence of certain complications or events, chosen treatment modality etc.

Catering for the Evolving Diagnosis

The principal criteria defining the need to vary care plans is the evolving nature of diagnosis. It is clear that  separate Care Plans need to be developed for at least two levels based on the clarity of the diagnosis:

  1. The Provisional Diagnosis:
  2. The Definitive Diagnosis:

Symptom complexes & clinical syndromes

incorporating efforts at:

  1. Clarification of diagnosis,
  2. Resuscitation, stabilization
  3. Immediate nursing care

Specific disease entity which give rise to further stages or phases

  1. Phase of initiation and optimization of therapy
  2. Phase of maintenance of therapy, monitoring and re-assessment
  3. Phase of resolution of illness and discontinuation of therapy
Plan According to Diagnosis and Phases of Care

Two Main Phases of the Care Episode Based on Clarity of Diagnosis

Even when the definitive diagnosis is known and a specific care plan is applied, modifications need to be made constantly based on variables such as:

    • changes in the patient’s condition in accordance with the stages of the disease process
    • the workflow or the treatment regimen
    • demands arising from the patient’s response and other effects of therapy

Catering for the Advancing Workflow

Even though the content of care vary continuously with the changes in needs, for practical purposes it is convenient to design Reference Care Plans according to defined periods or phases. The care episode may be divided into phases as illustrated below:

Phase of Care
Phase of Care

Outline of the Care Episode

A care episode is defined as the period within which the management of one particular disease or health problem affecting a patient takes place i.e. beginning with the time of first contact with a health care practitioner to resolution of the illness / problem or death of the patient. In that episode, the patient may make several visits and during each visit, he or she may experience encounters with many health care providers and may experience or be subjected to many care events. Conceptually, patient care is provided in phases corresponding to the sequence of processes (workflow) described in the article on clinical work processes.

Discrete Care Plans for Different Phases

Care plans can be designed for each phase of care. During each phase, the patient makes a certain number visits to the health care facility. The number and type of visit depends on the nature of the illness. Also depending on the patient’s response, the care provider may add or reduce the number of visits. The phases of care of both acute and also chronic diseases can be categorized into:

  1. Phase of diagnosis, stabilization and immediate care
  2. Phase of initiation and optimization of therapy
  3. Phase of maintenance of therapy, monitoring and re-assessment
  4. Phase of resolution of illness and discontinuation of therapy

Catering for the other Changes

Care plans also need to vary with other changes including:

  • response to treatment,
  • occurrence of certain complications or events
  • chosen treatment modality etc.

The choice of alternative plans or modifications of existing  plans is at the discretion of care providers

For patient’s receiving acute care (usually in the inpatient setting), the actual plan need to reviewed almost daily or more frequently depending on the nature of the illness and the treatment modality. In the management of chronic illness the changeover of plans depends on whether desired objectives are met.  Plans for patients on outpatient care are usually modified during a visit except in situations where patients or their carers are empowered to make their own decisions. Plans for various phases are elaborated further below.


The SOP describes the theoretical basis for the selection of approaches, paths and methods besides providing the essential knowledge and instructions to provide care. This degree of detail means that it has be to studied conscientiously to be understood. It is therefore good for staff orientation and training or as a reference source when in doubt. As discussed earlier, the Care Plan is an integral part of the SOP. When using a Care Plan it is assumed that the care provider is conversant with the considerations already detailed out in the SOP. The theoretical rationale and detailed objectives and methods need not be repeated in detail but summarized in the Care Plan. However at the point of care, a more practical guide that is concise and precise  is required. This is provided by Reference Care Plans.

The Reference Care Plan is in three parts:

  • the title
  • list of tasks
  • expected outcome

The title is a concise statement that indicates the scope, purpose and context of the use of the plan. The rest of the plan consists mainly of list of all tasks to be carried out in the care the patient.

 Example: Reference Care Plan for Initial Phase of Acute Coronary Syndrome

Care Plan Table
Reference Care Plan Table


Care plans derived from the SOP remains as a reference document until it is converted into an actual plan by customizing it for the individual patient. The actual care plan is a specific integrated plan that will cater the needs of an individual patient. Customization is required because due consideration need to be given to two main factors:

  • the variant of the  disease affecting the patient
  • the patient’s response to the disease, illness or health problem

To a large extent the differences due to the latter, is contributed by his/her pre-morbid health status, physiological condition and psychological make up. Furthermore, each patient may have different concurrent or pre-existing problems including chronic illness.

