Development of Standard Operating Procedures and Care Plans IN CLINICAL CARE

Date First Published: January 9, 2015
Date Last Revised: October 7, 2020

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

This article hopes to clarify some of the issues regarding the development and use of standardized plans in the delivery of patient care. I have thought about this issue over many years. This article has taken months to prepare and I have not come to the end of trying to express my understanding the subject fully. It is a complex subject both in breadth and depth and trying to get through this article may be quite daunting. There are repetitions and for some content, details are spread over a few sections. I have tried to write as simply as is possible. I hope you will bear with me and persevere in trying to go through it. The outline below may help in its understanding.

.Subject
1The Need for Formalized Planning in Healthcare
2Adoption of Standard Operating Procedure
3Strategies in Design
Based on:
a. Quality by Design Concept
b. Practice of Evidence-based Medicine
c. Incorporation of the Total Patient Care Concept
4Factors to be Considered in Construction of the SOP/Care Plan
a. Consideration for Variations
b. Factors Contributing to Variations
c. Identification of Needs
d. Diagnosis
e. Patient Profile
f. Care Objectives and Standards
g. Clinical Work Process
h. Phases of Care
i. Workflow
5Conversion of Reference Plan to Actual Plan
6Structure and Content of the SOP/Care Plan
Title.
Care objectives
Description of the Clinical Work Processes
Workflow
Specific Work Instructions
The Work schedule
Guide on documentation
Reference tables
Quality Control Methods
7Examples

INTRODUCTION

When used in manufacturing industries, the SOP describes the plan for producing a product. The product nearly always has specific characteristics (specifications) and rather rigid methods of production. The product of services can also have fairly uniform characteristics and be called service products. In healthcare, while there is a need for uniformity in the way care is delivered, this must be accompanied by efforts to customize and personalize it by taking into consideration the many variations in the characteristics of the problem and the recipient which, when taken together, determines the outcome aimed for.

Currently, the need to regulate health services, streamline health care funding and ensure uniform quality of care is increasingly being realized worldwide. This 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. For example, organizations who provide funds for health care now determine or at least influence, what goes into the management of different types of cases (e.g. by diagnostic related group – DRG) and allocate funds based on the composition of the recipients (Case mix).

Adoption of the Use of Standard Operating Procedures

Obviously, the delivery of patient care is better planned in advance rather than provided in an ad hoc manner. The time has come to relate patient care practices to that of other industries in order to take advantage of innovations in the latter. Within the healthcare community, 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’ or “Care Plan”. For all intends and purposes it can be made to be equivalent to the ‘Standard Operating Procedure (SOP)’ and there is no reason not to call it such.

Clinical services are designed according to the needs of patients. The SOP can be taken to be a detailed plan applicable to the delivery of services 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. As in any other service, the design and planning of clinical care involves translating the needs of recipients (patients) into uniform specifications and standards of both the service delivery itself and more importantly the final outcome of the service.

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 necessary. The term ‘Care Plan’ which has been used in planning patient care has the same purpose, structure and content. If it is more acceptable, it can used in lieu of the term SOP. Henceforth in this discussion, the SOP and Care Plans are deemed to be synonymous. In this discussion, both terms will be used together abbreviated as SOP/Care Plans. In practice either term can be used.

PLANNING AS PART OF THE CARE PROCESS

Planning is part of the series of processes in the delivery of patient care (described in another article). It is a series of thought processes that are then documented. These consist of:

  1. Identifying the case type (service product)
  2. Determining the objectives of care
  3. Deciding on and choosing the approach and method
  4. Deciding on and scheduling the sequence and layout of actions
  5. Ensuring that resources are available to carry out the plan
  6. Assigning responsibilities
  7. Anticipating issues that may arise
  8. Documenting the plan
Planning as part of Patient Care

The plan is then executed and the results are evaluated. It is redrawn if necessary.

Patient Care as a Service Product

It is proposed here that the delivery of a healthcare service product is best described in the form of a Standard Operating Procedure (SOP) which otherwise can be termed as the Care Plan. Both terms refer to the predicted or planned policies and procedures in managing a clinical problem. Although it is common to depict the Care Plan as a table or matrix, this is not the best way to explain it. Tables limit the amount of content and do not show sequence and layout clearly. It is better for the structure and content of patient care plans to be similar to  the SOP used in other industries.

A SOP is meant to be used as the guide to production of a particular item or the delivery of a specific service. Services in healthcare are numerous and diverse. The challenge in healthcare is to define the service for which the SOP/Care Plan is written.

SOP/Care Plan as a DISEASE-SPECIFIC SERVICE DELIVERY PLAN

The care of a patient, usually referred to as a case, is based primarily on the identified diagnosis or health problem. Therefore, the logical approach would be to design of SOP/Care Plans for the provision of services for patient groups (case types) affected by the same disease. That service can be called a service product.
Even though diseases are diverse, their classification and names have been standardized e.g. as in ICD-10 Classification of diseases and SNOMED.

However, even for a particular case, the diagnosis changes as as more information about it is obtained, The method would be to work from the general to the specific. The diagnosis is rather general at the beginning, (identified as Symptom complex, Syndrome or belonging to a Diagnostic related group) but later becomes more specific (identified by named diseases and their sub-types)

When diagnosed as a symptom complex, clinical syndrome, or belonging to a Diagnostic related group, patients share common problems and be given correspondingly similar care. SOP/Care Plans must be created for the care of patients belonging to these groups.
Subsequently, SOP/Care Plans should be developed for specific diseases. On top of that, variations of the SOP/Care Plans will have to be developed for sub-types of the disease based on pathological grading, urgency, stage at presentation, severity level, presence of complications and etc. Where there are distinct variations, services for these sub-types can be considered as essentially different service products. A separate sub-set of the SOP/Care Plan should be created for each one of the sub-type.
If the patient has more than one health problem, then the combination of various plans would be required.

SOP/Care Plans Matched against Corresponding Service Products

USE OF STANDARD OPERATING PROCEDURES IN PATIENT CARE

The design of SOP/Care Plans in patient care requires the use of many tools. Their content and structure should have the following characteristics:

  1. Describe an accepted way of providing care for a case
  2. Clarify objectives of care (expected outcome, therapeutic end points)
  3. Identify variations in patient needs and provide alternatives (Care pathway, Decision making steps)
  4. Outline the layout and sequence of tasks (Workflow)
  5. Allocate responsibilities (organization of the care team, Work schedule, Task lists)
  6. Define the control limits of both processes and outcome and incorporate methods to ensure compliance with them (built-in Quality control),

With training, the nomenclature and conventions used in operations management in other industries can be understood and adopted for use by clinicians, just as effectively. This would allow people in other fields such as information technology, accounting and management to understand clinical care processes. The documents and their parts making up the SOP/Care Plan for a specific case type are discussed below.

BENEFITS OF THE USE OF STANDARD OPERATING PROCEDURES / CARE PLANS

Benefits for the Care Provider

For the care provider, formalized planning of care provides many advantages including:

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

The SOP/Care Plan acts as the guide for the care provider in the care of his/her patients by providing the essential knowledge on the selection of approaches, paths, methods and standards. It is therefore a good tool for staff orientation and training or as a reference source when in doubt. The degree of detail within it means that it has be to studied conscientiously to be understood. When using a SOP/Care Plan, it is assumed that the care provider is conversant with its purpose, content and structure. The theoretical rationale and detailed objectives and methods need not be presented in detail but referred to or summarized. In addition when performing specific tasks, more practical guides that are precise and didactic are required. These are provided as reference documents such as Work instructions and Reference tables.

Benefits from an Operations Management Perspective

From an Operations Management perspective, a documented SOP/Care Plan is useful 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

Benefits for the Unit or Department Manager

From a service or departmental managerial perspective, the use of SOP/Care Plans can lead to the following:

  1. Promote uniformity and standardization
  2. Render a degree of predictability in the supply of various resources
  3. Encourage uniformity and standardization
  4. Act as a basis for quality measurement and control
  5. Encourage equitable care and remove bias
  6. Improve staff knowledge, skills, attitude and behaviour

Benefits from the Strategic Management Perspective

From the perspective of strategic management, SOP/Care Plans 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 SOP/Care Plans, the current and earlier practices cannot be compared and it would not be possible to distinguish any improvement.

Therefore, an SOP/Care Plan for the care of a patient with a defined disease condition or health problem (a service product) confers benefits for health care providers and health services managers alike. In the end, patients would greatly benefit from care that is made consistent and controlled.

Overcoming Doubts about Use of SOP/Care Plans

Despite these benefits, there are apprehensions, among clinicians and managers alike, that use of standardized plans will lead to

  1. people following them blindly (“cook-book” medicine)
  2. loss of clinical freedom.

These concerns are valid and should be addressed by building in variations, exceptions, alternatives and contingency plans into their design. It must be stressed that the SOP/Care Plan, when first designed, is a reference document to be used as a guide. It has to be converted to actual plans with active input from the healthcare provider in charge of the case him/herself before being applied to actual care.

DESIGN OF THE SOP/CARE PLAN

SOP/Care Plans are basically packages of tasks bundled together, arranged and sequenced according to the clinical workflow. The overall 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, visits and encounters within the episode.
In current practice and literature, there are many conceptions and formats that are called ‘Care Plans’ discussed in an earlier article. There is a need to develop a more effective alternative approach as proposed here.

GUIDING PHILOSOPHIES AND STRATEGIES IN THE DESIGN OF THE SOP/CARE PLAN

Some of the philosophy, principles and strategies that can guide the development of a SOP/Care Plan for patient care include:

  1. Application of modern management concepts and techniques
  2. Ensuring that the plan is feasible (usable) and acceptable to users
  3. Based on evidence-based medicine
  4. Imbued with the Total Patient Care concept (Holistic Care taking into consideration all needs of the patient)
  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
  9. Follow a two step process i.e. choosing an appropriate plan to be used as a reference and using it to create the plan which will be used in the actual care of the patient.

These principles and strategies are deliberated further below.

Application of Modern Management Concepts and Techniques

Strategy Based on “Quality by Design” Concepts

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 and others). These consist of a systematic sequence of steps i.e.:

  1. Identification of primary needs of the client (the health problem, diagnosis)
  2. Identification of additional / special 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 various service providers
  9. Identifying the monitoring and control measures (Monitoring, Review and Evaluation, Quality Control)
  10. Providing the means for data documentation (Clinical Documentation, Forms, Charts)
  11. Catering for variations, exceptions and contingencies by providing alternatives
  12. Anticipating possible errors of omission or commission, their prevention and damage control

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

Use of the “PDCA CYCLE” During Development

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, achievement of an outcome that conforms to the desired 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

Once developed, the plans will act as the standard to be followed by everyone who manages a patient suffering from the disease, syndrome or symptom complex, in the facilities within the organization. This approach to standardization should not, in any way, discourage care providers from altering practices in peculiar situations and for unique demands. Allowance for variations may be written into the plans.
Once adopted and put into practice there is a need for audits to be performed to monitor conformance and to determine its effectiveness. Development of plans is a never ending continuous learning process.

PRACTICE OF EVIDENCE-BASED MEDICINE

The care provider is confronted with multiple 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/Care Plans 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:

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

Evidence-based Practice of Medicine

The design of SOP/Care Plans are made easier because currently there are already generic plans designed in advance by experts (e.g. professional bodies) who have thorough understanding of clinical care processes and the modalities available for investigations, treatment and monitoring. These generic plans take the form of Practice Guidelines. Based on these, more precise plans for more specific disease and patient groups can be deigned as SOP/Care Plans.

Transformation of Guidelines into SOP/Care Plan

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, effective, usable and acceptable before being adopted and endorsed by the people in charge (e.g. Clinical Services Committee, Medical Advisory Committee, Clinical Governance Committee and the Hospital Management). As such, the SOP/Care Plan is valid for use within the organization that develops it.

For the SOP/Care Plan to remain valid it has to be continually updated. The best way is to audit the SOP/Care Plan both in terms of the adherence to them and also their effectiveness in achieving intended objectives. Findings from the audit is then used to improve conformance as well as to rectify the SOP/Care Plan itself.

INCORPORATION OF THE TOTAL PATIENT CARE CONCEPT (HOLISTIC CARE)

The SOP/Care Plans need to be comprehensive, cohesive and orderly. A comprehensive patient care plan based on the philosophy of Total Patient Care or holistic care to patient care should be adopted. and This approach addresses all aspects of the patient’s health issues for both the short-term as well as the long-term. The design of such SOP/Care Plans 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/Care Plan 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”).

Involvement all relevant health care professionals encourages each of them to:

  1. be interested in the overall well-being of the patient,
  2. understand the entire care plan,
  3. be able to respond to a patient’s query regarding each aspect of his/her care
  4. contribute to the success of the overall plan, wherever possible

Function of the SOP/CARE PLAN

Each SOP/Care Plan describes the plan for providing a specific service product i.e. the delivery of service for patients with a particular disease or health problem. It should have enough breadth and depth to cater for the following functions:

  1. explain the theoretical basis for content and layout of care
  2. provide the guide to policies, procedures and decision making
  3. provide the essential knowledge and instructions to help the care provider give safe, effective and appropriate care.

Hence, the SOP/Care Plans can act as reference document for:

  1. carrying out work processes
  2. training
  3. use as the standard for comparing actual performance with what is expected

Composition of the SOP/CARE PLAN

SOP/Care Plans are made up of tasks to be performed to produce a product or to offer a service (a service product) and the policies that govern them. For them to be standardized, they need to be documented in a structured way. There should be an SOP/Care Plan for every service product.

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.

DIFFERENCES BETWEEN IMPLEMENTING SOP IN CLINICAL CARE AS COMPARED TO OTHER SERVICES

In manufacturing industries the products have well defined specifications and so also are the input and processes used. In service delivery, the service product has specifications that are not so strictly defined and often there is a need for the delivery to be customized and personalized to fit the special needs of the recipient. This need is more acute in healthcare services.

As such, the main SOP/Care Plan can be a general plan for a typical disease, Variations in the disease itself can be anticipated and plans for its care can be written as extensions to this main SOP/Care Plans. When the variation is major a separate SOP/Care Plan need to be written. In addition, another step, i.e. the conversion to the plan that will be used for actual care, is necessary.

Conversion of SOP/Care Plans for Use on an Individual Patient

Varied Nature of Clinical Patient Care as Service Products

To clinicians, the ‘care’ or ‘the management of a patient’ is the provision of the entire service or care for a certain patient according to his/her needs which are determined largely on the identified diagnosis or health problem. The title of the reference SOP/Care Plan should show that it is designed for the ‘care’ of this specific disease or health problem. As such, the Service product consists of a well-defined set of services to be provided for a typical patient (case) who has an episode of a specific illness. Yet it is, to a certain extent, still generic and would need customization, by additions or omissions, when it is used as the Actual SOP/Care Plan in the actual care of an individual patient.

The needs of each patient varies quite significantly depending on many factors. Thus personalization i.e. variation of the care given to a particular patient must be done not only at the beginning of the service but also throughout the service delivery period because the needs often varies as the care and the disease progresses. Hence, it is necessary to modify the original SOP/Care Plan, from time to time (throughout the phases of care) during actual implementation.

Concept of Reference vs Actual SOP/Care Plan

In most industries, in order to produce products that are consistent, the SOP is used directly and strictly by all workers with little or no modification. This approach is not advisable for services in healthcare. Standard SOP/Care Plans cannot satisfy a patient’s needs fully. Besides the attention to the illness and its effects, care plans also need to have consideration for the general needs of the patient (i.e. a sick person). These are often unique.

Two Step Process in Implementing SOP/Care Plan

Therefore, it is essential that planning of patient care follow a two step process i.e. choosing an appropriate plan (termed as the Reference plan) and using it to create the plan which will be used in the actual care of the patient (termed as the Actual plan). The Reference Plan is transformed into an Actual plan or in other words, the Actual Plan is derived from the Reference Plan.

When using a SOP/Care plan as a guide, the planning process is done in two major steps i.e.:

  1. Choosing the appropriate Reference  (Model) Plan from the library of previously prepared care plans
  2. Converting the chosen reference plan into an Actual (Operations) Plan by customizing it to cater for the special needs of the patient

In practice, the Actual plan is the definite plan and is documented as part of the Medical Record. Constructing the Actual plan is the responsibility of the clinician(s) looking after the patient.

The Reference Plan

At the beginning, the efforts must be made within the healthcare facility to design standardized plans that are generic in nature i.e. applicable to typical patients with a typical disease condition. All such plans should be made available (by whatever means) as a properly indexed comprehensive library. The Reference plan for a particular case is selected from this library.
After choosing a plan that matches the needs of the individual patient, the care provider uses his/her own special knowledge, skills and discretion to modify it. Patient care plans need to be individualized and customized by the care provider by putting together all available information, choosing the most relevant subset of the plans, combining them and adding or omitting certain options. The resultant plan is then the Actual Care Plan to be implemented.

Building Reference Plans for Alternatives, Variations, Options and Contingencies

Care Plans are designed mainly on the basis of diagnosis. At the initial phase of care, the diagnosis is broad or general. Subsequently, as more information is available, a different diagnosis may be made. Hence, it is not good enough to continue using the SOP/Care Plan based on the initial diagnosis. If the diagnosis differs significantly a more appropriate SOP/Care Plan must be chosen as a replacement.

During the course of patient care, the amount and clarity of information available to the care provider increases and the diagnosis becomes more accurate or new problems emerge. If the change is minor then the plan is revised accordingly. If these changes are significant, another more relevant plan or sub-type of it is chosen. The SOP/Care plans must be changed to reflect the type of care required for any change in diagnosis. Hence, appropriate reference plans need to be built and made available for:

  1. the variant of the disease (pathological grade, clinical onset)
  2. the stage of its natural history (early, late)
  3. severity grading
  4. patient profile / category (age, gender, risk factors, confounding factors)

Reference SOP/Care Plans are constructed, compiled, indexed and kept as a set of reference documents (a properly indexed library of those documents referred to in industry as the Work Procedure Manual) and made accessible to care providers. Each document consists of various components that address various aspects of care (written as sections and paragraphs). The components would be like those in SOPs already in use in other industries as will be outlined below.

If the patient has more than one health problem, then the application of a combination/amalgamation of the generic plans into one actual plan would be necessary (as depicted below).

Amalgamation of Generic Plans into a Single Actual Plan for an Patient with Multiple Problems

Technique of Converting Reference Plans into Actual Plans

The chosen SOP/Care Plan becomes the preliminary plan that can be customized by adding or removing certain elements before being confirmed as the actual plan and used.
If the Reference plan is made available on paper (e.g. a booklet or manual), the provider may transcribe (rewrite) parts of it on the case notes (paper medical record).
If it is provided on a personal computer, then the plan can be copy-pasted and modified before being printed. The printed copy is then incorporated as part of the paper medical record. The plan is still on paper but this reduces the extra work of rewriting/transcribing it.
In a computerized information system (Hospital Information System, Clinical Information System), various SOP/Care Plan documents can be given as reference documents as part of the application. Care providers can select the relevant plan through a search mechanism or from a drop down menu. Rationalization of the plan e.g. omitting redundancies can be done automatically. The system can also incorporate means of suggesting an appropriate SOP/Care Plan based on the documented diagnosis and other parameters. There is a wider range of possibilities of manipulating the document when a computerized system is used. For example, if the patient requires the use of multiple plans the combination and permutation can be done based on artificial intelligence.

Choosing a Model Plan from a Library of Reference Care Plans

The SOP/Care plans remains as a reference document until it is converted into an actual plan by customizing it for the individual patient. The finalized plan should be a specific integrated plan that will cater for all the needs of the patient.

Actual Plans

The Actual Care Plan is a statement of intent listing out the intended sets of tasks to be performed and their objectives (expected results or outcome). Planning is regarded as an essential clinical process and the plan is recorded as a separate item in the medical record. The record of events, tasks performed and outcome reached should not be put together with the plan because these occur after the planning process following a different time sequence i.e. when transactions actually happen. Instead, the execution of the plan (the treatment given), and the results obtained are documented, as and when the processes are performed, in the form of progress review notes, monitoring charts, procedure records, findings, outcome documentation and etc.
In a completely computerized system, the issue of the need to replicate data entry does not arise because the plan (both reference and actual) can be accessed from a central repository or a section within the application as and when needed. Computer software can be used to convert prescribed plans into actual plans and then into orders/tasks to be executed (task lists). Data regarding task performance and results can be entered and stored in a database. The information can be retrieved, analyzed and displayed as a report on conformance to plans and the outcome of care.

Plans are also modified or revised if various other emerging needs appear. If pre-designed plans are not available, then the care provider needs to devise the various plans him/herself. Therefore, to minimize this need, it would be helpful if a comprehensive range of SOP/Care Plans that cater for particular scenarios in the care of a patient are already designed and made available.

The actual plan is then communicated to other care providers by documenting it in the medical record or the Clinical Information System (under the section for Plan). The details of the plan for the entire care episode is described in the SOP/Care Plan which should be referred to rather than copied. In the medical record, a statement as to which SOP/Care Plan has been chosen is indicated e.g. “to treat patient as case of Acute Coronary Syndrome”.
Since the care of a patient is a multidisciplinary effort, each care provider has the opportunity to put into effect (operationalize) the part of the actual plan in their area of expertise during their encounter with the patient. They may modify their portion of the Actual plans when needs arise. 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. Changes to plans (variance) must be documented.

Factors to be Considered in Developing SOP/Care Plans

The following factors need to be considered in the development of SOP/Care Plans:

The structure and content of the SOP/Care Plan document is written in accordance with the factors listed above.

  1. Identification of the Needs of the Patient Identification of the Needs of the Patient
    1. Identifying the case type (Primary Diagnosis) Disease complexity (type, pathological grade)
      1. Severity Level
      2. Stage of the disease
      3. Effects and complications of the disease
    2. Other needs arising from other Health Problems (preexisting disease, pre-morbid health status)
    3. Care Objectives
      1. Cure
      1. Containment (by 2O or 3O Prevention)
      2. Palliation
  2. Policies and Procedures Clinical Care Processes
    1. Information gathering
    2. Deriving conclusions
    3. Planning
    4. Execution
    5. Review/Evaluation (of diagnosis, objectives and plan)
    6. Legal, professional and ethical considerations
  3. Phases of Care Changes in the certainty and comprehensiveness of the diagnosis
    1. Progress of the disease along its natural history
    2. Stage of the workflow
    3. Other emerging issues
  4. Guide to Making Decisions
  5. References as aid to performing tasks or making decisions
  6. Quality Control Methods Methods to Ensure Conformance
    1. Preventive measures
    2. Quality Measurement
    3. Comparison with Standards
    4. Detection of non-Conformance
    5. Rectification and Damage control

IDENTIFICATION OF PRIMARY NEEDS OF THE CLIENT

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 about the patient, analyze them and identify his/her 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. Besides the main illness the patient often has secondary needs arising from concurrent illness, preexisting illnesses, disabilities and other health problems. These should also be addressed.

In other industries the product of manufacturing or outcome of service delivery are well defined and so also are the input (human resource, material, machines) and the processes used. This is not so in healthcare. While care can be made uniform based on the patient’s disease, the needs of patient varies quite significantly depending on many factors. Even if it would seem that there as many service products as there are diseases, these would have to be broken further into more specific sub-types.

DESIGN BASED ON DIAGNOSIS OF PRESENT ILLNESS

The present illness is the primary consideration in formulating the service to be given to the patient (the service product). However, the nature of the Present Illness is not immediately apparent at the beginning of patient care. During the course of care, the amount and clarity of information available to the care provider increases and the diagnosis of the present illness becomes clearer or additional problems emerge. If these changes are significant, another more relevant plan is chosen. If the change is minor then the plan is revised or amended accordingly.

The Working Diagnosis as the Basis for Selecting a Plan

Clinicians used the term Working diagnosis to denote the diagnosis based on which the care is planned at the current time. At any point during care, the SOP/Care Plan must be based on this Working Diagnosis. This diagnosis becomes more accurate as the amount and quality of data available to the clinician. It can be a broad or general diagnosis, a presumptive diagnosis or a definite diagnosis.

This also means that care must be instituted even when the definite diagnosis has not been identified with certainty. Therefore, plans for care of a particular patient need to change according to the changing levels of accuracy of the diagnosis.


Planning When the Diagnosis Is Uncertain

At the initial phase when only data gathered through interview, examination and simple tests are available, a broad or general diagnosis may be made. This makes it necessary to build SOP/Care Plans for diagnosis expressed as:

  1. symptom complex,
  2. a clinical syndrome or
  3. a diagnostic related group.

As more investigations and monitoring data are made available a more specific diagnosis is possible. There are instances when not all the criteria for a definite diagnosis are available. The care provider may decide to use the most likely diagnosis as the basis for a SOP/Care Plan. The diagnosis is then called the Presumptive diagnosis. The care provider must be aware constantly that this is the case and be ready to change the plan if further evidence points to a different diagnosis. Even when a diagnosis is deemed to be definite (all the criteria to support it are satisfied), the he/she needs to identify the variant (sub-type) of the disease and the stage in its natural history. SOP/Care plans must be designed not only for specific diseases but also their variants. 

Hence, categorization, staging, pathological grading, severity level and risk stratification are important prerequisites before objectives of care are determined and the right SOP/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. A discussion on Diagnosis is available in another article.

Care Plan for Symptom Complexes, Syndromes and Diagnostic Related Groups

The SOP/Care plan for symptom complexes, syndromes and diagnostic related groups are aimed at:

  1. clarifying the diagnosis through diagnostic investigations,
  2. providing treatment for symptom relief
  3. providing supportive therapy
  4. establishing monitoring and observation routines

At the completion of these activities, a more definite diagnosis is made and the patient profile is known. Then, an appropriate SOP/Care plan for a specific disease can be chosen.

Care Plans for an Identified Disease

A SOP/Care Plan is designed and written for a specific service product. While the description of a disease (as in a textbook) can be in general terms encompassing all presentations of it, the service product must have clear specifications and limits as to its application. SOP/Care Plans is written for the main disease only if has very minor variations in its presentation. Otherwise, as a rule, they would be written for a disease sub-type.

For example, Type 1 (Juvenile onset) Diabetes and Type 2 (Adult onset) Diabetes has dissimilar characteristics requiring two separate SOP/Care Plans. It is not appropriate to write one for Diabetes.

Quite often the diagnosis made refers to an entity that is a group of diseases rather than a distinct disease. For example, Pneumoniae refers to a group of diseases of infection of the lung consisting of Lobar pneumonia, Brochopneumonia, Atypical pneumonia and variants related to the causative microorganism. As such Pneumonia is a diagnostic related group (DRG) rather than a specific disease. A SOP/Care plan has to be written for this DRG i.e. initial care of Pneumonia in general but specific SOP/Care Plans is required for its variants when identified later.
Sometimes, despite various efforts, the definite diagnosis cannot be ascertained. Then, either the provisional diagnosis or the closest diagnosis that can be reached (the Working diagnosis or Presumptive diagnosis) is used to select the SOP/Care Plan.. Later as care proceeds, further developments in the disease process (symptoms, signs, physiological changes) or findings after treatment (e.g. surgery) will lead to a Definite diagnosis warranting a change in the plan.

Disease Sub-types and Corresponding Subset of SOP/Care Plans

When the patient’s diagnosis is identified as a specific disease entity or a variant of it, the care that is provided for it would be the service product. For better understanding of the relationship variants and the SOP/Care Plan associated wit it, the following terms are used in this discussion:

  1. the variants of the disease can be called the sub-types of it
  2. the different plans for the care of patients with these variants can be called the subsets of the SOP/Care Plan.

Categorization of 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. As such, grading and scoring systems for various diseases should be adopted for each disease and the care plan should have variations for different severity levels, stages and grades.

Variants of the disease are determined by:

  1. the pathological grade (virulence of causative organisms, tumour cell type, degree of differentiation of neoplasms)
  2. clinical onset (acute, sub-acute, chronic)
  3. the stage at presentation relative to its natural history (early, late)
  4. severity grading (mild, moderate, severe or extent of involvement)
  5. patient profile / category (age, gender, risk factors, confounding factors)
Sub-Types of SOP/Care Plan Corresponding to Variations in Patient Profile and Disease Pattern

Designing and Writing SOP/Care Plans for Variants of the Disease

SOPs are often criticized for being rigid and didactic. In fact, by offering different directions and paths, the SOP/Care Plans offer alternatives in managing a patient based on various valid criteria. SOPs /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.

Creating alternative subsets of a SOP/Care Plan catering for variants or sub-types of the disease is a challenge. They can be designed and documented in two ways:

  1. as alternative segments to the main plan where the variation of the care of the various sub-types is slight
  2. as a separate SOP/Care Plan, if there is a distinct difference in the care for the each sub-type of the disease

The concept of sub-types of the disease and corresponding sub-sets of SOP/Care Plans is depicted below.

Sub-types of Service Product and Corresponding Sub-sets of SOP/Care Plans

Expressing Variations in Care Either as Alternative Segments in the SOP/Care Plan or as Separate Documents

Multilevel numbering of the SOP/Care Plans is a good way of indexing the documents.

When the variation in case type and their care is slight there is no necessity to write separate SOP/Care Plans. Instead the difference in the care is expressed as alternatives in identified segments in the document. For example, Bronchial Asthma is categorized based on variation in acuity of onset into Acute and Chronic types. The two categories have very different presentations and approach to treatment. As such, there is no value in having a SOP/Care Plan for Bronchial Asthma per se. However, separate SOP/Care Plans have to be designed and written for its two categories. Separate SOP/Care Plan are also needed for care of Bronchial Asthma in children.
Each of the categories (acute or chronic) has further sub-types based on severity. The differences of their care is mainly in the treatment. As such this variation in care of the disease sub-types is written as alternative segments/paragraphs (with headings) as shown below:

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Sub-types of Service Product and Corresponding Sub-sets of SOP/Care Plans Plans foe Care of Adult Patients with Bronchial Asthma

Taking the Patient Biological Profile into Consideration

For many diseases, the presentation and the management is different for the paediatric vs the adult age group. Separate SOP/Care Plan must be designed for them. The same may be true if there is major variation in the disease and its treatment due to gender (e.g. Urinary Incontinence). Variation in the care when it happens in the elderly would probably require an addendum rather than a separate plan.</


 

Taking the Patients Underlying Health Status into Consideration

If complete care is to be given, consideration should be given not only to the current illness but also health status before the illness began. It would be uncommon for separate Reference plans to be necessary for these circumstances but certainly the Actual Plan needs modification taking the following factors into consideration:

  1. The general health in terms of nutrition, physical ability, physiological functions and psycho-social status
  2. The existence of Concurrent, Preexisting and Unresolved Previous illnesses
  3. The existence of disabilities, handicaps, deformities (congenital or acquired, temporary or permanent)

The plan must therefore incorporate considerations of the Total Patient Care Concept mentioned previously.

INFLUENCE OF CARE OBJECTIVES AND STANDARDS ON THE DESIGN

The objectives of the service provided (care of the patient) should be determined and stated at the outset in the SOP/Care Plan. In some instances the objectives are also determined for every phase of patient care. Indeed the objective for any intervention need to be known.
At the start of the care episode the diagnosis is often uncertain. Yet in the interim, care with appropriate objectives is offered to the patient. As the disease and the care progresses, the diagnosis becomes more certain, more definitive treatment is given and the objectives can be stated more clearly.

There are three main categories of treatment goals depending on the potential for altering the progress of the disease i.e. :

  1. Cure of the disease
  2. Containment (by 2O or 3O Prevention), Support and Relief
  3. Palliation of symptoms and of disturbed function

The objectives of care influence the way it is planned. For a given illness, not all of the objectives mentioned can be achieved or are necessary. While many diseases are eminently curable, some can only be contained or their harmful effects mitigated. When there is potential for cure or complete resolution of the disease process, the plan is directed towards achieving it. Yet, others are inherently incurable or are too far advanced. However, when there is no possibility for cure, the plan offers other beneficial therapeutic options aimed at restoring functions, symptom relief and providing comfort. These three goals can be achieved using the strategies that may contain all or some of the following types of therapeutic (treatment) approaches or modalities i.e.:

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

Depending on the potential for altering the progress of the disease, the main treatment strategies or actions to be taken will include:

  1. Remove or lessen effects of illness (relief symptoms, provide comfort)
  2. Maintain, restore, or improve health status and physiological function (provide support)
  3. Avoid or minimize complications of treatment
  4. Induce remission
  5. Cure the disease (if possible)
  6. Prevent deterioration or recurrence

Each mode of therapy needs to be planned so that the optimal 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, in the SOP/Care Plan, 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:

  1. the conditions required to ensure its success
  2. the prevention of adverse effects
  3. the steps to be taken when complications occur

DESIGN BASED ON CLINICAL WORK PROCESSES

The greater part of the SOP/Care Plan addresses policies and procedures. Hence, the development of effective SOP/Care Plans requires a thorough understanding of the clinical work processes and the design is fashioned according to the sequence and conduct of it.

Care Plan 9

Procedure and Processes

All clinical care providers, including doctors, nurses, allied health personnel and others, follow a common generic set of processes, their layout and direction. 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

Sequence of Processes (Workflow)

The priority and flow of the processes does not necessarily follow strictly the sequence shown above. The workflow will depend very much on the type, severity, urgency, progress and effects of the illness. In an urgent case, emergency treatment is given first before a full interview, examination and tests are done. Some cases may have obvious diagnosis based on routine tests or chance findings from investigations already done during other instances of care. As such, it would not be necessary to repeat the diagnostic investigation. For some types of cases, it may be more practical to perform certain processes first as a routine for example performing urine tests at a antenatal visit or visual acuity measurements for every case with a problem of vision.

Concept of Triage

Triage (determining priority of care and dispersion of cases) as a concept as used in managing mass casualties and emergency situations can be applied at the beginning of care for all situations, even for elective cases.

Triage is done just after the patient has been registered. It should preferably be performed by a care provider with clinical experience. A SOP/Care Plan should be available even at this stage. The outcome will be the identification of a diagnosis in the form of a symptom complex or a syndrome unless the patient is a referred case from some other care facility where the diagnosis has already been worked out. The triage procedure will help in:

  1. directing patients to appropriate care
  2. speeding up the flow of the care process

Iterative Nature of Clinical Workflow

Clinical processes are iterative (cyclical, repetitive) in nature. Certain processes need to be repeated if:

  1. the process is effective only if it is repeated intentionally for a certain number of times
  2. the objectives are not met or desired results are not obtained by a single instance
  3. the results of processes (such as monitoring, review and measurement of outcome) are expected to vary (improve) as the care progresses

If processes are repeated as the care proceeds, without any change in plan, then it is sufficient to document the decision as “repeat as planned” or “continue monitoring” or “continue medication as prescribed”. Since processes are done based on orders, new orders have to be made if the duration of the initial order has ended.

CHANGE IN PLAN WITH THE PHASE OF CARE

A SOP/Care Plans is written as a narrative made up of segments or sections consisting of the clinical care processes required to be performed at various phases of the episode of care, as elaborated below.

When the diagnosis is uncertain the plan for the whole care episode cannot be very definite.  The care provider can put up an Actual plan only for the initial stage. When the diagnosis is clearer, the broad overall plan of care can be determined. Even then, because the workflow may take variable paths, only an outline of the latter stages can be stated. Once a definitive diagnosis is made and the appropriate treatment regimen is known, then the care for the rest of episode may be planned, initiated, optimized and maintained.

When the diagnosis is certain, definitive treatment is initiated. Even so, this cannot be accomplished in one sitting. Unless it is the treatment of an emergency case, the effects of treatment will take time to manifest. So, treatment is followed by monitoring of the patient which includes checking on the progress of the illness as well as monitoring of side effects. Rehabilitation would be added to the plan, in earnest. Progress review is done regularly to determine the effectiveness of the therapy. failure due to non-compliance to the plan by care providers and patients need to be excluded. Once an optimal regime is established, it should be continued until desired objectives are achieved.
If the plan itself comes into question, the reliability of the diagnosis and the appropriateness in the choice of the plan or the way it is customized need to be reviewed.

The Care Episode

The period within which the entire care of a patient with a particular disease or health problem (a case) takes place is considered as a care episode. It begins at the time of first contact with a health care practitioner and ends with the resolution of the illness/problem or death of the patient. In that episode, the patient may make several visits and during each visit, he/she may have encounters with many health care providers. He/she may be subjected to processes/interventions or experience incidents, all which are considered as events. Encounters and events usually occur in sequence. However, there are instances e.g. in emergency situations and in complex procedures (e.g. surgical operations) when more than one care provider may be attending to the patient at the same time.

Division of Care into Episodes, Encounters and Events

Dividing the Care Episode into Phases

Although the process of care is continuous, it is convenient in practice to divide the care into sequential periods or phases. Each of the phases is distinguished by the objectives that can be achieved during the period. For simplicity, the division can be into early, middle and later segments. Indeed, phases can be divided in different ways and be given different names (see below).
Actions taken at the earliest phase is often concerned with establishing the diagnosis, stabilization of physiological functions and immediate care. In the next phase, attention is given to starting the definitive care and optimizing it. This is followed by continuation/maintenance of care (treatment, monitoring and reassessment). Subsequent actions depend on whether the illness resolves such that care can be terminated or remain unresolved hence requiring long term care.

Variation of the Plan Based on Changes in the Characteristics and Behaviour of the Illness

The characteristics and behaviour of a disease varies with each occurrence. Its progress may be typical or atypical and may become better or worse. Complications of treatment may occur. The care provider modifies the existing Actual plan or if necessary selects a different Reference plan in response to these variations. Usually, the work flow advances as and when all tasks planned for the phase are completed and the objectives met. The phases of care of both acute and also chronic diseases are categorized into:

  1. Phase for establishing diagnosis, stabilization and immediate care
  2. Phase for initiation and optimization of care
  3. Phase for maintenance of care, re-evaluation and modification
  4. Phase for discontinuation of care in the event of resolution of illness

Designing SOP/Care Plans with Consideration to Phases of Care

In manufacturing, the processes in an assembly line occurs continuously without stopping. However, if we look at the entire manufacturing activity, there are separate lines for fabricating of parts, assembly and testing. Similarly, while the SOP/Care Plan describes the processes from the beginning to the end, it does not mean that it is performed continuously. The processes cannot be listed then as a long lists of process but have to be segmented into blocks. These blocks can correspond with phases and coincide with visits. The phases and the processes that make up the content of each phase is as shown below:

Content of Various Phases of Care

Hence the SOP/Care Plans is designed as segments with phases of care in mind.

Different Types of Plans

The Flow of the Clinical Process

Clinical pathway is another term for work flow and algorithms when it is used in patient-care activities. These terms can be used interchangeably. They are the predicted or planned series of sequential work processes guided by policies in managing a clinical problem. They provide 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 workflow as used in SOPs. The workflow/care pathway is an essential component of a documented SOP/Ca re Plan.

After selecting a plan based on the initial diagnosis, the care provider may alter or revise the plan based on:

  1. Changes in the understanding of the illness affecting the patient (the certainty and comprehensiveness of the diagnosis )
  2. Evolution of the disease along its natural history
  3. Advancement of the clinical process workflow
  4. Other emerging issues

There are instances when the workflow cannot progress according to the initial plan due to various impediments or circumstances. At times the process e.g. information gathering, investigations or procedures have to be repeated or abandoned. In those cases or if the prescribed treatment plan is ineffective, unacceptable or unsafe for the patient, an alternative approach or modality is used. Non-compliance by care providers or patients is also a factor that affects the progress of the workflow as well as the success in achieving the desired outcome.

The decision-making process that guides the necessity to change the Care Plan is depicted below:

Changing to Alternative Reference Care Plan in Response to Variations, Options and Contingencies

At the start of care (usually at the first visit) the primary provider chooses a care plan that matches the diagnosis. At subsequent visits the same the same plan may be used if appropriate. There may be a need to follow a sub-set of the plan depending on variations in the pathological grade of the disease, the stage of the disease, the level of severity or the emergence of complications.
Indeed a Reference Care Plan for a different disease must be chosen in response to a marked change in the diagnosis.

Plans are also modified or revised if various other emerging needs appear. If previously designed plans are not available then the care provider needs to devise the required plans him/herself. Hence, it is necessary to design and put together a comprehensive library of Care Plans to cater for certain periods/phases or scenarios in the care of a patient for each illness or health problem. The primary provider selects the appropriate plan from a library of SOP/Care Plans made available to him/her. practice, the health care provider delivers care at encounters / consultations with the patient, usually during a visit i.e. when the patient comes to the health care facility or are visited by health care provider or via Teleconsultation. Moving on from one phase to the next depends on whether the objectives of the former have been met. This depends very much on whether results of actions (assessment, tests and treatment) are immediately available or takes some time to be available. Many results would only be available after a time interval, it is necessary to have a break between the encounters or visits. Hence, only some part of the work process can be done at one encounter or visit. Therefor, for practical purposes the entire list of processes need to be broken up into segments or blocks.

Initiation and Continuation of Phases of Care to Coincide with Visits and Encounters

The division of care into phases is conceptual rather than practical. Dividing care into sequential phases is still insufficient.
In an inpatient setting, processes are performed during encounters with intervals in between. The exception is for the processes of continuous monitoring or observation (manually or by machine).
In an outpatient setting, more often than not, processes are performed in blocks at visits. There are of course instances when a care provider would attend to a case more that once (e.g. at the ordering of a test and after the results are available).
The the service setting (i.e. where the visit take place) deemed suitable for the process depends on the part of the workflow to be accomplished.

Segments of the Plan for Different Phases of Care

MATCHING PLANS WITH VISITS AND SERVICE DELIVERY SETTINGS

Service delivery may be provided in various settings including:

  1. Outpatient visit
  2. Emergency visit
  3. Inpatient visit
  4. Day Care visit
  5. Home Care visit
  6. Teleconsultation visit
  7. Self-care

Matching Care with the Appropriate Service Delivery Setting

Different types of disease and different phases of care has to be matched with the appropriate health care service delivery setting. Diseases that are sudden in onset with severe symptoms and physiological derangement need to be cared for in the Emergency Unit or an Inpatient facility. The of care of a patient with certain chronic illness at the initial phase involves intense care and therefore better carried out in an outpatient setting. Otherwise the care of patients with most diseases can be cared for on an outpatient or daycare basis. Telehealth as a service delivery system augments inpatient and outpatient services. It is better to start the first encounter with direct interaction where the care provider can use all his senses and instruments to examine the patient. Later when the care regimen is firmly established, interaction via remote audio-visual mechanisms and telemetry is more convenient for patients in lieu of visits to clinics.

Scheduling Care Activities

For practical reasons and convenience, service managers schedule visits to coincide with the anticipated change-over of the clinical care process from one phase to the next. If the workflow for the care of the case type or sub-type is studied the number of visits or encounters to complete a phase can be anticipated and scheduled as a feature of the SOP/Care Plan. For example, a patient who is on an outpatient follow-up may have to be admitted for in-patient care if certain complications occur. Inpatients should be discharged as early as possible so that nosocomial side effects can be minimized.
At the visit or encounter, tasks to be performed and other events that the patient will experience or incidents that is likely to happen to them can be anticipated by the care providers. Similarly, the patient should be aware of what to expect. What is planned for the visit may be continuation of the current SOP/Care Plan or a change in plan. However, the decision to execute the plan is made only if the patient’s status when reviewed allows for or warrants the change-over. This is especially true, for example, in ante-natal care where plans are made for phases coinciding with trimesters of pregnancy. While pregnancy inevitably progresses, certain processes or interventions that have not been successfully completed need to be repeated or continued.

In actual practice, the opportunity to decide on advancing to the next phase occurs during the visit and encounter itself rather than before it. Usually, it is then that the care provider reviews the patient’s condition and the accumulated data.

The most appropriate service delivery setting for a particular visit can can also be decided in advance. The difference in settings do not significantly change the clinical content of the SOP/Care Plans but affects mainly the administrative processes, workflow and use of resources.

Differences in Arrangement of Processes According to the Care Setting

When the patient is managed in an in-patient setting for either acute illness or the initial care of chronic illness, the care provider may review the plan for the case as often as daily or more frequently and decide on advancing through the phases.
For cases managed in the outpatient or daycare setting, the patient is reviewed at a follow up visit such that the decision to move on to the next phase is usually made then.

Planning at Every Visit

Differences in the Care of Acute vs Chronic Illness

In acute illness the disease progresses at a rapid pace. Hence, processes are also performed rapidly through encounters at short intervals or continuously. This means that the appropriate service delivery setting is ether the Emergency Unit or the Inpatient facility. at the immediate phase, Efforts are directed towards symptomatic relief, resuscitation, stabilization and support (physiological, psychological, social and spiritual).

The care of a patient with chronic illness can be carried out a slower phase. Except at the very beginning of care for some diseases, chronic diseases are suitably managed as outpatients. Care occurs at visits spaced by intervals. The appropriate interval between visits is determined by the expectation on the speed of progress of the illness, the readiness of results of tests, and the effect of treatment on the disease will become apparent. and the This gives time for the care provider to obtain a diagnosis with a high degree of certainty and the choice of the most appropriate definitive care plan. Except at the very beginning of care for some diseases, chronic diseases are suitably managed as outpatients. Phases of care move along visits rather then encounters. Involvement of the patient in care of his/her own at home is essential. For incapacitated patients, their wards will take that role. The same is true for parents in the care of their children.

Dividing Processes into Blocks to Coincide with Visits and Encounters

It is obvious that in the SOP/Care Plan processes must be grouped together, taking into consideration when and where they are supposed to take place. However, it must be emphasized that phases do not coincide necessarily with visits or encounters.

The processes planned for the First visit is quite different from that for the Follow-up visit because at the very first visit the diagnosis is usually uncertain, while at subsequent visits, the diagnosis is more definite. So, processes for the initial phase of care is assigned to the first visit. The later phase of care is initiated at the next visit depending on whether all objectives of the first phase has been met. Otherwise, the processes of the initial phase has to be repeated over more than one visit or encounter. If, at later visits some part of the care process has been completed they can be adopted and continued. Then, plans need to be made only for the remainder. At each visit or encounter the care provider has to make decisions on whether to:

  1. proceed to the next phase on the current plan
  2. change the current plan altogether or in part to another plan

The phase of clarifying the diagnosis, ends when a definite diagnosis is identified with some certainty. If, for example, the result of a test is pending it has to be waited for. If findings are equivocal, more tests may have to be done. In that situation, the phase is delayed. Moving from initiation and stabilization of definitive care to the maintenance phase depends very much on the effectiveness of the care given or improvement in the disease condition. Otherwise, the care persists in that phase. At some point, the care provider has to decide whether the patient requires further care (follow up visits) based on the resolution of the illness or the achievement of the optimal outcome. There is no advantage in putting the patient on regular follow up when it is unnecessary. However, access to the service can still be offered on a needs (prn) basis. It must be noted that a phase may need more than one visit to complete.
The term ‘care’ is preferred because many other elements/aspects besides treatment or therapy contribute to improving the patient’s status. The grouping of processes into blocks corresponding to particular visits and phases of care is depicted below:

Phase for Determining the Diagnosis and Immediate Care / Early Treatment

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 its natural history, 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, clinical syndromes or as a disease belonging to a diagnostic related group. Care 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.

In acute illness at the immediate phase, efforts are directed towards symptomatic relief, resuscitation, stabilization and support (physiological, psychological, social and spiritual). At the outset, observation and monitoring are initiated. Investigations is aimed at determining the patients general physiological status and  functions of various systems. The priority for Diagnostic investigations is to determine the system or site involved or the like pathology. Therapy must not wait for want of an accurate diagnosis.

Yet every effort must be made to obtain a definitive diagnosis so that the plan for specific treatment can be started as early as possible. The diagnosis need to be further refined to clarify the variant of disease, severity grade, stage of illness, risk and expected or desired outcome.

The care of a patient with chronic illness begins with the 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.

t is essential that the care provider plans for the continuity of care well and ensure that it happens. He/she may delegate the responsibility to others for the convenience of the patient. The primary care doctor, family doctor or school/factory nurse are the most appropriate care providers to take on this responsibility. If it is a disability or handicap, depending on the type, then therapists, counselors, optometrists, audiologists or social workers may be more appropriate. Self-care, home care and care by voluntary bodies may be adequate or may supplement those given by health care professionals.
Periodic review by the provider who initiated the plan may  be necessary.

Processes in the Phase of Diagnosis and Immediate Care

Phase for Initiation of Definitive Care

Once the diagnosis is ascertained the care provider needs to clarify the objectives of care (expected outcome, therapeutic end points). A more definite Care Plan is then chosen and customized.

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. contain it or control it.

In this phase, the disease entity/entities and accompanying health problems affecting the patient are already established with some certainty. As such, treatment end points need to be defined and measurements made to determine whether these end-points have been achieved. Depending on the disease, the objective of treatment would be to be the combination of any of the following:

  1. cure the illness,
  2. contain it or control the progress
  3. mitigate the effects

An appropriate definitive management plan influenced by the care objectives is adopted and implemented.

The progress of the patient is reviewed regularly to detect deterioration or improvement, occurrence of complications of illness or treatment. The care provider reviews the diagnosis and the effectiveness of therapy. He/she then, may have to revise the Care plan and modify the treatment.
Depending on the illness, this phase may spread over a considerable period. The patient may be discharged from in-patient care and the care continues in the outpatient setting or at home.

As such, the care provider defines the treatment end points,  chooses the plan offering the most suitable treatment approaches or modalities. As such, treatment end points need to be defined and measurements made to determine whether these end-points have been achieved.

Phase of Initiation of Care

Phase of Optimization of Care

In this phase, the care provider need to be constantly aware of the desired treatment end points and evaluate them through feed back from patients, observations, monitoring and repeated investigations to determine whether these have been arrived at. Optimization is considered achieved when the care regimen produces the best possible level of benefit. To this end, the care provider need to make adjustments and modifications to the care plan.

Measurement of outcome and comparison with planned targets is an integral activity of care at this stage. Scoring systems and check lists can be used. . The plan is then continued with minimal change.

Phase of Optimization of Care

Phase of Maintenance of Care

The progress of the patient is reviewed regularly to detect deterioration or improvement, occurrence of complications of illness or treatment. The care provider reviews the diagnosis and the effectiveness of the care given. He/she then, may have to revise the SOP/Care Plan and modify the treatment.
Depending on the illness, this phase may spread over a considerable period. The patient may be discharged from in-patient care and the care continues in the outpatient setting or at home.

The main aim of this phase is to optimize the benefit of care given. The main tasks in this phase is monitoring, reassessment and progress review addressing both the disease and also the treatment. The results will reveal the behaviour of the illness and various developments. The progress of chronic diseases vary in many ways including:

  1. speed of deterioration
  2. active vs inactive periods
  3. emergence of complications

Another important aspect is the evaluation of response to and effects of therapy. These factors are assessed:

  1. conformance to the plan
  2. patient compliance
  3. detrimental effects of therapy

Measurement of outcome and comparison with planned targets is an integral activity of care at this stage. Scoring systems and check lists can be used. Optimization is considered achieved when the treatment regimen produces the best possible level of benefit. The plan is then continued with minimal change.

Once the patient has been stabilized, attention is paid to:

  1. relief of symptoms
  2. monitoring various parameters
  3. maintaining normal physiology,
  4. providing nutrition,
  5. giving psychological support
  6. taking preventive actions
  7. treatment of ongoing problem

Phase of Maintenance of Care

Phase of Continuation or Discontinuation of Care

Depending on the nature of the illness and the response to care, the service may reach a stage where it can be discontinued.

Chronic illnesses are usually characterized by continuous progression or persistence. The care is therefore long term and usually extend throughout the life of the individual. Some may resolve, go into remission and be dormant only to appear again later. Temporary cessation of therapy with planned follow up reviews may be necessary.
Rarely some diseases runs through its course and dissipates. The care can then be phased out.

If the illness appears to have resolved, discontinuation may be abrupt or phased out. The plan conveys the manner in which care is to be stopped including how medication or other treatment is to be tapered and what evaluation criteria need to be met to declare it safe for the care to be terminated.

On the other hand, the acute illness/health problem may be a manifestation of an underlying chronic disease justifying further observations, monitoring and investigations.  The acute illness may also give rise to permanent or semi-permanent disability, deficiency or handicap. In both instances, long term care will then be planned and provided.

Phase of Continuation and Discontinuation of care

Revision or Complete Change of the SOP/Care Plan

For every case, the actual SOP/Care Plans are revised frequently based on the ever-changing changing needs (brought about by changes in diagnosis or condition of the patient or occurrence of events). The revision is documented as part of the plan in Progress Notes.

Decisions to start, continue or abandon plans are dependent on the data available. In inpatient care, the data available are results of clinical reassessment, monitoring data and routine investigations. For outpatient care, these data can be made available by asking patients to come for a preliminary visit when investigations and other assessment are performed. As part of self-care, patients may also submit records of symptom characteristics and measurements they make themselves (Body weight, Blood pressure, Temperature, Blood sugar level, etc.).

PLANNING THE FREQUENCY, INTERVAL AND DURATION OF VISITS

The extent of each phase, is a variable period. It can span a duration of mere minutes or can stretch across many encounters and visits. Case managers or the primary provider set the frequency of encounters and visits based on the patient’s expected response. The number of visits per episode is by nature variable but may be intentionally fixed in a service delivered as a package.

However, there are situations where the transition in the plan is predictable such that a change-over of the plan can be initiated as and when the visit takes place. A good example is the care plan for the care of a patient with normal pregnancy or a patient undergoing Knee replacement surgery. The interval between one visit or encounter to the next is dependent on two factors:

  1. the expected behaviour of the disease according to its natural history
  2. the expected duration for the treatment or intervention to take effect

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 using the same or different resource. The duration of each encounter is defined as time slots. All these need to be planned. In a computerized HIS, this planning is done using the scheduling and resource allocation application.

COMPONENTS OF THE REFERENCE SOP/Care Plan

Standard Operating Procedures are descriptions of how work is to be carried out for a specific category of patients defined mainly by the diagnosis. Each comprises many specific components. Reference SOP/Care Plans should contain the following components:

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

Care Plan 4

Content of SOP

SECTION CONTENT
1 Title Name of the Service Product
for which the SOP/Care Plan is Applied
2 Service Product Description of the Service Product
i.e. the services to be given
A. The typical patient group
for whom the SOP/Care Plan is applicable
B. The Needs of the Patient to be served
a. Primary  Diagnosis
b. Disease Complexity (type, grade)
c. Severity Level
d. Stage of the Disease
e. Effects and complications of the disease
C. The location where and the care providers
who provides the service
3 Objectives The Desired Outcome
of the care given with regards to:
A. Productivity and Efficiency
B. Effectiveness
(Cure / Containment / Support / Relief / Comfort)
C Safety (Risk assessment, Prevention)
D. Quality
4 Policies and
Procedures
Description of Policies and Procedures
to be followed including:
A. Operational policies (rules and regulations)
B. Methods, modalities and Processes
C. Input required (expertise, material,
machines, equipment)
D. Workflow,
and links to related SOP/Care Plans
E. Phases of Care (Episode, Visits,
Encounters, Tasks and Events)
F. Work Schedule
(Orders, Tasks, Task , Time table)
G. Guide to decision making
I. Guide to documentation
F. Reference documents
i. Work instructions
ii. Specifications and Standards
iii. Forms and Charts
5 Quality Control Quality Control Methods
a. Methods to Ensure Conformance
b. Preventive measures
c. Quality Measurement
d. Comparison with Standards
(Detection of non-Conformance)
d. Rectification and Damage control
Structure and Content of an SOP/Care Plan

TITLE: THE SERVICE PRODUCT

To clinicians, the ‘care’ or ‘the management of a patient’ is the provision of the entire service or care for a certain patient according to his/her needs which are determined largely on the identified diagnosis or health problem. The title of the reference SOP/Care Plan should show that it is designed for the ‘care’ of this specific disease or health problem. As such, the Service product consists of a well-defined set of services to be provided for a typical patient (case) who has an episode of a specific illness. Yet it is, to a certain extent, still generic and would need customization, by additions or omissions, when it is used as the Actual SOP/Care Plan in the actual care of an individual patient.

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.

Description of the Service Product

Following the title, what the service is for and what is contains is described briefly.

The examples below, illustrates two main service products Care of a Patient with Bronchial Asthma and Care of a Patient with Intertrochanteric Fracture of the Femur. How the service is further refined is as shown below:

Types of Service Products

In the case of Bronchial Asthma, the service can be differentiated into more refined products based on acuity of onset/urgency and then further into types based on severity levels. The care for Acute vs Chronic Asthma follow quite different approaches. Some of drugs are used for all types but a few will be used only in certain types.
In the case of Intertrochanteric Fracture of the Femur, variations the service products being offered will have different characteristics to suit the different requirements necessitated by degree of fragmentation and displacement. While the main service will contain the service elements of managing a fracture the main difference for the various types will be in the surgical treatment.

OBJECTIVES OF CARE

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.

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

  1. expected outcome,
  2. treatment end points
  3. 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)
  4. 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.

Description of Policies and Processes

In an SOP, the policies and processes are presented in two forms i.e.

  1. A textual description (narrative)
  2. A work-flow chart

When designing the SOP/Care Plan, starting with the narrative description is the bet way to go. However, when presenting it as the final document it may be better to show the graphical workflow first.

Detailed Textual Description of the Policies and Processes

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 and the policies that guide it. 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 embedded in the description of the processes.

The sequence, direction and layout of processes or tasks that makes up a procedure must be described clearly and in detail. It is best written before or at the same time as the flow 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 SOP/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 the 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 performed, findings, and outcome
    • Review of (monitoring and test) results and interpretation
    • Quality Control Procedures (e.g. check lists)
    • Progress review, assessment of outcomes
    • Communications (Referral Notes, Replies), requests and orders
    • Summaries

OPERATIONAL POLICIES

At the operations level (i.e. when work is performed), 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

  1. Take history of frequency of exacerbation, limitation of activity & night-time symptoms
  2. Examine patient
  3. Perform PEFR
  4. Assess response according to these criteria:
    • frequency of exacerbation,
    • limitation of activity,
    • night-time symptoms and
    • PEFR
  5. 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.
  6. 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)
  7. Give explanation regarding the new added medication and further education on use of bronchodilator, use of PEFR meter and self-monitoring chart
  8. End the visit and give the patient an appointment date for a follow-up visit in one month.

WORK FLOW/CLINICAL CARE PATHWAY

Besides describing the path/flow of how the service is given as a narrative, it is also depicted graphically as a chart using the generic clinical work flow, described earlier, as the basis. It may be better to present the workflow before the text description but the idea is for the user to switch from one view to the other regularly. An example is shown below:

Clinical Care Pathway for Care of a Polytraumatized Patient

The work flow (care pathway)  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

It is good to draw an outline of the processes (the critical pathway) to show the entire scope of the service. It is not necessary to depict the entire pathway completely on one page as it maybe quite long. Instead, it can be truncated and shown as a continuation on another page, Deviations and variations can be written separately and links/references to them made to the main document.

THE WORK SCHEDULE

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

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

Care plans/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 schedule of the 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.

Task Lists

Care providers may then create their own task lists based on their role. In a computerized environment, these task lists are automatically generated but can still be amended to vary the urgency, frequency, duration, location and assignment.
Task lists are the means for executing the SOP/Care Plan. Care providers must be aware of the tasks that have been completed and those that are still pending. When a computerized system is used, the system is able to note the status of performance and provide reminders through prompts and alerts.

Multi Patient Task List View

The care set for a particular patient will consist of all or some of patient care processes. It may also include clinical administration tasks. 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.

ORDER SETS (CARE PACKAGE, CARE-SET, CARE-BUNDLE)

Quality Control Methods

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).

GUIDE ON DOCUMENTATION (USE OF FORMS OR CHARTS)

 Relationship between Plan, Performance and Documentation

Pertinent data that is generated as results of tasks or processes must be recorded in standardized forms. In the SOP, guides are given on the use of various data documentation forms or charts used by the organization. Documentation forms should anticipate the data generated by the tasks within the SOP/Care Plan. In addition, the forms/charts also provide prompts/reminders for the care provider to perform certain tasks to obtain the data. Thus, the form itself acts as a decision support instrument

PROVISION OF CLINICAL DECISION SUPPORT

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 SOP/Care 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 that must 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-conformance and abnormalities
    • indications and contraindications in use of a modality

SUPPORTIVE REFERENCE DOCUMENTS

Reference Documents

The SOP should contain reference documents that care providers can refer to when performing their tasks. The information provided should be endorsed officially by the organization . Examples of these include

  1. work instructions or protocols
  2. table of normal values,
  3. percentile charts,
  4. dosage regimens, food menu,
  5. expected / control limits, standards, specifications,
  6. regimens, recommended drug dosages and charges.
  7. lists of drugs (official drug formulary)
  8. glossary of terms ,
  9. diagnoses terminology,
  10. charge codes.

Care Plan 7

Care Process with Decision Support through Reference Documents

Work Instructions or Protocols

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

Reference tables or lists may become part of this work instruction.
Since processes depicted by a work instruction would be performed in a similar manner at any time, location or for any indication, they may be compiled separately as an addendum to the SOP or kept in separate manuals/folders and only referred to if required. In a computerized system they can be reached through hyperlinks.

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

DIAGNOSTIC CRITERIA

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 (as decision support) 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.

Categorization, Risk Stratification / Severity Grading/ Staging

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

As such, grading and scoring systems for various diseases should be adopted for each disease and the care plan should have variations for different severity levels, stages and grades.

INDICATIONS AND CONTRAINDICATIONS FOR USE OF A MODALITY

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.

ALTERNATIVES, VARIATIONS, OPTIONS AND CONTINGENCIES

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

The Objectives and Expected Outcome

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.

Lists of Tasks

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

SOPtoPlan

From SOP to Care Plan

Relationship Between SOP, Reference Care Plan and Actual Care Plan

Specific disease entity which give rise to further stages or phases

PlanPhaseDiagnosis

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:

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

Phase of Care

Phase of Care

Outline of the Care Episode

Care plans also need to vary with other changes including:

The Reference Care Plan is in three parts:

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

Care Plan Table

Reference Care Plan Table

Customization of Case Management Plan for an Individual Patient with Multiple Needs

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.

Executing Plans via Orders

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.

Plans are realized by executing orders (planned tasks). While in the Reference plan, tasks are grouped according to purpose or function, for purposes of execution they are assigned to identified members of the care team. For example rehabilitation tasks are allocated to the Physiotherapist or Occupational therapist. The dietitian takes on the provision of appropriate diet. The social worker will address the social support issues. These care providers will have to be alerted regarding their involvement in the care of the patient through e-mail (in-box), by phone or other methods of referral.

Actual Care Plan for Acute Coronary Syndrome

Order Set 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.

ORDER SETS (Care Package, Care-Set, Care-Bundle)

The tasks that addresses all aspects of the patient’s health problems for the short term, make up the content of the Actual Plan. It is often called the Care Set, Order Set or Care Bundle.

Each Care Plan is executed using pre-constituted but modifiable order sets. In a system based on paper the orders are transcribed (copied) manually from a printed copy of the Reference Plan or from a stand-alone computer. In a computerized Clinical Information System, the care provider may use the order set suggested by the system or choose one from a given list. Depending on the context or scenario, order sets can be didactic or flexible in content. In any case, the set can then be modified by exclusion or inclusion of orders.  The tasks are then assigned to the relevant provider group as a task list. Tasks are performed according to the orders.

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 are put in place.

TASKS: THE MAIN CONTENT OF CARE PLAN

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.

PROCESSES AND TASKS 

Traditionally, the plan for the overall care of a patient is done by the doctor in charge (or any primary care provider). By choosing a Care Plan he/she communicates the to members of the care team on what needs to be done for the patient.

  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.
  3. Analysis and interpretation of data to determine the diagnosis and needs of patients
  4. Investigation tasks, Diagnostic tests
  5. Planning the case management
  6. Treatment using various modalities including therapeutic procedures, medication to be supplied or administered, blood product supply and transfusion
  7. Review of progress of disease (including assessment of outcome)
  8. Monitoring of the progress of the illness, status of the patient’s health, effects of treatment
  9. Review of diagnosis and management
  10. Rehabilitation
  11. Patient education
  12. Nutrition provision
  13. Any other therapeutic tasks
  14. Continuation of care or Final disposal of the case

Multi Patient Task List View

In a computerized Clinical Information System, planned tasks take the form sets of orders. The computerized provider Order Entry application (CPOE) is used to create task lists for various functions. The type of tasks within a care-set would include any or all that is necessary to carry out the patient care processes i.e.:

DECOMPOSITION OF ORDER SETS INTO TASK LISTS

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

Care Schedule 3

Care Schedule

PRACTICAL CONSIDERATIONS IN EXECUTING PLANS

For a chosen plan, the transition from one phase of care to the next depends on:

  1. completion of planned tasks
  2. achievement of objectives for the phase

Failure to complete tasks can be due to non-conformance by care providers or non-compliance by patients. Failure to achieve objectives may be due to the two aforementioned issues or due to an inappropriate hence ineffective plan. The latter is likely to be due to inaccurate or wrong diagnosis, in which case further efforts need to be made to clarify the diagnosis. A change in plan may then become necessary.

Phases of Care

Framework for Patient Care Plan

Phases of Care in a Patient with Blunt Chest Trauma

 

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CARE PLAN FOR ACUTE ILLNESS

  1. quick action by defining the process sequence
  2. readiness of equipment,
  3. defining care-provider roles
  4. preparedness for any eventuality

 

Example of Care Plan for Patient With Multiple Needs

  1.  

PRACTICAL CONSIDERATIONS IN EXECUTING PLANS

Care of a patient with an acute illness is characterized by  varying levels of urgency and uncertainty. Setting priorities is of overriding importance. Most tasks need to be performed simultaneously. The Care plan is an indispensable aid in ensuring:

Customization of Case Management Plan for an Individual Patient with Multiple Needs

CARE PLAN FOR CHRONIC ILLNES

preventive, education An example of the model care plan for this phase is shown below. (yet to be written)

In this phase because of the above factors, modification and revision of the plan is often necessary.

VARIATION BASED ON EMERGENCE OF SPECIAL NEEDS

In managing a patient, an integrated plan that will cater for all of his/her needs is necessary. For a particular disease, there are individual variations in how the disease or health problem affects a patient. How the patient responds to them also varies. The continuation of a care regimen to the next phase is contingent on the completion or success of the previous phase.

To some extent the difference in response is contributed by the patient’s pre-morbid health status (pre-existing problems including chronic illness), physiological condition and psychological make up.

After making a diagnosis, 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 initiate 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.

Cessation and Introduction of New Plans

Plans need to change with variations in progress of the disease, severity, complications, different phases of care and outcomes. Changes can be made manually or be suggested based on a trigger. Planned tasks may end or continue as the phases evolved.

Tasks can continue or retained in new plan. Tasks no longer necessary are not included in next plan any task can be cancelled from the task list at any time

Whether the changes are slight or major, in a computerized system, it is best that the old plan is terminated and replaced by a new plan. Previous orders that are to retained are cancelled and the orders  are remade. The new order set will then contain previous and new orders. Hence, the task list is also renewed. This will prevent confusion as to which order is to be retained and which to be continued.

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

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