The Actual Care Plan is basically a work schedule made up of tasks grouped according to functions. In a paper-based information system, the care provider  responsible for a particular function may write their own schedule with their own notes in the medical record. For example doctors may write their planned tasks in the medical notes. Nurses my write the Nursing Care Plan together with other entries in the Nursing Notes part while rehabilitation therapists, optometrists and audiologists and other allied health professionals may write their own plan in their respective sections in the medical record. Whatever is recorded  is the actual plan and becomes part of the medical record.

In a fully computerized Hospital Information System, a plan can be chosen by the doctor in charge (or any other health professional assigned as the primary provider). It will then trigger Care Sets (Order sets, care bundle) for various other the designated care providers of the functional group who will then modify these sets of planned tasks (orders). These allow the care provider categories freedom to customize their own respective plans. Once confirmed these planned tasks would be recorded as the actual task list. Later when the tasks are performed this fact together with the results emanating from it would be recorded as part of the Medical Record.

Actual Care Plan for Acute Coronary Syndrome


Care Set for Management of Acute Myocardial Infarct

The use of the Care Plan in a computerized Hospital Information System is discussed in the article on Clinical Information System.

 The Relationship Between Stages in the Work Flow and Content of Care Plans

Relationship between Care Process, Documentation and Reference Information


The use of Care Plans in a fully integrated Hospital Information System is discussed in another article.


The essential content of Care Plans are tasks for all or some of the patient care processes that addresses all aspects of the patient’s health problems for both the short-term as well as the long-term. These  pre-determined tasks take the form of  sets of orders often called Order sets otherwise also called Care package, Care-set and Care-bundle. Although care is necessarily continuous and often simultaneous, the content is different for different periods or phases. These periods may or may not coincide with definite moments in time such as a certain day (e.g. day of admission, the morning before surgery, first day post-surgery or day of discharge.  The care provider should be given the choice of modifying the care set by activating or inactivating the orders that it contains.

An order-set is made up of a combination and permutation of orders predetermined for each category of illness. Tasks are performed according to the orders. The care sets will consist of all patient care processes necessary for a defined period. It may also include clinical administration tasks.

The type of orders within an order set would include any or all that is necessary to carry out the patient care processes including:

    1. Administrative tasks (Admission, Referrals, Transfer and Discharge, visit registration, follow up appointment, referral and discontinuation of visits.)
    2. Generation, gathering and collection of data about the patient’s illness and the effect on his/her health.
      • Data collection tasks e.g. Clerking or Assessment using a specific clerking form and Progress reviews guided by various note types.
      • investigations by various techniques,
    3. Analysis and interpretation of data to determine the diagnosis and needs of patients
    4. Planning the case management
    5. Preventive actions,
    6. Treatment using various modalities including therapeutic procedures, medication to be supplied or administered, blood product supply and transfusion
    7. Monitoring and Review of progress of disease status of the patient’s health, effects of treatment
    8. Evaluation of outcome)
    9.  Review of diagnosis and management
    10. Rehabilitation
    11. Patient education
    12. Provision of or advise on nutrition
    13. provider-patient communications (briefing, advice)
    14. Any other therapeutic tasks
    15. Continuation of care or Final disposal of the case

For inpatients, these can be admission, referrals, transfer and discharge. For outpatients, these can be visit registration, follow up appointment, referral and discontinuation of visits.


<style=”text-align: justify;”>Care Schedule 4

Traditionally, the plan for the overall care of a patient is done by the doctor in charge (or any other primary care provider). In a computerized environment, the care plan is predetermined by consensus and executed through Order/Care Sets and can be manually or automatically triggered. From this overall plan, the care providers responsible for each aspect of care may select and activate care plans applicable for the patient. The care provider should be given the choice of modifying the care set by deselecting some of the orders or placing additional orders. All or some of the items listed in a plan/order set can be made mandatory or pre-selected while others can be actively selected or deselected by users.

EXAMPLE Order Set for “Acute Coronary Syndrome”

The care provider retains control of decisions and choices. The plan is a recommendation. Quality control mechanisms such as detection of deviations or variance from the plan, unexpected results and tasks not completed via check lists should be put in place and documented.

Chest trauma

 Division of Duration of Care into Periods

For a particular health problem, the care delivery may be divided into:

  1. Episode
  2. Phases
  3. Visits
  4. Encounters
  5. Tasks or Events
    1. Entire Care Episode
    2. A particular Phase
    3. A particular service

A care episode refers to the whole duration of service provided from beginning to end. It contains the sum of all visits.The division into Phases is conceptual rather than real. The differentiating factor is whether the illness is acute, sub-acute or chronic.Visits are instances when the patient comes to the health care facility. They can be categorized further according to service delivery systems i.e.

  1. Outpatient visit
  2. Emergency visit
  3. Inpatient visit
  4. Day Care visit
  5. Home Care visit
  6. Teleconsultation visit

Visits can also be categorized according to sequence

  1. First
  2. Follow up (FU 1, FU 2, FU 3 etc.)
  3. Final

The number of visits per episode is by nature variable but may be intentionally fixed in a service package. A visit requires one or more identified physical resources such as room/bed within a clinic complex or ward. During the visit, the patient may have one or more encounters with different care providers at the same or different resource. The duration of each encounter is defined as time slots.

Tier 2: Visits and Encounters for each Phase

The progression from one phase to the next need to be decided by the care provider based on the amount and quality of data available, the certainty of diagnosis, the appropriateness of a chosen care plan and the response to therapy. Since the Case Management Plan is an interdisciplinary effort, each care provider has the opportunity to operationalise the part of the plan in their area of expertise. Yet, there should be consultation with other members of the care team. The patient also needs to be aware of the plan, be allowed to make queries and be involved in it.

Care Schedule 2
Division of a Care Episode into Phases

Phase of Diagnosis, Stabilization and Immediate Care

This is the phase of initial contact with a health care provider. The disease process itself may be at an early or later stage of the natural history of the disease, depending on whether the patient seeks treatment early or late.In this phase, the main objective is to determine the diagnosis as accurately and comprehensively as possible. The main tasks are clinical data gathering and diagnostic investigations. At the beginning of this phase, the data available may allow the clinician to determine the diagnosis in terms of symptom complexes or syndromes. Therapy would then be directed towards symptomatic relief, resuscitation if necessary, stabilization and support (physiological, psychological, social and spiritual). Besides the diagnostic investigations, data accumulated through observing and monitoring the patient will help in arriving at a definitive diagnosis. The diagnosis need to be further refined to clarify the variant of disease, severity grade, stage of illness, risk stratification and prognosis.

Phase of Initiation, Re-assessment and Optimization of Therapy

In this phase, the disease entity/entities and accompanying health problems affecting the patient are already established with some certainty. An appropriate definitive management plan (curative, palliative / supportive, rehabilitative) is adopted and implemented. Depending on the disease, the objective of treatment would be to cure the illness, contain it or control it. As such, treatment end points need to be defined and measurements made to determine whether these end-points have been achieved. Optimization is considered achieved when the treatment regimen produces the best possible level of benefit. These factors would determine the choice of management plans including treatment approaches or modalities.(curative, palliative / supportive, rehabilitative) is adopted and implemented. Depending on the disease, the objective of treatment would be to cure the illness, contain it or control it. As such, treatment end points need to be defined and measurements made to determine whether these end-points have been achieved. Optimization is considered achieved when the treatment regimen produces the best possible level of benefit.

Care Schedule 3
Care Schedule

  ⇒ [Back to the Top]

3 thoughts on “Development of Standard Operating Procedures and Care Plans”

Leave a Comment

Fill in your details below or click an icon to log in: Logo

You are commenting using your account. Log Out /  Change )

Google photo

You are commenting using your Google account. Log Out /  Change )

Twitter picture

You are commenting using your Twitter account. Log Out /  Change )

Facebook photo

You are commenting using your Facebook account. Log Out /  Change )

Connecting to %s

This site uses Akismet to reduce spam. Learn how your comment data is processed.

%d bloggers like this: