Standard Operating Procedures and Clinical Care Plans

Date First Published: January 9, 2015
Date Last Revised: October 20, 2021

“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 also taken years to prepare. I have also tried to apply the concepts through various projects with some success. There were many false starts and yet 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. Readers, trying to get through this article may find it quite daunting. There are repetitions, and for some content, details are spread over a few sections. I have tried to present it as simply as is possible. I have gone to great lengths to explain the work of a clinician because readers are likely to include non-clinicians ranging from managers, administrative staff and people involved in information management. All need to understand each other’s work. However, SOPs are designed to improve consistency such that details are necessary. I hope you will bear with me and persevere in trying to go through reading it.

A. THEORETICAL CONSIDERATIONS

INTRODUCTION

When used in manufacturing industries, the Standard Operating Procedure (SOP) describes the plan for the work of producing a product. The entire method used to produce the product is termed as ‘operations’ which consists of a set of units of work called ‘procedures’. The term ‘standard’ refers to the uniform way that workers are expected to carry out the procedures. The product of manufacturing nearly always has specific characteristics (specifications) and rather rigid methods of production. Therefore, a SOP is applicable for the production of a particular object or item.
The product of services can also have fairly uniform characteristics and be called service products. The operations of producing a service is termed as service delivery.
The delivery of services aimed at keeping persons healthy and to respond to diseases / illnesses / health problems affecting them uses the alternative word ‘care’ and the industry is called ‘healthcare’. Hence workers in the industry are known as ‘care providers’. Since there are many types of diseases, there are correspondingly wide varieties of service products.

TermMeaning
workthe expenditure of energy to realize a useful outcome
processesthe most elementary unit of work
proceduretasks, a series of processes
productthe useful outcome (object or benefit) achieved through work
servicean instance of providing a benefit to a customer
healthcarethe service of promoting, preventing, maintaining and restoring health
operationsthe entire effort of producing a product
standardthe common way to conduct an operation
SOPdescription of the proposed/prescribe way of the work of producing a product
Glossary of Terms re: SOP

Currently, there is an increasing awareness worldwide of the need to regulate healthcare services, streamline health care funding and ensure uniform quality of care. 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). Accreditation bodies also expect healthcare facilities to have documented policies and procedures.

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 experiences and 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 this can be made to be equivalent to the ‘Standard Operating Procedure (SOP)’ and there is no reason not to call it such.

Applicability of SOP in Healthcare Setting

Since there are many types of diseases, developing SOPs for the correspondingly wide varieties of service products would be a challenge.

Aspects of Healthcare Amenable to Use of SOPs

Some aspects of healthcare services are not very different from other services in as much as they have fairly uniform output characteristics. Also, the policies and procedures can be followed fairly rigidly. Such areas include:

  1. Administrative services (registration, scheduling appointments, resource allocation)
  2. Non-clinical support services (e.g. laboratory, imaging, sterilization),
  3. Ordering, supply, and assignment.

Applying SOPs in those types of services is not difficult. It has been tried for some time with success. However, problems arise when attempting to apply them for clinical services. This is because clinical patient care has characteristics that pose difficulties to the adoption of the use of SOPs.

Challenges in Using SOPs for Clinical Patient Care

Clinical patient care services are planned according to the needs of patients. For a start, 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 contention of this article is that 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. 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

Traditionally, planning is part of the series of processes in the delivery of patient care (described in another article).

Planning as Part of Patient Care

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

The plan is then executed and the results are evaluated. It is redrawn if necessary. The challenge is to standardize and formalize the method.

Planning in Industrial Setting

The way planning is done in patient care as described above, differs significantly from the approach in in industrial setting. In the latter, the scope of planning encompasses all activities from the very beginning of production. Industries use the SOP as a plan that describes the entire method (operations) of producing a product or delivering a service. Hence, instructions are provided for actions to be taken from the very beginning. This is unlike the traditional thinking in clinical medicine (mentioned above) where planning is thought to happen after the diagnosis has been made.

Difference in Approach: Industrial vs Patient Care

Just as the aim of manufacturing industries is to produce useful products, both the effort and the outcome of delivering services can be can be taken as products as well.

If an SOP/Care Plan is to be developed for patient care the same approach as other industries must be taken. Every action taken to deliver the service must be included in the plan. This way of thinking is better understood if the care of different types of patients are considered as service products.
Thus the initial step of information gathering and obtaining a diagnosis must be included in the SOP/Care Plan. Indeed, as will be shown later, planning clinical patient care will have to be integrated with the planning of the management of patient care as a whole including the administrative, communicational and other related aspects.

PATIENT CARE AS A SERVICE PRODUCT

To apply the concept used in industry to patient care, it has to be assumed that the service to be offered to the patient can be identified as soon as the person seeking care arrives at the facility. If possible, the service to be given is determined at the moment of registration or immediately after it. Care providers build the service product around the diagnosis. Patients seek care services for a reason. For follow up cases, this is not a problem as a diagnosis has been made at the previous visit. For new cases knowing what service to provide is a challenge. Yet even at the start, the diagnosis can be determined by fashioning it around the reason for visit even if it takes the form of symptoms or complaints. The set of symptoms (symptom complex) supplemented by the discovery of certain signs that are obvious on observation or through simple assessment (at triage) can be taken as a preliminary diagnosis used to infer the needs of the patient and the service that they should be provided. If the preliminary diagnosis is expressed in a standardized way as the reason for visit, symptom complexes and clinical syndromes, then the SOP, even for patient care, can describe the service to be given from the very beginning. The difference (as will be discussed later) is that the service product changes as the diagnosis becomes clearer.

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 product. Services in healthcare are numerous and diverse. The challenge here is to define the service products and then design the SOP/Care Plan for each of them.

SOP/CARE PLAN AS A SERVICE DELIVERY PLAN for a DISEASE

The care of a patient (usually referred to as a case) is based primarily on the identified diagnosis (disease, illness, or health problem). Therefore, the logical approach would be to design the SOP/Care Plans for the provision of services for patient groups (case types) affected by the same disease, illness, or health problem. That service and its outcome can be called a service product.
Even though diseases are diverse, the medical profession, in general, follows a uniform way of managing them as described in:
https://drdollah.com/clinical-care-processes/

Illness, Disease and Health Problem

From the perspective of developing SOPs/Care Plans for service products, the terms illness, disease and health problem need to be defined objectively.

TERMMEANING
IllnessThe feeling of something not normal about a person’s health. It may accompany a disease, which may still be undetected,
DiseaseA specific condition of ill health distinguishable by a known set of criteria that can be a mix of:
clinical manifestations,
underlying pathological process detected through tests or
observed behavior.
Disease usually causes illness, but can also exist without any obvious manifestation (latent, dormant, asymptomatic).
Health problemA state of deviation from normal function or morphology that can be:
part of an illness,
a separate infirmity, disability. deformity or malfunction.
Meaning of Terms re: Ill Health

It is often thought that SOP/Care Plans can only be designed for a diagnosis in the form of a specific disease. The unique problem in patient care is that, almost always, the service product is based on the diagnosis but the diagnosis is not known with certainty at the start, Yet, patients expect that the care provider provides care as and when they request for it. The solution is to widen the use of the term ‘diagnosis’ to include illnesses and health problems rather than just specific diseases. The clinician should be able to provide a diagnosis even before the information making up the diagnostic criteria for a specific disease is obtained, Therefore, there is a need to address the presenting health problem from the general to the specific, from one less accurate to one that is more certain.

Ill health can be expressed as a hierarchy of entities based on increasing certainty. The illness as expressed by the patient can be identified as a group of symptoms termed as a symptom complex. The pattern of symptoms provides a pointer as to the scope and direction of of further information gathering. At this point, the main concern of the service is relief of symptoms. Subsequently, when signs are elicited and results of simple tests are obtained, the patient can be placed into a distinct entity termed as a clinical syndrome, or a diagnostic related group, Clinical syndromes are characteristic of certain groups of diseases. From the the mix of information, the care provider can infer the possible underlying disease (the differential diagnosis). At this point, care addresses various problems common to the group and care is given corresponding to it. Hence, SOP/Care Plans must be created for the care of patients diagnosed at these levels of certainty.:

  • reason for visit,
  • symptom complex,
  • clinical syndrome,
  • a Diagnostic related group (DRG),
  • a specific disease (identified by named diseases and their sub-types).

The service product can be named after these wider range of diagnosis and named using accepted terminology e.g. derived from ICD-10 Classification of diseases and SNOMED.

Further Refinement of Care for Variations of a Disease

After designing SOP/Care Plans for a specific disease. variations must be developed for sub-types of it 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.

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 knowledge and methods from many areas. Their content and structure should have the following characteristics:

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

With training, the terms and conventions used in operations management in other industries can be understood and adopted for use by healthcare providers, 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

The use of a 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.

Benefits to the Healthcare Profession

SOP/Care Plans that are developed based on sound theory and experience (research, consensus and best practices) will benefit the healthcare profession as a whole by promoting:

  1. evidence-based practice
  2. uniformity and standardization

Benefits For The Care Provider

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

  1. Facilitate care that follows 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 implementing a SOP/Care Plan, it is assumed that the care provider is conversant with its purpose, content and structure. The theoretical rationale, objectives and methods need not be presented in detail but referred to (through links or appendices) or summarized. In addition when performing specific tasks, instructions 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
  6. Provide predictability in resource planning (staffing, facilities, equipment, technology and information)
  7. Form the basis for the development of information systems

Benefits For The Unit Or Department Manager

From a service or department manager’s 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. Act as a basis for quality measurement and control
  4. Encourage equitable care and remove bias
  5. Improve staff knowledge, skills, attitude and behavior

Benefits From the Business Perspective

From a business perspective, the SOP/Care Plan defines the the package or bundle of tasks and input that make up a service product. Charges or the funds required can be calculated by costing the type and number of tasks to be done, the degree of difficulty, the time taken and the resources (workers, facilities, equipment and raw material) required to deliver the service. Indeed, currently many funders such as insurance companies and government agencies rely on care plans to justify claims or to provide funds to facilities. Reduction in costs by the use of care plans has been shown in one study.

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.

Standardization of procedures allow the accumulation of more reliable data that can be used to determine use of resources and outcome (success and failures). The information can be used to predict trends and enable planning.

OVERCOMING DOUBTS ABOUT USE OF SOP/CARE PLANS

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

  1. people following them blindly (“cook-book” medicine)
  2. loss of clinical freedom
  3. may be misused in medical negligence litigation.

The first concern is valid and should be addressed by building in variations, exceptions, alternatives and contingency plans into their design.
For the second concern, 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.

Medical negligence is defined as “an act or omission (failure to act) by a medical professional that deviates from the accepted medical standard of care”. The worry here is that the SOP/Care Plan can become the de facto medical standard. The argument usually made is that documented the SOP/Care Plans make the standard too certain whereas without it the criteria negligence lack certainty and provide leeway for defense. Clarity should be welcomed. At the moment the term evidence-based medicine is the by-word for the accepted way. Yet, the term ‘evidence’ itself need to be clearly defined. It should not be construed as only what transpires from research or what is printed in journals. SOP/Care Plans may be a better basis for defining the acceptable standard because it takes into account the practical aspects of practice in a specific work environment taking into consideration the limitations that exist. Indeed, information derived from actual practice (best practices) have value that research do not provide.
Most medical practitioners (with the exception of those in lone practice) work in a facility where they are dependent on other care providers. In fact, the facility is as liable to claims of negligence as the practitioner. There is a need for the facility to advocate common policies and procedures and provide it as SOP/Care Plans. Making them available is part of good governance. If they are designed based on scientific knowledge, research findings, best practices, consensus and experience, they act as a shield for practitioners from unacceptable practice. However, not following the SOP/Care Plan to the letter should not be construed as deviating from the norm. The care provider is allowed to modify elements of the SOP/Care Plan based on his/her own judgment when faced with certain situations. It is advisable to record and explain the reason for the variance from prescribed policies and procedures.

DESIGN OF THE SOP/CARE PLAN FOR HEALTHCARE

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, events and sessions 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
    • Strategy Based On “Quality By Design” Concepts
    • Use of the “PDCA CYCLE”
  2. Ensuring that the plan is feasible (usable within the facility) 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 by design concept, 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 practiced in modern quality management (as advocated by Juran and others). The delivery of a healthcare is a service product described in the form of a Standard Operating Procedure (SOP) / Care Plan. As a product, the delivery should be guided by the quality management strategy of:

  • Quality by deign
  • Quality control
  • Quality improvement

The SOP/Care Plan must describe the characteristics of the product and the processes involved in achieving characteristics. The service delivery must be strictly controlled and whenever possible improved.

The design of the SOP/Care Plan consists 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 characteristics specific to the client
  3. Setting the expected or desired outcome
  4. Clarifying the components of the service delivery system (input and process)
  5. Delineating the sequence and layout of work flow (the Care Pathway)
  6. Clarifying and detailing the processes involved as instructions (the Work Procedure)
  7. Stating the rules that regulate the service (policies)
  8. Choosing the most appropriate technology or modalities to be used
  9. Assignment of responsibilities to various service providers
  10. Identifying the monitoring and control measures (Monitoring, Review and Evaluation, Quality Control)
  11. Providing the means for data documentation (Clinical documentation, Forms, Charts, Information systems)
  12. Catering for variations, exceptions and contingencies by providing alternatives
  13. Anticipating possible errors of omission or commission, their prevention and damage control

Modern clinical care practice has within it means of adherence to a prescribed method. These should be taken advantage of and further enhance. In terms of improvement, because the plan of the delivery of care is dynamic (subject to reviews and repetitions) there is constant efforts at quality improvement for each particular patient (a case). Subsequently, through the application of Medical Audit improvements can be made for the type of service product. The quality management aspects of clinical care as applied to a service product will be discussed in relevant sections below.

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

USE OF THE “PDCA CYCLE” DURING DEVELOPMENT

To develop a plan that is effective and implementable requires a proper development approach. The Shewhart-Deming-Imai PDCA Cycle is the most dependable method. 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. Innovations should be introduced through proper research, not through deliberate changes to the existing SOP./Care Plan
Once adopted and put into practice there is a need for audits to be performed to monitor conformance to it and to determine its effectiveness. Development of plans is a never ending continuous learning process.

Basis for SOP/Care Plan

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 clinical 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 the design of SOP/Care Plans. Currently there are already numerous Practice Guidelines developed by experts in various fields (e.g. professional bodies or collaborative efforts) who have thorough understanding of clinical care processes and the modalities available for investigations, treatment and monitoring. Based on these, more precise plans for disease and patient groups can be deigned as SOP/Care Plans for a specific facility or practice.

TRANSFORMATION OF GUIDELINES INTO SOP/CARE PLAN

Clinical practice 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.

However, currently clinical practice guidelines are not available for all the types of diseases, illnesses or health problems. As such, managers need to work with care providers to develop guidelines and from them design SOP/Care Plans suitable for use in their of facility through consensus. They can use other sources such as recommendations (e.g. by WHO, the Ministry of Health) or the literature as the basis.

Validity of SOP/Care Plan

For the SOP/Care Plan to remain valid it has to be continually updated. The people in charge of producing them need to be constantly aware of recent developments.
Also the hospital need to ensure their dissemination and proper use both in terms of the adherence to them. It must also review their effectiveness in achieving intended objectives. The best way is to audit the SOP/Care Plan. Findings from the audit is then used to improve conformance as well as to rectify the structure and content of SOP/Care Plan itself.

INCORPORATION OF THE TOTAL PATIENT CARE CONCEPT (HOLISTIC CARE)

In the past care plans tend to focus on treatment. It is proposed here that the scope of the SOP/Care plan should be comprehensive and cohesive. Instead of ‘treatment’ the term ‘care’ is used to reflect this inclusiveness.

A comprehensive patient care plan based on the philosophy of Total Patient Care or holistic care should be adopted. 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”).The involvement of all relevant health care professionals encourages each of them to:

  1. be interested in the overall well-being of the patient,
  2. understand the overall care plan,
  3. be able to respond to a patient’s query regarding every 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 the realization of 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. guide to 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. To that end the clinical processes involved in ensuring successful outcome in patient care must to understood.

When building the SOP/Care Plans to be used by an organization these factors must be take into consideration:

  • goals of the organization in providing the service,
  • environment existing within it,
  • the resources available to it,
  • how service delivery is organized

Plans must match the capability of the organization or it must improve its status to meet the requirements.

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 or 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. The production system can be replicated easily at different locations. 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. Some service delivery systems can also be replicated as franchises (e.g. fast food outlets). The need for customization and personalization is more acute in healthcare services.

As such, the core SOP/Care Plan can be a general plan for a typical disease modified to suit the health care facility where it is to be applied. Variations in the disease itself can be anticipated and plans for its care can be written as extensions or appendices to this main SOP/Care Plan. Healthcare is geared towards solving problems both in the methodology used and the anticipated outcome. The nature of problems vary from disease to disease as well as case to case. When the variation is major, a separate SOP/Care Plan need to be written. Therefore, the SOP/Care Plan need to anticipate variations in the disease as well as eventualities in the care of the patient and provide solutions to them. Even so the SOP/Care Plan can only be a guide to performing the procedure. Additionally, another step, i.e. the conversion to the plan to the actual one to be used for the individual case is necessary.

CONVERSION OF SOP/CARE PLANS FOR USE ON AN INDIVIDUAL PATIENT

Varied Nature Of Service Products of Clinical Patient Care

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 particular 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 certain illness. Yet it is, to a certain extent, still generic and would need customization, by additions or omissions, when it is used as the 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 anticipated not only at the beginning of the service but also throughout the service delivery period because the patient’s condition often vary 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 OPERATNG PROCEDURE/CARE PLAN

In most industries, to produce products that are consistent, the SOP is used directly and exactly 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 give due consideration for the general needs of the patient (i.e. a sick person). These are often unique.

Hence, there should be a written SOP/Care plan to be used as a reference based on which the actual operating standards for a particular cased is devised.

Planning has always been regarded as an essential clinical process. Without a guide, the clinician thinks out the plan intuitively by applying his/her innate knowledge to the problem at hand. If the problem is common and familiar, he/she will repeat the plan that he/she has used before. However, often he/she may find his/her knowledge and experience inadequate to put together a solution for the problem at hand. The reference SOP/Care Plans fulfil the need for a reliable, comprehensive and easily applicable guide but must allow for flexibility during implementation.

Two Step Process In Implementing SOP/Care Plan: Reference vs Actual Plans

As discussed earlier the documented SOP/Care Plan cannot be used directly. Therefore, it is essential that planning of patient care follow a two step process i.e. choosing an appropriate plan as a guide (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 provided as a document for reference. To use it, the relevant part is modified and re-documented in the system controlling the operations of the service delivery (paper medical record or computerized information systems). The Actual OP/Care Plan is a statement of intent listing out the intended sets of tasks to be performed and their objectives (expected results or outcome). It is derived from the Reference Plan.

Therefore, 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 or Clinical Information System. For each case, the primary provider of care (usually the doctor in charge) acts as the leader and is the most suitable person to choose the appropriate Reference plan. However, there are exceptional instances when a practitioner from a different professional group make take the lead. Constructing the Actual plan is the joint responsibility of all the clinicians looking after the patient.

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 Operating Procedure/Care Plan to be implemented.

Use of the SOP/Care Plan as the Reference Plan

At the beginning, the efforts must be made within the healthcare facility to design standardized operating procedures or care plans that are generic in nature i.e. applicable to typical patients with a typical disease condition (rather than an individual patient). All such plans should be made available for reference (by whatever means) as a properly indexed comprehensive library of documents. The Reference plan for a particular case is selected from this library.

All aspects of care must be addressed at the time of the development and design of Reference Plans. As far as possible all objectives (outcome), policies and processes are thought out, eventualities anticipated and variations considered. As care of a patient is a multidisciplinary effort, each professional group should be involved. For example a section for nursing care should be included in the Reference plan. It should address the aspects of nursing required for the disease, illness or health problem for which the plan is written. There should not be a separate Nursing Care Plan standing on its own. The same is true for plans for rehabilitation or the care for psycho-social issues. (This is in contradistinction with current practice).

Reference plans form the basis for the planning of care of an individual patient. They give an overall and comprehensive view of the care to be given and the expected outcome. The care provider constantly refers to them as the care progresses. He/she needs to be aware of the various alternative plans available because even if he/she starts with a particular plan for a certain problem, he/she may have to choose alternative plans later.

Building Reference Plans for Different Stages

Choosing a Reference Plan From A Library Of Reference Care Plans
Conversion of Reference SOP/Care Plan to Actual OP/Care Plan

Building Reference Plans For Alternatives, Variations, Options and Contingencies

Care Plans are designed primarily 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.

Example: patient with polytrauma. Care of the General condition of the patient like loss of blood volume, breathing difficulty, impaired pulmonary function plus specific such as soft tissue injury, fractures, brain injury, organ damage, ischemia. Combinations, inclusion and exclusion, avoidance of repetition.

ELEMENTS TO BE CONSIDERED IN DEVELOPING SOP/CARE PLANS

The following elements need to be included in the structure and content of SOP/Care Plans:

  1. Identification of the needs of the patient
  2. Identifying the case type (Primary Diagnosis) Disease complexity (type, pathological grade)
    • Severity Level
    • Stage of the disease
    • Effects and complications of the disease
  3. Other needs arising from the patient’s health profile (preexisting disease, pre-morbid health status, demography)
  4. Care Objectives (expected outcome)
    • Cure
    • Containment (by 2O or 3O Prevention)
    • Palliation
  5. Procedures (Clinical Care Processes)
    • Information gathering
    • Deriving conclusions
    • Planning
    • Execution
    • Review/Evaluation (of diagnosis, objectives and plan)
  6. Policies (Legal, professional and ethical considerations)
  7. Break up the plan into phases of care
  8. Variation of care in response to:
    • changes in the certainty and comprehensiveness of the diagnosis
    • Progress of the disease along its natural history
    • Completion of the stage of the workflow
    • Other emerging issues (e.g. new issues such as complications and ineffectiveness of interventions)
  9. Guide to making decisions
  10. Reference documents providing guide to performing tasks or making decisions
  11. Quality control methods (methods to ensure conformance)
    • Preventive measures
    • Quality Measurement
    • Comparison with Standards
    • Detection of non-Conformance
    • Rectification and Damage control

The subject will be discussed in detail in another article.

Identification of Primary Needs of the Patient

Proper planning of care requires an understanding of the needs of the patient (defined as a person who is sick). Patients do not usually present to care-providers with readily identifiable health problems. Patients may or may not know what to expect from the care given. It is important to address their perceived needs but often they have unreasonable expectations or on the other hand have little hope. It is the responsibility of the health care professional to determine their real needs and what outcome can be expected. Therefore, before a service is provided, care providers need to gather information about the patient, analyze it and identify his/her problems. The primary needs relate to the disease, illness or health problem affecting the patient and are identified when an accurate and comprehensive diagnosis is known. Besides the main illness the patient often has secondary needs arising from concurrent illness, preexisting illnesses, unresolved previous illness, disabilities and other health problems. These are not the same for every patient and therefore cannot be anticipated but should be addressed during the actual planning of care. (Secondary and tertiary needs are discussed in another article).

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 and the expected outcome 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.

A SOP/Care Plan is designed and written for a defined service product. While the disease as described in a textbook usually encompass all presentations of it, different categories of the disease will be considered as different service products such that separate SOP/Care Plans or variations of it will be required for them.

Building Reference Plans for Different Stages

  1. Different levels of accuracy of the working diagnosis
    • Planning when the Diagnosis Is General or Uncertain (Symptom Complexes, Syndromes and Diagnostic Related Groups)
    • when a specific disease has been identified
      • main plan as applied to the typical disease
      • categorization, staging, pathological grading, severity level, risk stratification and level of remedy expected to be achieved.
      • sub-sets of plan for alternatives, variations, options and contingencies
  2. Phases
    • early
    • middle
    • later

Building Reference Plans for Different Levels of Accuracy of the Working Diagnosis

Clinicians used the term Working diagnosis to denote the diagnosis based on which the care is planned at the current time. This is the diagnosis that the criteria for selection of the SOP/Care Plan at any point during care. As the amount and quality of data is available to the clinician. the working diagnosis becomes more accurate changing from a broad or general diagnosis, to a presumptive diagnosis and then to a definite diagnosis.

This evolution also means that appropriate care must be instituted even when the definite diagnosis has not been identified with certainty. For the same reason, plans for care of a particular patient need to vary in specificity according to the changing levels of accuracy of the diagnosis.

The primary care provider (usually the doctor in charge) is the person responsible for arriving at the diagnosis. Therefore, he/she is also the person to select and initiate the care plan.

Planning when the Diagnosis Is General or Uncertain

At the initial phase of care 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. reason for visit
  2. symptom complex,
  3. a clinical syndrome or
  4. a diagnostic related group.
Working Diagnosis ObjectivesCare Plan
A. Symptom complex
B. Clinical Syndrome
C. Diagnostic Related Group
D. Clinical Syndrome
a. Symptom relief
b. Resuscitation
c. Stabilization
d. Obtain sufficient data
Care plan to
a. Determine Diagnosis
— Gather Clinical data
— Investigate
b. Early Treatment
— Relief symptom
— Restore function
— Stabilize
Care Plan for Various Certainty Levels of Working Diagnosis

Care Plan For Symptom Complexes, Syndromes And Diagnostic Related Groups

The diagnosis in the form of symptom complexes, syndromes and diagnostic related groups are made at the beginning of care, usually at the first visit. The SOP/Care plan then contains activities 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

Care Plans for an Specific Disease

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 care provider must 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.

Building Reference Plans For Alternatives, Variations, Options and Contingencies

Care Plans are designed primarily 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 change in diagnosis is minor then the same Reference plan is used but revised accordingly. If the diagnosis differs significantly, another more relevant Reference plan or sub-set of the previous plan must be chosen as a replacement. Hence, in designing the Reference Plan for a disease, besides constructing a plan for a typical presentation of the disease, it is necessary also to build in advance and make available appropriate plans for:

  1. the variant of the disease (pathological grade, clinical variant, acute, chronic)
  2. the stage of its natural history (early, late)
  3. severity grading (mild, moderate, severe)
  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 e.g. a concurrent illness or an active pre-existing illness, 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

Example: patient with polytrauma. Care of the General condition of the patient like loss of blood volume, breathing difficulty, impaired pulmonary function plus specific such as soft tissue injury, fractures, brain injury, organ damage, ischemia. Combinations, inclusion and exclusion, avoidance of repetition.

Working Diagnosis ObjectivesCare Plan
Specific Disease / Illness/ Health ProblemCure
or
Containment/Control
or
Palliation
Specific Care Plan to
– Confirm diagnosis
– Initiate plan
– Optimize care
– Maintain care
Care Plan for Various Certainty Levels of Working Diagnosis

Upside down: to redraw

Coopting Additional Care Providers

  • concurrent illnesses
  • pre-existing chronic illnesses and disabilities
  • unforeseen or peculiar complications of the illness or the treatment

A concurrent illness distinct from the primary current illness and a pre-existing chronic illness should be cared for using a Reference SOP/Care Plan written for it. Theoretically, the care has its own care episode. If special expertise is required for these and other peculiar problems, they should be referred to the relevant clinical department, unit or team and the responsibility for that aspect of care is transferred to them. Close communication, consultation and co-operation is required. The primary care provider would act as the coordinator and continue to be the leader.

If the Clinical Information System (CIS) is used, the finalized plan should be displayed as an integrated plan that can be viewed by all care providers concerned. The patient also should be aware of the plan, be allowed to make queries and be involved in it.

Planning when the Diagnosis Is General or Uncertain

Role of the Reason for Visit

For a new case the reason for visit is given by the patient as symptoms or just reasons. It may be apparent based on the referral letter.
In a follow up case, the reason for visit should have been known at the end of the previous visit and indicated in the appointment book, on the follow up card or discharge summary.

The value of symptoms as the reason for visit (in a new case) is weak because it is uninterpreted. It is of little value when given to the receptionist at registration or when seeking for an appointment over the phone. It’s value is better if the patient undergo a triage process by a care provider with clinical experience (e.g. nurse). Then, the symptom or complaint can be used to direct the patient to the right service provider (unit or department).
For a follow up case the reason for visit is clearer. It should have been decided before the discharge from the previous visit. Where a CIS is in place, it can be used to trigger a care plan .

Care Plan For Symptom Complexes, Syndromes And Diagnostic Related Groups

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 the specific disease can be chosen.

Care Plans for an Identified Disease

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 care provider must 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.

Working Diagnosis ObjectivesCare Plan
Specific Disease / Illness/ Health ProblemCure
or
Containment/Control
or
Palliation
Specific Care Plan to
– Confirm diagnosis
– Initiate plan
– Optimize care
– Maintain care
Care Plan for Various Certainty Levels of Working Diagnosis

SOP/Care Plan for the Latest Known Diagnosis (Working Diagnosis)

The SOP/Care Plan can be written for the main disease if it 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 have dissimilar characteristics requiring two separate SOP/Care Plans. It is not appropriate to write one for Diabetes.

Yet, quite often the diagnosis made refers to an entity that is a group of diseases rather than a distinct disease. For example, Pneumonia refers to a group of diseases characterized by infection of the lung consisting of Lobar pneumonia, Bronchopneumonia, 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 because it important to provide initial care of Pneumonia even when the cause is uncertain. Then specific SOP/Care Plans are required for its variants (based on causation) 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 will lead to a Definite diagnosis warranting a change in the plan. These developments include:

  1. emergence of new symptoms and signs,
  2. physiological changes evident by change in parameters monitored
  3. investigation findings
  4. better exposure e.g. at endoscopy or surgery
  5. variation in the response to treatment

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 between variants and the SOP/Care Plan associated with 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.
Care Plans for Variants of a Disease

Further Categorization of the Case

Cases can be categorized further according to possible factors that clarifies a diagnosis such as 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)

The above factors determine variations to the expected or desired outcome or in other words the end-product specifications.

Designing SOP/Care Plans for a Specific Disease

When the definite diagnosis of a specific disease is made with certainty, the guidance given in the SOP/Care Plan can be more certain, and specific. It will take a more didactic tone and be more regimented.

SOPs are often criticized for being rigid. In fact, by offering different directions and paths, the SOP/Care Plans can 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 (e.g. tests) or material (e.g. drug, suture) without major difference in effectiveness or safety, the care provider is given an option to choose one based on being the best suited, available or or according to the patient’s preference. 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.

Designing SOP/Care Plans for Variants of the Disease

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 depending on the circumstances:

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

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

Alternative SOP/Care Plans Corresponding to Variations in Patient Profile and Disease Pattern

Expressing Variations As Alternative Segments

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.

Expressing Variations as Separate Documents

When the variation in the case type and its care is distinct then separate SOP/Care Plans should be prpared. For example, Bronchial Asthma is categorized based on variation in acuity of onset into Acute exacerbations and Chronic (long term) presentations. The two categories are very different in the 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 the two categories with the common parts shared. Separate SOP/Care Plans 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 mode of treatment and intensity of monitoring. As such this variation in care of the disease sub-types is written as alternative segments/paragraphs (with headings) as shown below:

SOP for Varieties of Bronchial Asthma

Taking the Patient’s 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.

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

Taking The Patients Underlying Health Status (Health Profile) Into Consideration

If complete care is to be given, consideration should be given not only to the present illness but also health status before the illness began (pre-morbid status). It would not be necessary to design separate Reference plans to cater for these factors and circumstances. The exception is when they are inextricably linked i.e. one do not exist without the other). Instead, Normally, they need to be considered when the Actual plan is formulated. The Actual Plan should include additional actions in response to needs brought on by the following:

  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 OUTCOME GOALS ON THE DESIGN

The objectives of the service provided (i.e. care of the patient) should be determined and stated at the outset in the SOP/Care Plan if possible or at any point when the prognosis become clear. In fact, interim objectives are also determined for every phase of patient care. Also, 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 and prognosis becomes more certain, more definitive treatment is given and the objectives can be stated more clearly.

There are four main categories of treatment goals depending on the potential for altering the progress of the disease (the prognosis) 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
  4. Provision of comfort

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 reduced/mitigated/delayed. When there is potential for cure or complete resolution of the disease process, the plan is directed towards achieving it. In such illnesses achievement of the objectives is the marker for ending the care episode.
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. Achievement of the objectives mark the point when the care is considered to have been optimized.
Therefore, goals mentioned above 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. Prevent deterioration or recurrence
  6. Cure the disease (if possible)

Each mode of therapy needs to be planned so that the the outcome has the following quality features:

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

Therefore, setting objectives includes specifying standards of the final and also the intermediate outcomes of care based on the desired quality features. Adhering to SOP/Care Plan ensures that materials, methods and the resulting outcome are consistent. 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 requirements. 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

Work and Tasks

Work is the expenditure of energy to produce a useful outcome. It is made up of a series of procedures/tasks performed by workers. Similarly clinical care is a service made up of tasks. In industries other than healthcare, it is more common to use the word procedure instead of tasks.

Policies and Procedures

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.

Policies

Policies provide the limits or constraints whithin which procedures/tasks are performed. Policies are based on legal, professional and ethical considerations as well as rules dictated by the facility/organization where the service is provided.

Procedures

Use of the Term Tasks for Procedures

In healthcare, the word procedure is often used differently to mean some intervention done directly on the patient like a surgical operation, endoscopy, taking blood and so on. In this discussion, the term procedure is taken to mean, just as in other industries, a group of processes performed together to produce a certain output or outcome. To avoid ambiguity, the term task is taken to be equivalent to this meaning of procedure and is preferred in this discussion.

Performance of Tasks

In patient care, tasks are performed by workers delivering services who are called care providers. A service is made up of a series of planned tasks and their delivery. The instructions to perform tasks are called orders. Work can be done in many ways including:

  1. manually by the care provider or a team of care providers
  2. by the care provider with the help of machines.
  3. by a machine based on instructions given by a worker and under his/her supervision
  4. entirely (automatically) by a machine prompted by instructions built in computer applications

As part of the service, items such as drugs, blood products, fluid and nourishment are given or supplied to patients. These tasks must be done in an accepted way. They are often called dispensing or administration.

Processes

Tasks are made up of processes. In caring for a patient, healthcare professionals act as a team. They are dependent on the contributions provided by each another.

Relationship between Input, Processes and Output

A task can be performed only by a worker with the skill and knowledge to perform it. Even then, he/she must do so using the right input and within a suitable environment. Input includes items such as raw material, instruments, assistance and information. In fact, the ability to proceed from one task to the next depends on whether the results of the transformation made by the previous task is immediately available and sufficient. If so, he/she may continue to the next task without pause. Therefore, an essential input is data (results) generated by the previous task.
The environment suitable for a task takes into consideration situations such as the adequacy of space, cleanliness, air quality, safety, lighting, noise level, presence of essential equipment and proximity to other facilities.

Transformation of Input by Processes into Output

Description of Tasks in the SOP/Care Plans

Universally in modern healthcare practice, clinical care providers, including doctors, nurses, allied health personnel and other professionals, follow a commonly agreed way of delivering care.

Types of Tasks in Patient Care

Tasks occur in sequential segments termed as phases. The phases of care of both acute and also chronic diseases are categorized into phases for the purposes of:

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

Tasks are performed in many ways, using various input. Many are technical i.e. performed manually or with the help of machines. Some take the form thinking (cognitive) processes but most are a mix of both types of processes.

To implement the SOP/Care plan, it is essential that the list of tasks (task lists) 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. Generation, gathering and collection of data about the patient’s illness and the effect on his/her health through interview, examination, observation, measurement, tests and investigations by various techniques,
  3. Documentation of data regarding tasks done and their results plus reporting incidents that happen and the actions taken (using specific forms and charts).
  4. Analysis and interpretation of data to determine the diagnosis, status, profile and needs of patients,
  5. Planning the case management including response to anticipated side effects,
  6. Therapeutic tasks (treatment, providing support, rehabilitation, preventive actions, damage control) using various modalities.

Because functions are performed by persons with the ability to perform them, tasks are allocated according to professional groups or teams as task lists.

Workflow

Workflow is the predicted or planned sequence and direction and layout of what, when and how work processes are to be done. Usually, the workflow advances in stages as and when all tasks planned for a stage are completed and the objectives are met.
Workflow is the practical way work is done based on algorithms which refers to the flow of thought. Clinical pathway is another term for workflow and when it is used in patient-care activities. The two terms has been used interchangeably. If the term care pathway is to be used at all it should be synonymous with workflow as used in SOPs of other industries. The use of it to mean care plans is incorrect.

In the SOP/Care Plan, the path/flow/sequence/layout of clinical processes is presented in two ways i.e.:

  1. written as a narrative,
  2. depicted graphically as a chart

Description of the Flow Of The Clinical Process

The workflow is first expressed in narrative form. It describes the arrangement of the tasks for the delivery of a service in terms of content, layout, sequence and direction. The operational policies are embedded within it.

A general outline of the workflow is often called the high level workflow or ‘critical’ pathway. It contains only the critical (important, required) steps) with the obvious or mundane steps left out in the documentation (but not in practice). When the processes are complex it is beneficial for better understanding to demonstrate the flow initially in the form of an outline and details are elaborated subsequently. The outline of the generic flow of clinical care is as shown below:

Outline of the Sequence of Work Process

This general workflow is applicable to most cases. However the sequence of the processes does not necessarily follow this strictly but will depend very much on the type, severity, urgency, speed of 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 investigations. 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.

In some instances the following scenarios that affect workflow can occur:

  1. results of tasks are available or become evident only after an interval,
  2. the next transformation must be performed performed by another worker.

For the first scenario, the care provider has to stop, wait for the results and resume his/her work when they are ready. For the second scenario he/she has to pass on the next task to another worker. He/she may resume his/her part of the work when the transformation has occurred or the results are ready.

The workflow has decision making steps i.e. points when care providers have to choose the appropriate path when alternative directions exist. The decision is guided by criteria such as:

  • policies,
  • judgement,
  • patient preference,
  • availability of resources.

Graphical Depiction of the Flow Of The Clinical Process

In the SOP/Care Plan, the understanding of the flow, sequence and layout of clinical processes is much enhanced if depicted graphically as a workflow chart. However, it must always be preceded or followed by a narrative description. The workflow that can be applied generically for patient care is as depicted below:

Decision Making Steps an Essential Component of the Workflow

Decision making steps is an essential component of the workflow because its determine the direction of the steps of the care process.

In clinical care, the plan is very much dependent on diagnosis. After selecting a plan based on the initial diagnosis, the care provider may decide to alter or revise the plan based on the criteria listed below:

  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 flow of clinical processes,
  4. Occurrence of other emerging issues (incidents, contingencies)

There are instances when the workflow cannot progress according to the initial plan due to various impediments or circumstances. At times, the processes e.g. information gathering, investigations or tasks 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.

Decision-Making and the Resultant Change in Plan

Decisions are made when there are choices or options to be selected. In clinical care, decisions are made based on conclusions arrived after appraising the situation based on accumulated information. The conclusion may be determined by appraisal of:

  1. the updated working diagnosis
  2. the latest understanding of the disease/problem,
  3. the evolving objectives of care,
  4. the progress of the disease,
  5. the response to treatment.

The choices or options that a care provider can make are:

  1. to retain the current plan without alteration,
  2. to make modifications to the current plan,
  3. to change the plan completely to a new plan.

Changing To an Alternative Reference Care Plan In Response To Variations, Options and Contingencies

At the start of care (usually at the first session) the primary provider chooses a care plan that matches the diagnosis. At subsequent sessions 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 formally designed plans are not available, then the care provider needs to devise the actual plans him/herself without referring to a Reference plan. Hence, it is better to design and put together a comprehensive library of Reference Care Plans to cater for various scenarios in the care of a patient for each disease, illness or health problem. The primary provider selects the appropriate plan from a library of SOP/Care Plans made available to him/her.

DIVIDING CLINICAL PATIENT CARE INTO SEQUENTIAL SEGMENTS OF ACTIVITIES

In any manufacturing industry, producing the output is achieved through many separate activities, that usually include processing of the raw material, fabrication of parts, assembly, testing and distribution. The activities are usually performed in a logical sequence. For some of the activities, the processes must be strictly continuous e.g. in an assembly line, but in others there can be intervals in between and done concurrently at different facilities.

The Care Episode

The entire period during which care is delivered is termed as the Care episode, It mirrors the disease episode. It begins at the time of first contact with a health care practitioner and ends, in most cases, with the resolution of the illness/problem or death of the patient. More than just thinking of it as a period of time it is necessary to view the care episode from separate angles:

  1. the service product
  2. the scope of a particular SOP/Care Plan

Besides what is delivered to the patient, what he/she experiences during the care episode is also the service product. How the service is delivered is described by the SOP/Care Plan designed for it.

Conceptual Division of Care into Phases

In the delivery of patient care, work is divided into into sequential stages better termed as ‘phases’. A phase is a portion of the care episode within which certain sets of activities directed towards achieving one or more objectives are carried out. The final outcome of the care episode is achieved through the fulfillment of objectives of each phase through the performance of a complex set of tasks. In the SOP/Care plan document, this complexity can be clarified by dividing the description of care into different sections and paragraphs differentiated by headings.

Iterative Nature of the Workflow

The scope of work and the degree of difficulty in carrying them out varies significantly for different phases and so does the duration. However, even though the objectives of care for each phase are different, the types of activities to achieve them are almost similar. During the care episode and even at every phase of care, the steps of interview, examination, tests, diagnosis, plan and evaluation often forms a cycle that is repeated. This is necessary because clinical patient care mirrors the steps of data management which is made up of:

  • gathering data,
  • putting them together,
  • analyzing them,
  • interpreting them,
  • deriving conclusions based on them, and
  • acting on those conclusions.

Actions will generate more data, the management of which will undergo similar steps. Results of analysis, interpretation, conclusions and actions becomes new data.
Furthermore within the phase itself, some work may have to be repeated until satisfactory outcomes or results are obtained. Repetition is required in circumstances when:

  1. the work is effective only if it is repeated intentionally for a certain number of times
  2. failure to obtained satisfactory result by a single instance
  3. the work has not been carried out properly
  4. the patient’s condition changes as the disease progresses naturally or because of treatment. Repetition of monitoring of parameters, tests, progress review and measurement of outcome will provide data that will show the trend,

The repetition of the clinical care processes makes the work cyclical. Each cycle is termed as an iteration and clinical care is said to be iterative in nature.

Iterative Nature of Clinical Processes

In the Actual plan, if the work needs to be 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”. However, since tasks are performed based on instructions or orders, new ones have to be made if the valid duration of the initial order has lapsed.

Activities within a Phase

Within a phase, the ability to perform each task is dependent on the outcome of the previous task. Therefore as a rule, it is important to perform the set of tasks in sequence.
However, this sequence may not be strictly followed because there are times when:

  • an opportunity to perform the task may not occur again,
  • it is more convenient to perform an activity earlier or later,
  • one activity may be given priority over another because of certain needs.

When designing the SOP/Care Plan, it is necessary to think out and list down the whole series of tasks within the care episode. It may be appropriate to depict them as a single list of tasks in the Reference Plan but as will be discussed later, in the Actual Plan the tasks have to be divided into sets or blocks of tasks so that they can be allocated time slots and assigned to particular care providers. Unlike in manufacturing industries, at the time of designing the Reference SOP/Care Plan, the separation into discrete blocks is not possible because of the the following reasons:

  1. in patient care, an activity need not be carried out at the same location or facility,
  2. alternative equipment may be used to perform certain tasks,
  3. the ability to perform a task is not necessarily confined to a particular care provider category,
  4. often there is a need to repeat the tasks before the desired outcome is achieved, The frequency of this repetition is not predictable.
  5. clinical tasks of data gathering, diagnose, plan, treat, monitor and reevaluate take a variable amount of time to complete.
  6. the advancement of the care process is related to how the disease progresses which is not always the same,
  7. the response to treatment is not uniformly predictable.

Therefore, based on the concept of phases of care, clinical care activities in the Reference SOP/Care Plan are divided into varying segments.

Documenting the Reference SOP/Care Plan into Segments Corresponding to Phases of Care

As discussed earlier the SOP/Care Plan is designed to cover the entire episode of care. The primary division of the care episode is into sequential phases of the clinical care process with each phase aimed at achieving defined purposes or objectives. A phase starts with the setting up of one or more objectives and ends when all the objectives have been met. This occurs when all the tasks designed to achieve it are performed. Completing all the segments will then result in the final outcome.

For simplicity, the phases can be divided and sequenced into early, intermediate and later parts. The distinction between phases is in their main objectives. 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 its outcome. This is followed by efforts at continuation or maintenance of treatment, monitoring and reassessment. Subsequent actions depend on whether the illness resolves such that care can be terminated or remain unresolved hence requiring continued care.

Indeed, phases can be divided in different ways depending on the type of service. They can be given different names but the following division is typical:

  1. Phase of determining the diagnosis and immediate care / early treatment
    • initial data gathering
    • determination of diagnosis
    • immediate or early care
  2. Phase of initiation of definitive care
  3. Phase of optimization of care
  4. Phase of maintenance of care
  5. Phase of resolution (continuation or discontinuation of care)

How the clinical care processes are segmented into phases is depicted below:

Proceeding from one phase to the next depends on whether the objectives of the former have been achieved. In an emergency case, the initial phases are compressed such that tasks within them such as resuscitation and stabilization are accomplished within a short period. In non-urgent cases the phases are stretched over a longer period.

Even though tasks are performed to achieve the objectives of a phase, it does not mean they are discontinued at the completion of a phase. Many tasks must be continued to maintain the gain achieved. For example, the initil data gathering is followed intermittently by progress assessment. Symptom relief may be necessary even at later phases or even permanently. Monitoring is done continuously. Stabilization and optimization must be upheld and not allowed to slide.

How the care episode is divided into phases is depicted below:

Division of Patient Care Activities into Phases

Documenting the Reference SOP/Care Plan into Segments Corresponding to Phases of Care

Cases can be categorized into acute or chronic categories. Each categories can be divide further into sub-types based on severity, grading, stage at presentation, and response to treatment. The differences of their care is mainly in the mode of treatment and intensity of monitoring. As such this variation in care of the disease sub-types is written in the document as alternative segments designated by sections and paragraphs (with headings) as shown below:

As stated earlier, main segments relate to ‘phases’. In the Reference SOP/Care Plan document, phase can be presented as distinct sections and paragraphs with appropriate headings. Each segment is divided further into groups of tasks as will be discussed later.

  • Care episode
    • Phases

Selection of / Content of Each Segment of the SOP/Care Plan

Since moving on from one phase to the next depends on whether all tasks has been performed and the objectives have been met, the content of each phase need to be determined with this consideration in mind. There may be occasions when tasks of one phase is carried over to the next. Some tasks like monitoring persists through out the phases. Adoption of the division into phases is critical in determining the structure and content of the SOP/Care plan.

  • Care episode
    • Phases
      • Clinical Care Processes

Phase of Determining the Diagnosis and Early Treatment

This is the phase of initial contact with a health care provider. It is in two parts with both running concurrently.
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. Early treatment is given based on the working diagnosis (symptom complex, clinical syndrome, diagnostic related group) even as efforts at determining the definite diagnosis are being made.

Formulation of Diagnosis

The main objective of this phase is to determine the diagnosis as accurately and comprehensively as possible. For a new case where the diagnosis is not known, steps are taken to identify it. This process can be termed as the formulation of the diagnosis. Hence, the initial steps in this phase are:

  • clinical data gathering (interview and examination)
  • performing simple tests
  • initiation of observations and monitoring
  • determining the working diagnosis
  • Care episode
    • Phases
      • Clinical Care Processes
        • Data gathering
        • Determination of Diagnosis
        • Planning
        • Execution of plan (treatment, monitoring)
        • Review of outcome, treatment, diagnosis and plan
        • Continuation or discontinuation

At the beginning a clinician takes charge of the case and is said to be the primary provider. Usually this person is the doctor to whom the case is assigned. However, depending on the scope of care, he/she can be a nurse, nurse practitioner, therapist, or clinical psychologist. The primary provider is responsible for formulating the diagnosis. The Working diagnosis determines the care plan to be selected and used.

Process of Determining the Definitive Diagnosis

The provisional diagnosis will provide a guide to the next step which consists of:

  • taking a more elaborate history
  • finding out more about specific symptoms
  • closer examination of regions or organs involved
  • performing more specific and elaborate diagnostic investigations
  • analysis and interpretation of all data available to formulate the definitive diagnosis

The clinician in charge uses the data from tests, observation and the monitoring to arrive at the definite diagnosis. The diagnosis need to be further refined to clarify the variant of disease, severity grade, stage of illness, risk stratification and prognosis. Investigations are aimed at determining the patient’s general physiological status and functions of various systems besides aiming initially to determine the system or site involved or the likely pathology but in the end to determine the definitive diagnosis. Providers of clinical support services become involved when diagnostic investigations are ordered.

The definite diagnosis is one that is both specific and certain. Often, the effort to determine it takes time. This phase may be completed over a few sessions with intervals between the sessions. This is necessary because the results of pertinent tests and observations are not immediately available but are obtained at different times and have to be accumulated. analyzed and interpreted before the conclusion is made regarding the diagnosis. Depending on results additional tests may have to be done.

However, every effort must be made to obtain a definitive diagnosis becuase it indicates the cause of the disease or at least the pathological processes that are affecting the patient. This information is necessary before the plan for specific treatment can be made. In fact this phase ends only when a reliable working diagnosis is arrived at.

Immediate Care and Early Treatment

Therapy must not wait for want of an accurate diagnosis. Immediate care and early treatment is based on the Working diagnosis which at this point of care is provisional in nature and are likely to be:

  • a symptom complex
  • a clinical syndrome
  • a disease identified to belong to a diagnostic related group

The care provider has to obtain guidance from the SOP/Care plans prepared for these levels of diagnoses. Only occasionally, the specific diagnosis is obvious from the start.

Generally in both acute and chronic illness, efforts at the immediate phase are directed towards;

  1. nursing care
  2. immediate and continued relief of symptoms
  3. monitoring of relevant parameters
  4. maintaining normal physiology through resuscitation and stabilization
  5. providing nutrition or at least fluids and electrolytes,
  6. giving support (physiological, psychological, social and spiritual)
  7. taking preventive actions
  8. avoiding and reducing emergence of disability
  9. treatment of ongoing problem as they arise

The difference in approach between acute and chronic illness is a matter of intensity and priority. In an acute illness resuscitation, stabilization of physiological parameters and support of their functions must be done quickly., In a chronic illness these can be done in a more measured manner.

Phase For Initiation Of Definitive Care

This phase is a direct continuation of the previous phase. Only when the diagnosis is definite can the direction of care be set clearly. The care provider chooses the care plan designed for the specific disease, illness or health problem.. As such, the guidance given in the SOP/Care Plan can be more certain, and specific. It will take a more didactic tone and be more regimented. From this point the care for the rest of episode may be planned, initiated, optimized and maintained clearly.

Selection of Care Plan based on Definite Diagnosis

The definite diagnosis allows the care provider to clarify the objectives of care (expected outcome, therapeutic end points). A more definite SOP/Care Plan appropriate to the diagnosis is then chosen and customized. Even so, further efforts are made to refine the diagnosis to clarify the variant of disease, severity, grade, stage of illness, risk and expected or desired outcome. In this way more relevant plans can be chosen and implemented as care progresses.

Even when the diagnosis is certain, unexpected developments, eventualities and contingencies can occur. The workflow may take variable paths consequent to decisions made. Because of that, the plan for the latter stages can only be anticipated.

Even though the condition of the patient may have been stabilized, tasks like nursing care, symptom relief, monitoring, support and others initiated earlier must be continued. At the outset, regular observations and monitoring are initiated.

Setting the Objectives of Care

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 the combination of any of the following:

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

An appropriate definitive management plan consistent with the care objectives is adopted and implemented. As such, the care provider defines the treatment end points, chooses the plan offering the most suitable treatment approaches or modalities. In this phase and in later phases. measurements are made to determine whether these end-points have been achieved. The progress of the patient is reviewed regularly to detect deterioration or improvement and occurrence of complications of illness or treatment.
Depending on the illness, this phase may spread over a considerable period. In the case of an acute illness, efforts should be made to complete this phase at the initial visit but it may be necessary to have the patient discharged from in-patient care and to complete it in the outpatient setting. For less acute cases this phase may be carried out entirely over a few outpatient visits.

In this phase almost all care providers are involved directly or indirectly in the care and would have their own share of tasks which are listed in their Task lists. These tasks include:

  • review of data
  • ascertain diagnosis
  • choose and execute appropriate plan
  • start definitive treatment
  • initiate rehabilitation
  • provide education and counseling

The tasks involved and their sequence is as shown below:

Phase of Optimization of Care

The main aim of this phase is to optimize the benefit of care given. The care provider need to be constantly aware of the desired treatment end points make diligent efforts to achieve them.

Progress is assesed through:

Assessment should address both the progress of the disease and effect of treatment. The outcome of the efforts made will reveal the behavior of the disease and improvement or otherwise of the health of the patient. Conformance of the care providers to the plan must be assured through quality control measures. Compliance of patients to instructions must also be assessed and enforced. 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.

The phase may extend beyond one session. If the the patient is at first managed as an inpatient he/she may be discharged and the care continues in the outpatient setting. The progress of acute illness is often dramatic and easily discernible. The progress of chronic diseases vary in many ways including:

  1. slower speed of deterioration or improvement ,
  2. active vs inactive periods (remission, reactivation),
  3. emergence of complications of the disease

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. If the progress is satisfactory, the plan is continued with further improvement if necessary. However, if it appears to be ineffective, minor or major modifications must be made. If there is doubt regarding the diagnosis further investigations must be done, If the diagnosis is different, a new care plan need to be initiated and optimized.
Optimization is considered achieved when the care regimen produces the best possible level of benefit. The plan is then continued.

Phase of Optimization of Care

Phase of Maintenance of Care

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. It must be noted that a phase may need more than one visit to complete.

The plan of care that led to the optimal level of outcome must be maintained. Depending on the illness, this phase may extend over a considerable period. Usually it is conveniently carried out at outpatient settings (clinics, day, care, home care, teleconsultation. self care).

The care provider is expected to follow the established care regimen as closely as is possible. At the same time, an important aspect of the plan is the continued evaluation of response to and effects of therapy. The following factors are assessed:

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

The progress of the patient is reviewed regularly to detect deterioration or improvement and the occurrence of complications of illness or treatment. An important aspect of this pahse is determining the approprite intervals between reviews.
The effectiveness of the care given may not be maintained for reasons of:

  • poor compliance,
  • change in the disease,
  • change in the patient’s general health

The care provider may have to revise the SOP/Care Plan and modify the treatment accordingly. Also, he/she should consider reviewing the diagnosis especially in terms of the severity and grading which would then require modification of the objectives and the plan. It is also possible that failure to achieve favourable outcome, even at this stage, may be due to a wrong diagnosis.

For illnesses that has been brought under control, the care provider must be on the look out for recurrence.

Phase of Maintenance of Care

Phase of Resolution (Continuation or Discontinuation of Care)

It is essential that the care provider ensure the continuity of care. There may be opportunities to reduce attendance at the health care facility, One way is to continue care via home care or teleconsultation. The primary provider may delegate the responsibility to care providers at other facilities for the convenience of the patient. The primary care doctor, family doctor or school/factory nurse and voluntary bodies are the most appropriate care providers to take on this responsibility. With regards disability or handicaps, therapists, counselors, optometrists, audiologists or social workers may be more appropriate. Indeed for most cases care is not really discontinued but continued by self-care. Therefore at discharge from the care episode, patients must be given adequate education on how they can maintain their health. They should be encouraged to return to the facility or seek the help of any other health care professionals if they are unwell or their health deteriorates.

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.

Depending on the nature of the illness and the response to care, the service may reach a stage where it can be discontinued. This is so with cuarable diseases.

On the other hand, chronic illnesses are characterized usually by continuous progression or persistence. The duration of care is therefore long term and usually extend throughout the life of the individual. Some diseases may resolve, go into remission and be dormant only to appear again later. Temporary cessation of therapy with planned follow up reviews at longer intervals (quarterly, half yearly, or yearly) may be necessary.
Some diseases may not require care at health care facilities but sufficiently managed by self care. Rarely some chronic diseases runs through its course and dissipates. The care can then be phased out.

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

For illnesses that has been brought under control the care provider must be on the look out for recurrence.

On the other hand, a acute illness/health problem that has dissipated 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, handicaps or inconvenience. In all these instances, long term care will then be planned and provided.

The circumstances that allow care to advance to the next phase often become evident when actual care is given and the care provider has reviewed whether all efforts planned has been performed and after the outcome of tasks are known. Hence it will be discussed in the discussion on the Actual OP/Care Plan.

Documenting Phases as Segments of the Reference SOP/Care Plan

The Reference plan document should be divided into segments consistent with phases with each segment indicating the sets of clinical care processes to be performed. The care provider must be aware of the phase of care that he/she is currently in. If the Reference DOP/Care Plan is written on paper, each segment need to be marked out clearly as paragraphs with clear headings. In a computerized system, it is possible for the relevant segment to be called for (via a menu) or be automatically presented to the care provider at the appropriate time.

How the structure and content of the SOP/Care Plan is segmented in accordance with phases is shown below:

Content of Various Phases of Care

The decision to progress from one phase to the next is a decision-making process requiring much thought, In a computerized system, the criteria to indicate the right moment to move on is the fulfilment of objectives based on data regarding progress and outcome. Even then, the decision remains the responsibility of the care provider. Completion of a phase may require a variable number of sessions and hence cannot be scheduled in advance.

B. PRACTICAL APPLICATION

Steps in the Practical Application

Steps in the practical application

  1. selection of the reference SOP/Care Plan as the standard to be followed
  2. conversion to actual plan
  3. dissemination
  4. ensuring conformance / adherence to it
  5. measurement of the quality of the intermediate and the final product
  6. continual improvement of processes and outcome
  7. putting in place remedial measures when necessary

CREATION OF ACTUAL PLANS

Actual Plans in Paper-Based System

Use with Paper Record Systems

If the Reference plan is made available on paper (e.g. a booklet or manual), It is used as a source of reference i.e. as a guide in ensuring that uniform policies and procedures are followed and as a source of knowledge. To construct the Actual plan, the provider need to read the relevant parts, at the point when planning is required, transform it in his mind or jot it on a piece of paper before transcribing (rewriting) it onto the case notes (paper medical record) as instructions. Obviously, this is a laborious method and is the reason why attempts at using care plans (e.g. by nurses) have met with limited success. It works only if the care provider is very familiar with the plan to the extent he/she has it in memory and can construct the actual plan on the go.

If the plan is provided as a document on a stand-alone personal computer, a word processor can be used to copy-paste the relevant part and edited to construct an actual plan. The resulting document can be printed and then incorporated as part of the paper medical record or otherwise transcribed in writing. Printing is more convenient but depends on the availability of a printer.

Use in Computerized Information Systems

The advent of computerized information systems (Hospital Information System, Clinical Information System), provides the most effective mechanism to put SOP/Care Plans to practical use., A complete list of various SOP/Care Plan reference documents can be stored in a file-server and provided as part of the application software. Care providers can look for, select, call for the relevant plan via links through a search mechanism or from a drop down menu and read it. More importantly, it is possible to build into the system the means to actualize the plan. The system can be made to provide the relevant part of the plan at the opportune moment in the care of the patient. The primary trigger of a plan would be the diagnosis. If diagnosis is taken to include reason for visit, symptom complexes and clinical syndromes, then the system can suggest a plan even at an early stage (e.g. at triage). As data indicating diagnosis is entered, the system can present relevant plan to the care provider. Once the diagnosis is established and based on the data that has been collected the Clinical Information System could be made to be aware of which phase of care is being carried out and present the relevant part of the plan. The care provider can then modify the part presented by adding or removing various elements of care. Based on analysis of the current data, the system itself can make changes automatically e.g. perform a reconciliation by omitting redundancies. As changes in the diagnosis is documented by the care provider, the system suggests a different plan accordingly.
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. (The use of the SOP/Care Plans in a computerized system is described briefly in this article but will be discussed in another article yet to be written).

TECHNIQUE OF CONVERTING REFERENCE PLANS INTO ACTUAL OP/CARE PLANS

The Actual OP/Care Plan is a statement of intent listing out the intended sets of tasks to be performed and their objectives (expected results or outcome). It is derived from the Reference Plan but take practical matters into consideration. Conversion of the Reference plan to the Actual plan is performed on demand in batches based on the stages or phases of the care process.
In a paper-based system, the plan takes the form of instructions documented in the medical record regarding tasks to be performed for all aspects of care including investigations, monitoring, and various types of treatment such as nursing care, medication, procedures, rehabilitation, counseling, psycho-social aid etc.

The SOP/Care plan remains as a reference document until it is converted into an plan for the individual patient. Once selected, it becomes the basic plan that can be customized by adding or removing certain elements before being accepted and used. Because the patient’s needs change with his/her condition (diagnosis, additional problems), a complete Actual plan cannot be prepared in advance, in one go. The conversion of the plan has to be done in parts in a stepwise fashion (will be discussed later).

Actual Plans in Paper-Based System

Traditionally, the actual plan is documented as shown below:

Traditional Way of Writing Plans

Planning should be considered as a distinct and separate task. Data concerning it, should be recorded at the time when the plan is generated together with other related tasks in chronological order. Currently, there is a practice of using a separate table to record the plan together with assessment, tasks performed and outcome achieved, in the case notes. Putting these together in one table is incorrect because those activities occur at different time periods. Instead, the execution of the plan (the treatment given), and the results obtained are documented, as and when the processes are performed, in progress review notes, monitoring charts, procedure records, findings, outcome documentation and etc.

Incorrect Way of Documenting Care Plan

Plans are executed as orders written in the medical record. The orders are then rewritten on Order sheets which are passed to the relevant unit or person who is supposed to carry them out. Results are returned on result sheets which are appended to the main record. Monitoring data is recorded on separate charts which are compiled together with compiled with the main records at discharge. The practice of writing Nursing notes on separate charts should not be condoned.

Actual Plans in a Computerized System

In a completely computerized system, the relevant parts of the the reference plan required at that point of care can be accessed manually (in a paper-based system) or be given automatically (triggered) by the computerized system based on rules. The reference plan is meant to be read and understood. To execute it, a relevant section of it is obtained or provided at a visit or event. The Clinical Information System software can be designed to make it possible for care providers to modify and transform the relevant parts of the chosen Reference plan into an Actual plan. No transcription is necessary. The plan is then converted into orders (orders list) and tasks to be executed (task lists). When the plan is executed, data regarding task performance and results achieved can be entered in data entry forms as and when they occur 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.

The Reference plans have alternative sections for anticipated variations in the progress of the case. When faced with these variations the care-provider decides on which alternative to take. If the right step to be taken is not available in the Reference plan, then the care provider needs to devise the actions him/herself. Therefore, to minimize this need, it would be helpful if the design of each SOP/Care Plan takes into consideration the possible scenarios that can happen in the care of a patient.
Plans are executed via the Order entry (CPOE) application and results are displayed as views. It will be added to the to the medical record in chronological order.

Responsibility and Leadership in Selecting the Appropriate Plan

Although the care of a patient is a multidisciplinary effort, selection of the appropriate plan rests on the care provider deemed to be the leader at that stage of care, The stage may or may not correspond to the phase of care. By convention, the authority to select the plan is given to the primary provider of care. Even though in most instances, this person is usually the doctor in-charge, it is not applicable at all stages of care. The person taking on the role of the primary provider may change depending on the circumstances. The responsibility may or may not be be obvious when preparing the Reference plan but has to be decided in the Actual plan. At the early stage e.g. the triage stage, the attending care provider (not necessarily a doctor) will have to select the appropriate plan and execute it. This is facilitated by the availability of Reference Plans for diagnosis at the level of symptom complexes and clinical syndromes. Subsequently, the responsibility of care is passed on to a care provider who have the necessary expertise to elucidate a more definite diagnosis. Based on the diagnosis he/she decides whether to continue the care or pass on (refer) the case to the appropriate care provider or care team (department of unit) with the necessary capability. From then on the care provider in-charge has the authority and responsibility to change or modify the plan.

When the actual plan has been formulated, it is then communicated to other care providers by documenting it in the medical record/case notes or the Clinical Information System (presented under the section for Plan). Major deviations from the chosen Reference plan (variance) must be explained and documented. Medical insurance companies seem to think that the SOP/Care Plan has to be followed to the letter. This is not consistent with actual clinical practice. To avoid having to to write tedious variance reports to convince them, alternatives, allowed variances and peculiar situations where they can be applied should be included as part of the Reference SOP/Care Plan. Obviously these cannot be exhaustive.
The details of the plan for the entire care episode is described in the Reference SOP/Care Plan which should be referred to rather than copied onto the case notes/medical record/CIS. Instead, a statement as to which SOP/Care Plan has been chosen is indicated e.g. “to treat patient as case of Acute Coronary Syndrome”. Members of the care team will then become aware of the general approach to the care planned. The actual plan is written in the medical record/case note or entered into the CIS. However, because the entire plan cannot be decided in advance only the parts that is certain i.e. the next set of tasks is documented.

Role and Responsibilities of Members of the Care Team

Since the care of a patient is a multidisciplinary effort, SOP/Care Plan should indicate the roles and responsibilities of care providers expected to be involved in the care of a particular type of case.
When the Actual plan is formulated, each category of care provider is given the opportunity of modifying the relevant part of the chosen Reference plan pertaining to his/her area of responsibility. For example nurses should be able to formulate the Nursing care plan.. They should make good use of their expertise to modify the relevant portion of the plan as long as it stays true to what is prescribed in the chosen Reference plan. Yet, there should be consultation with other members of the care team.

There are situations, when other care providers with special expertise (outside of the core team) may be invited to be involved ad hoc in the care of the patient, through referrals or consultations. Such instances will occur for instance when there are:

As discussed above, the entire care processes within the care episode are divided into segments consistent with phases, This division is conceptual. They are not practical for the purpose of dividing the episode into tangible service entities because phases:

  1. have variable content,
  2. take variable duration to complete,
  3. have no fixed start and end time,
  4. not necessarily completed at a fixed location,
  5. not necessarily allocated to a specific person or team/department/unit.

Hence, a suitable business model has to be developed. The word business here does not have commercial implications but refers to an organized activity aimed at a fruitful outcome.

The Business Model for Patient Care Services

Although the clinical care processes described earlier are conceptual rather than practical, they form the rationale and backdrop for the establishment of a business model for the delivery of patient care. The business model must expanded to include responses catering to the patient’s primary needs as well as the secondary and tertiary needs. Besides emphasizing effectiveness and safety as the main goals, efforts must also be directed towards ensuring:

  • accessibility,
  • efficiency,
  • responsiveness,
  • acceptability,
  • convenience and,
  • cost-effectiveness.

Patient care must be organized as a business with the patient considered as a client.

To provide care in a practical way, it must be given as a package consisting of a defined set of service items at defined locations and time periods. Unlike in other industries the items in the contents of the package are variable rather than fixed.

Blocks of Tasks as Commercial Packages

Grouping tasks into packages provides the means to arrive at figures for costing, charging and remuneration.

When the SOP/Care Plan is used, the care of various types of patients is considered as different service products, From a business standpoint the entire period during which the service product is delivered is a care episode and all the tasks performed and input provided can be considered as a commercial service package. The episode consists of visits and therefore the entire package can be broken down into groups of tasks performed during each visit which can be considered as smaller packages. This provides the basis for clarifying:

  1. the services that the patient is entitled to,
  2. the services that ought to be provided by the healthcare facility,
  3. share of tasks conducted by each department/unit/care provider

The Patient as a Client

A patient is a person who seeks services from a healthcare facility or a care giver for the care of an illness, disease or health problem. To receive care he/she must be formally enrolled as a client following which he/she is considered as a case.

DIVIDING CLINICAL PATIENT CARE INTO BLOCKS OF ACTIVITIES

In any manufacturing industry, producing the output is achieved through many separate activities. that usually include processing of the raw material, fabrication of parts, assembly, testing and distribution. The activities are usually in sequence but parts may be built separately before being assembled. For some of the activities, the processes are strictly continuous e.g. in an assembly line, but in others these can performed with intervals in between and done at different facilities.
Services in healthcare are delivered in a similar way. The entire Care Episode is considered as as a package of services. They are offered as sessions consisting of sets or blocks of activities.

The order by which set of steps or the workflow performed by care providers can be unfamiliar to persons from other professions. To explain them, the experience can be likened to that of a group of travelers on a journey.

A Typical Journey

A traveler sets own on the journey towards a general destination to discover something. Along the way he or she is joined by other travelers forming a group. They allocate different roles to each traveler.
As they move along, they become more sure about their destination and decide where exactly they want to go, Along the way they stop at various stations for various purposes like visiting friends, places of interest, buying things and so on. The journey between stations are of different distances and take different times. They may take a break at the station or press on when the purpose of their stay is achieved. At each station, they then decide what mode of transport to use for the next part of the journey depending on the terrain or the availability (walk, take a taxi, bus, train or ferry) based on maps, time-tables and travel guides. They may decide to take a different route from the usual trail.
Between stations they may cross state or territorial boundaries.
At some point one or more members may leave the group. and new ones join in. They keep a log of their experience. They may at the end reach their destination or somewhere near it. They may decide to stop there but may feel that they must wander on.

The Clinician’s Journey

Similarly, the steps made by a clinician in caring for a patient may be considered as a journey.
A clinician is unlikely to look after only one patient. On any day, he/she will attend to number of patients with different problems. It is beneficial to picture the journey of a clinician in caring for a particular patient in a specific service delivery setting. His or her journey is towards an optimum outcome and he or she often travels in a group.
The path taken by a clinician working in a hospital is different from one working only in an outpatient setting. A hospital doctor may look after patients at inpatient wards, the ICU and the emergency unit besides the clinic. His daily experience is different from that of a doctor working only at an outpatient clinic, Nurses, on the other hand, mostly (with some exceptions) work at fixed nursing stations.

As an example, the role of SOP/Care plans can be understood, by following the journey of a doctor and the nurse accompanying him/her in an outpatient setting. In the traditional paper based system, the patients would have been registered for the visit, their medical records traced or created and each one is given a queue number. If a Clinical information system is used, a patient list and their queue numbers are created.

The nurse will make a preliminary assessment of the patient . He/she will establish the reason for visit.
On arrival at the clinic, the doctor will call for a patient in turn, The first thing he/she wants to know is the stage of the workflow that the patient is at i.e. what has been done before and what he/she is supposed to do next. He/she is guided by the reason for the visit. If it is a follow up case, he reads the previous notes in the medical record and see whether a plan has been suggested,
If the patient is a new case, the doctor identifies the main complaints and gathers data pertaining to them. He will arrive at a provisional diagnosis and plan more data gathering tasks including investigations. He may start immediate treatment if necessary. Because he/she has to wait for the results of the investigations and the progress of the disease, he/she ends the consultation and plans for another visit at another date.

At the subsequent visit, he/she will review the results of the investigation and hopefully will be able to make a more definite diagnosis. He/she will then plot a more definite care plan. The plan may call for multiple visits to be arranged to optimize care, stabilize the patient’s condition and maintain the care until final resolution is achieved.

During a clinic session the doctor sees patients in his/her care by turn. For each patient he or she performs tasks required for the type of illness and the stage of the care process. Tasks may include the performance of clinical procedures. He/she documents what has been done and the findings in the medical record and plan what is to be done at the following visit.
Patients will make any number of visits required to resolve their problems. The same doctor or another doctor performing the same function will attend to them.

The clinician’s journey at an inpatient setting is similar except that the visit is for a longer duration. Instead of calling for the patient in turn, the doctor moves from bed to bed (popularly termed as ‘making a round’. Between his/her consultations, the patient remains in hospital to be attended by other care givers or to rest. If the doctor considers that care can or is better be given at an ambulatory setting (outpatient or daycare) he will discharge the patient and plan for care to be given at that setting.
The scenario described is one of the many scenarios that typifies a clinician’s journey.

The Patient’s Journey

For the most part, the patient’s journey mirrors that followed by care providers. The patient begins his/her journey by deciding to obtain services at a healthcare facility. Once registered as a patient, the choices he or she can make are restricted. Even though the mode of care is discussed with him or her and alternatives are offered, the alternatives are those that the care provider is willing or able to dispense. Otherwise she is likely to be asked to seek services elsewhere. From then on, the patient is obliged to comply with advice and instructions. The patient is of course at liberty to opt out. The journey can be arduous requiring physical, mental, psychological and spiritual resilience. Issues pertaining to access due to physical difficulties and affordability can arise. The destination may or may not be reached.

Structure and Organization of the Business Model

As in other service industries, to be effective patient care must be delivered for a defined purpose, at explicit times and locations i.e. as a service package made up of scheduled units of services. The entire package offered to a patient is is called the Care episode.

Care Episodes

From a business standpoint, a care episode is the entire service offered for an episode of a particular illness, disease, or health problem. While the entire Reference SOP/Care plan for a disease (disease episode) can be designed as a contiguous whole, the same cannot be done for an Actual plan. Even though the content is the same, the actual care episode is made up of sessions that occur at definite time and place. It begins with the first session and ends when sessions are no longer required or voluntarily stopped by the patient. For acute illnesses, the care episode ends when the disease is resolved. For a chronic disease it is meant to be for a lifetime. Services are broken into feasible packages and delivered at facilities that have resources that match the requirements for delivering them.
The care episode distinguishes the service products offered to the patient. An episode remains active unless care has been discontinued. Typically, each episode is managed by a different team at a different visit. However, if more than one disease affects a patient concurrently during a visit, each may be cared for by the same or a different team. Care is then delivered based on a SOP/Care Plans of each individual illness which have to be combined such that care is integrated and seamless.
Differentiating care episodes are important for purposes of:

  • assignment of responsibilities to specialty teams, units or departments
  • allocation of funding, charges and remuneration
Care Episodes Example

In the example shown in the chart above, this male patient currently 15 years old, had Cleft Lip and Plate at birth for which he had been treated and the episode is considered resolved. He has two concurrent active episodes i.e. Bronchial Asthma and Acute Lymphoblastic Leukemia. He/she experienced Bronchial Asthma from the age of 5 years. He is receiving long term care which is successful in controlling the disease such that acute attacks had become infrequent. He is afflicted with Acute Lymphoblastic Leukemia when 10 years old. The disease successfully underwent remissions twice after treatment. Unfortunately, he is currently experiencing a recurrence of the illness for which he is being treated.

SESSIONS

The Reference SOP/Care Plan presents to the care provider on the theoretical content and sequence of care as consisting of phases, In a business model, activities need to be performed at designated time slots, locations and assigned to identified workers. The designation ‘session’ is used in this context as a generic term to mean all instances of service delivery within a care episode. While in the Reference SOP/Care Plan the phases of care is divided into segments, in the Actual SOP/Care Plan each phase need to be operationalized into sessions with intervals in between.

  • Care Episode
    • Sessions

Sessions allow work to be scheduled because they have the following characteristics i.e.:

  1. defined purpose (why)
  2. defined content (what)
  3. performed at an allocated time (when)
  4. has an anticipated duration (for how long)
  5. performed at a known location, facility or setting equipped with appropriate resources and a conducive environment (where)
  6. organized in a suitable way (how)
  7. assigned to a specific person or team/department/unit (by whom)

Most of these characteristics are absent in the concept of phases.

Further Division of Sessions

Organizing the care episode into definite sessions enables services to be scheduled i.e. partitioned into blocks of time, locations and services.

Schedules and Queues

Services must be provided in an orderly and predictable manner. These requisites are achieved by allocating sessions according to time, duration, place and person through scheduling. Services can be assigned then to time slots and enable the creation of work lists for various care providers. Patients are assured of access to care by giving them appointments. Sessions are scheduled. Turns to receive service items are allotted using a queue system. These ae done at every level of the hierarchy of sessions.
Converting phases into sessions assures the patient that he/she will receive care in a predictable manner. However, healthcare is not as predictable as in industrial services. The time taken to complete various sessions are not very certain because it depends on many variables. The progress of the workflow for a particular patient varies depending on how his/her disease, illness or health problem behaves. The start and end time (turn) of a session depend on the duration taken for:

  • the patient’s previous session,
  • the session of the the previous patient.

Hence, times and periods allocated to sessions cannot be fixed but simply estimated. Being too strict may push the care provider to rush through tasks. Being too lax will lead to time wastage. This uncertainty is mitigated somewhat by the use of queue systems.

VISITS

The care episode is divided into a hierarchy of sessions made up of all instances when a patient seek services from a healthcare facility.

From the perspective of the SOP/Care Plans, even though plans are made on the basis of phases, their actual implementation happens at sessions where there is interaction between the patient and the service delivery facility.

First of all, the care episode is broken down into service-delivery sessions called visits with intervals in between. The visit itself is divided further into smaller time periods and service packages. The top most level of the hierarchy is as shown below:

  • Care episode
    • Sessions
      • Visit 1
      • Visit 2
      • Visit n
      • Last visit
  • Care episode 2

Definition of a Visit

A visit is an instance when the patient comes to the health care facility to receive care. In most instances he/she has to be physically present. The visit is a session that occurs at a specified location and is bounded by time. It contains a set of services. It is formalized by the process of registration and ends with that of discharge. However, the term visit is also applied to instances when the patient is visited by the care provider (as in home care) and also when the interaction is virtual rather than physical e.g. in teleconsultation.

Purpose of Visits

Visits are the sessions during which the care providers executes the activities of the phases of care delineated in the reference SOP/Care plans. The care provider has to decide in the actual OP/Care plan when a visit should happen and where, . A visit is necessary for one of these purposes:

  1. Enrolling and providing services to a new case
  2. Continuation of care of a follow up case

At the beginning of a visit the care provider has to determine the purpose or reason for the visit. The care provider needs to decide the necessity of a visit and its timing. He is then faced with the question of what to do for the visit.
This depends very much on whether the visit is the initial visit or a follow up visit. The foremost purpose of the first visit is to gather information for the purposes of making the diagnosis. The actions to be taken for subsequent phases of care are performed if the opportunity is available at that visit. Otherwise, those are pursued at future visits.

The activities to be performed at a follow up visit is significantly different from that for the initial visit of a new case because, in the former, information about the patient is already available from the previous visit. The diagnosis may have been worked out and a plan has been initiated, In this way, at the beginning of a follow up visit, the attending care provider knows the purpose of the visit and the tasks to be done. However, he/she may have to modify it based on any new information.

The sequence and content of visits do not coincide necessarily with the anticipated change-over of one phase to the next. For each case type or sub-type, what can be accomplished during a visit is variable depending on many factors.
The number of visits required to complete a phase are anticipated through experience or derived from lessons learnt from historical data. There are diseases, illnesses and health problems for which the number and frequency of visits can be fixed as part of the Reference SOP/Care plan. However, in most cases these decisions have to be made at the discretion of the care provider in the Actual SOP/Care plan as care progresses.

The extent of each phase, is a variable period. It can span a duration of mere minutes or can span across many encounters and visits. Case managers or the primary provider set the frequency of 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 financial package.

Initial Visit of a New Case

Patients may make visits in two ways:

  • Planned by prior appointment (scheduled)
  • Unplanned (walk in)

The visit formally begins when the patient is registered. For a new case he has to be enrolled first as a client and then registered as a patient for the visit. A follow up case need only to be registered for the visit.

At the end of a visit, the care plan for the next visit must be made ready by thinking it out and documenting it in the follow up plan.

Planned Initial Visit of a New Case

A planned visit for a new case merely means that the patient has made prior arrangement with the facility. For non-urgent patients (elective cases), visits are scheduled by creating appointment slots in time-tables of appointment books or a computerized scheduling application. On arrival, patients are given queue numbers and served in turn.

Planning an Initial Visit for a New Case

The first visit of a new case is arranged through an appointment. The scheduling system can be used to:

  • allocate a time slot,
  • determine an appropriate service location (facility, specialty department or unit),
  • assign the case to a care provider.

On the patient’s arrival some information may be available from a referral letter, email, phone call or message from the previous care provider. The patient may volunteer his/her reason for visit. Based on the information available a rough plan can be initiated. Proper plans can be conceived only after some clinical data has been gathered and a preliminary diagnosis is made.

Unplanned Visits by New Cases

Unplanned new cases are those where no prior arrangement is made. They are also called walk in cases. New cases with urgent problems can seek services at emergency units without prior appointment. Some facilities e.g. general practitioner clinics may offer services for elective cases to walk in patients.

Planning Visits for Follow up Cases

Follow up cases are those who had prior visit(s) at the facility for the same problem. Follow up visits can also be planned or unplanned.

For the majority of instances, visits are planned and scheduled as a part of the Actual OP/Care Plan at the previous visit. Follow up visits are used mainly for continuity of care and their necessity plus interval are decided mostly at the end of each visit.

Unplanned Follow-up Visits

Follow up cases requiring urgent attention may avail themselves to services as and when they require them (unplanned). Such patients are also come into the category of walk in cases. On arrival, they are listed into groups according to priority, placed on a queue and served according to their turns.

Frequency and Intervals of Follow up Visits

The interval between one visit or encounter to the next is dependent on two factors:

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

There are situations where the transition in the flow of the care 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.

Legal and Operational Importance of Visits

There are legal implications applicable to both the patient as well as the care provider when a patient seeks care or is given care. It is assumed that the patient comes willingly and will abide by the rules set by the facility. Hence, for many processes it is assumed that tacit approval from the patient has been received. However for certain procedures, it is necessary for the patient to provide either verbal or written consent. The care provider as an organization and individually is obliged by law to exercise care when providing services. These obligations are often written and displayed as the Patient Charter.

The above reasons make it necessary for patients to be inducted into care through the formalized process of Registration and of Discharge.
It is also a legal requirement for care providers to keep a record of what transpires during the visit as the medical record. A compilation of records of individual visits make up the medical record of the patient. The obligation to exercise care and to record events (planned and unplanned) is applicable to all visits except for self-care where the onus is on the care provider to provide guidance and the patient to follow it.

Composition of the Medical Record

Location of Visits and Differences in Visit Types

Services by necessity must be delivered at specific locations. Each location is a service delivery unit with specific settings i.e. the facility design (layout) and the resources made available. Hence, visits can be divided into types based on location that include:

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

Each visit must be matched with an appropriate setting. Hence during the care episode, a case may be managed at some or all these visit types.

Suitability of the Care Delivery Setting for Various Visits

The type of service delivery setting for each visit must be planned. Only in some instances, the most appropriate service delivery setting for a particular visit can can be predicted and decided in advance in the reference SOP/Care Plan but for many, the decision has to be made when formulating the Actual plan as the care progresses.
The difference in service delivery settings do not significantly change the clinical content of the SOP/Care Plans but affects mainly the administrative processes, workflow and availability of resources. Certain resources available in an inpatient or day care setting may not be available at an outpatient clinic.

The Emergency Setting

The Emergency setting is designed to provide care for cases requiring urgent attention, resuscitation and stabilization. It receives walk in patients and provides services on a 24 hour basis throughout the year. Patients are triaged and categorized based on urgency and severity. The layout, equipment and staffing is designed to cater for the needs of each category.

Patients with minor illness may receive sufficient car care at the Emergency unit to enable them to be discharged with or without follow up visits at regular clinics. However, for most patients, the Emergency visit is prior to further car e at the in-patient setting.

The Ambulatory Setting

When the progress of the disease is slow and the effects of treatment take time to manifest, the case is better managed as an outpatient.

An ambulatory visit is restricted to the maximum of one work day. There is a limit to the number of tasks that can be completed. This means that, blocks of processes have to be planned for each visit in a more discreet manner

For cases managed in the ambulatory setting (outpatient or daycare), the patient goes home and comes again for another visit to the facility. At a follow up visit the patient’s progress is reviewed and the decision to move through the phases is usually made then. Between visits, care providers will have to depend on patients to monitor their own symptoms, signs and physiological or biochemical parameters by performing simple tests.
In between, the patient may avail himself/herself to teleconsultation, be given home care through home visits by care providers or manage on their own (self-care).
Day care is a setting that is a cross between inpatient and outpatient settings. It allows more complex investigation and treatment procedures to be done. The patient can also be observed for a longer period. It is suitable for care taking a duration of more than a few hours but less than a day.

The Inpatient Setting

In visits at an inpatient setting, the patient stays in the facility allowing the care provider to observe and monitor the patient frequently. As such, there is opportunity to review the care plan for the case as often as daily or more frequently and decide on the readiness to advance through the phases. Also, certain resources are available only in the inpatient setting. Hence, it is suitable for the care of either acute illness or the initial care of chronic illness. The inpatient visit allows the care activities to be repeated within the same visit. Patients rests in between activities and provided with lodging, food, beverages plus other necessities.

Differences In The Care Of Acute Vs Chronic Illness

In acute illness the disease progresses at a rapid pace. Hence, tasks are also performed rapidly at short intervals or continuously. This means that the appropriate service delivery setting for acute illness at the immediate phase is either the Emergency Unit or the Inpatient facility including the Intensive Care Unit and the Labour room. Efforts are directed towards symptom relief, resuscitation, stabilization and support (physiological, psychological, social and spiritual).

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. At the earlier phase, the main objective is to determine the diagnosis as accurately and comprehensively as possible.

The care of a patient with chronic illness can be carried out a slower pace. Chronic diseases are suitably managed as outpatients. The exception is at the start of care of certain diseases where a short stay in an inpatient setting is required for the purpose of close monitoring or stabilization. Care of outpatients occurs at visits spaced at intervals. The appropriate interval between visits is determined by:

  1. the expected speed of progress of the illness,
  2. the time when of results of tests will be ready,
  3. how fast the effect of treatment will become apparent.

The interval between visits 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. Involvement of the patient in care of his/her own self at home is essential. For incapacitated patients, those looking after them (relative or friends or hired aids) will take that role. The same is true for parents in the care of their children.

When the diagnosis is certain, definitive treatment is initiated. Even so, often 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 assessing of the benefits of treatment and the 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 outcomes are achieved.
If the success of the plan itself comes into question, there is a need to review the reliability of the diagnosis and the appropriateness in the choice of the plan or the way it is customized .

Content and Duration of Visits

Visits whether planned or unplanned contain activities that are consistent with those present in phases of patient care discussed earlier i.e.:

  • administration,
  • data collection, review and collation,
  • monitoring,
  • formulation and updating the diagnosis,
  • treatment,
  • review and reassessment..

If possible these activities should be completed preferably in one visit. Otherwise it is carried over to the next visit(s).

Processes in the Initial Phase of Care

For simple cases (e.g. removal of a foreign body in the nostril), the entire phases of care may be completed in one visit. For most cases follow up visits would be necessary.

Planning Visits for Follow up Cases

The next occasion for receiving care after the end of a previous one is called a follow up visit. Follow up visits are necessary to complete the remainder of the phases of care. Occasionally, one follow up visit is sufficient but for the majority of cases, multiple visits are necessary. The frequency and regularity of visits are organized based on:

  • the behavior of the disease (its natural history),
  • the type of care to be given, and
  • the predictability of the response to care.

Visits occur at varying intervals at appropriate service delivery settings. These intervals can be planned at the end of each visit. The duration of the interval depends on how the disease, illness or health problem is expected to develop. Unplanned visits may become necessary because of unexpected turn of events and patients should be reminded to do so.

The location of the follow up visit depends on the resources necessary to accomplish its objectives. For example, a patient who is on an outpatient follow-up visit may have to be admitted for inpatient care if certain complications occur.

Criteria for Cessation or Continuation of Visits

Whether services can be terminated or must be continued depends on whether the objectives of the care episode has been achieved. This depends on the desired outcome for the disease, illness or health problem for which the care episode was initiated. This in turn depends on the nature of the disease. Services can be terminated if:

  • cure has been achieved for a curable disease,
  • no further intervention is possible or necessary.
  • the patient decides not to seek further care.

Visits should be continued when:

  1. the disease is chronic is necessitating life-long care,
  2. there is a residual complication (disability, handicap, incapacity) requiring continual care despite the disease itself had been cured,
  3. the disease has undergone a remission but a recurrence may occur.

For the first two types of cases, definite follow up should be arranged so that care is continued at suitable intervals. The care can be continued at the same facility. If it is more convenient, the case can be transferred or referred to another similar facility after arrangements has been made.
For cases in remission, either follow up at longer intervals or given as and when the recurrence occurs. A such the patient need to be educated as to the symptoms of recurrence and the options available for him/her to respond to it. The patient may seek care at the same facility or at the facility convenient to him/her.

Decision on Continuation or Cessation of Care

EVENTS

Having divided the care episode into visits, the next step is to plan what happens during the visit. For this purpose, the visit is further broken down into smaller sessions termed as events.

Definition of Events

Instances when, where and what services are to take place at a visit are termed as ‘events’. Simply put, events are what the care provider does and the patient experiences during a visit. An event (as much as a birthday party constitute an event) is a happening planned in advance but also refers to any unexpected happening that occur. Planned events are sessions within which services are provided. The word transaction may be used instead but it has a more commercial tone.
As noted earlier, it must be emphasized that even as phases do not coincide necessarily with visits, they also do not coincide with events. However, the accomplishment of the objectives of various phases are the drivers of the flow of events. The care provider plans events according to the workflow of the relevant phase of care described in the Reference SOP/Care Plan. Hence, he/she has to be acutely aware which stage of the workflow the patient is currently involved in.

Events are considered completed when the desired outcome is achieved or the result obtained. In complex cases, the set of events belonging to a phase may be completed only after a few visits. In simpler cases, completion of events of more that one phase can be accomplished in one visit.

The use of the term ‘event’ allows for happenings in patient care services to be looked at from the perspective of both the patient as well as the care provider. For care providers, events are sessions for performing work that include:

  • work that has been planned,
  • actions in response to unexpected happenings.

For patients, events are services that are expected to be given or happenings that may or may not occur.

Therefore, the hierarchy by which visits are broken down further is as shown below:

  • Care Episode
    • Sessions
      • Visits 1
        • Event 1
        • Event 2
        • Event 3
        • Event n
      • Visit 2
        • Event 1
        • Event 2
        • Event 3
        • Event n
      • Visit 3

Types of Events at a Visit

An event is an occasion when services are delivered by a care provider, a team of providers working together at the same time or by machines run by workers or automatically.

An event can be

  1. planned or
  2. unplanned.

The events within a visit is dependent on the actions necessary to achieve objectives of the visit which in turn is linked to the phase of care. The decision on events to be carried out at a visit depends first of all on whether they are for new cases or follow up cases.

At a visit, not all types of events will be performed. It is important to review previously available information (externally from referral letters or shared lifetime health records). Internally entries in medical records at previous visits and the medical record summary should be read.
Collection of new clinical data (symptoms and signs) are always carried out at every visit. The status of the previously known problems need to be assessed and new problems that emerges are identified.
The diagnosis is reconsidered at every visit and updated when there is a change.

The performance of tests and retrieval of results may be spread over different visits.
Treatment too may be ordered at one visit, carried out at another visit often at a different setting. The effects of treatment, if not immediately obvious, are appraised at a later visit.
There are instances when a care provider would attend to a case more that once during the visit by repeating an event or adding an extra event. In other instances, when results or responses take time to manifest, the patient goes home and comes again for another visit to the facility.

To conform to these requirements it is necessary that at the end of a visit the care provider has to use his/her discretion to plan what is to be done at the next visit or visits.

Planned Events

The use of SOP/Care plans will enable almost all events of patient care to be planned. During these events one or more tasks may be performed. Each task is done:

  • for a purpose,
  • at a scheduled time,
  • at a facility or setting with suitable equipment or resources and a conducive environment.
  • by an assigned care provider or a team of care providers.

Planned events may take the following form:

  1. face to face interaction between the patient and care providers (encounters),
  2. performance of actions without the necessity of the presence of the patient (non-encounter events, events sans-encounter),
  3. actions performed on specimens taken from the patient.

For each visit, the events that the patient will be involved in are planned. During each event, actions that are to be performed must also be indicated. Unfortunately, not all actions can be planned in advance. There are also activities that are performed in response to unexpected happenings or incidents.

Purpose of Planned Events

Each event has a purpose and desired outcome. The main types of events is outlined below:

  • administration,
  • data collection, review and collation,
  • monitoring,
  • updating the diagnosis,
  • treatment,
  • review and reassessment,
  • response to unplanned event.

Types of Planned Events

Planned events are the discrete activities of patient care carried out by care providers for various purposes. The types of essential events are listed below:

  1. Registration,
  2. Triage,
  3. Clinical information gathering,
  4. Deriving the initial diagnosis,
  5. Planning and Carrying out investigations,
  6. Deriving or definite diagnosis,
  7. Planning care,
  8. Putting the various aspects of the plan into effect,
  9. Carrying out treatment,
  10. Monitoring and Observation,
  11. Review of plan,
  12. Review of outcome,
  13. Continuation or Discontinuation of care,
  14. Discharge

A more detailed discussion of the contents of events (the tasks) will be discussed later.

Unplanned Events

Besides planned events, there are instances when unplanned happenings occur. These include:

  • incidents,
  • side effects,
  • unwanted developments,
  • mistakes.

When these events happen two types of actions must be performed:

  • acknowledgment or notification of the event,
  • response to it.

The event is observed, noted and recorded. If the event has not been observed y a re provider a history is taken from the patient or by-standers. Actions are taken to counteract the effects of the unplanned happening. Both can be considered as one event or separately. Certain events require mandatory notification (incident reports).
Some of these are not necessarily random events but are known to happen and can be anticipated. In the preparation of the Reference SOP/Care plan, actions in response to them are prepared in advance and documented.

Care Provider Involvement in Events

Besides being allocated to time and place, most events must be assigned to care providers. Indeed, there are different types of events in this regard.

Encounters

Many tasks can be performed only during face to face meetings between the patient and the care provider. The term ‘encounter’ is used for such an event. Encounters are the most important events of patient care because crucial actions are taken within them. The actions performed include those that involve:

  • audio-visual interaction,
  • physical examination and observation,
  • performance of tests, procedures or interventions on the patient.

Care providers performing clinical support functions. also perform events and tasks during encounters. Such providers include:

  • Radiologists,
  • Echocardiographers,
  • Endoscopists,
  • Optometrists and
  • Audiologists

Non-Encounter Events

An event need not necessarily mean a face to face encounter with patients, Care providers may perform actions on their own without the presence of patients (events sans encounter). Such actions include:

  • managing information i.e. reading existing data, data entry, data analysis, data interpretation and deriving conclusions,
  • thinking (cognitive) actions: the formulation of diagnosis and selecting or modifying plans,
  • preparatory activities performed before procedures.

Events of information management can be done, at any time during the visit, without the patient being present. Normally, the first action that a provider does at the beginning of a clinical session is to review the existing data regarding the patient, These can be reviewing the case summary, the monitoring chart, results of investigations done previously (pathological or radiological tests) or notes made by other care providers. At the end or in the middle of the session, he/she may formulate and document data regarding the diagnosis, assessments and opinions. He/she may communicate with other care providers directly, by phone or by forwarding referrals or replying to them. In a new case, before attending to the patient, the care provider can read the referral letter and results of tests already performed that came to him/her with the patient or submitted by other means.
Preparatory activities, like the admixture of medication and setting up of equipment or instruments before procedures, are also done without the patient being present. It also include communication between team members.

All these activities take the care provider’s time and effort. These are events and must be considered when organizing patient care activities.

Tests on Samples

Tests are events that are often performed on the patient (e.g. taking images, EKGs, EEGs, Audiometry, Optometry etc.) during encounters. However, there are tests performed on samples from the patient rather than the patient him/herself. A big advantage is that such events can happen concurrently and at different locations.

In healthcare, very often results or outcome of an activity is not immediately available. Hence, for some activities, intervals during which there is inactivity and waiting are necessary before moving on to the next activity. The duration of these intervals depends on the intensity of care, the more intense the shorter the interval. Intervals between visits are managed using the appointment book or a scheduling application software. Intervals between encounters or tasks are managed using a queue system.

Therefore, the events (encounter, non encounter and tests) can be considered as consisting of sets or blocks of tasks to be performed.

Sequencing and Spacing of Events:

Planning of events is only possible if the sequence of steps can be anticipated in advance. Otherwise, the care provider has to make judgments on the necessity or priority of certain events. This will come with practice and experience.

At a visit, not all of the events will happen or be performed according to the clinical care process. Review of existing data and collection of new clinical data (symptoms and signs) are always carried out. Review of previous values of parameters used for monitoring and recurrent measurement of them almost always occur at visits. The status of the previously known problems need to be assessed and new problems that emerges are identified. The diagnosis is continually reviewed and based on the possibility of a change, further investigations are planned. The investigations are planned and ordered at a visit but may be carried out at other visits. The performance of tests and retrieval of results may be spread over different visits. The intensity of monitoring is reviewed depending on the patient’s condition. Treatment may be ordered at one visit, carried out at another visit often at a different setting. The effects of treatment, if not immediately obvious, may be appraised at a later visit.
To conform to these requirements it is necessary that at the end of a visit the care provider has to use his/her discretion to plan what is to be done at the next visit or visits.

Sequential vs Simultaneous/Concurrent Events

Events, depending on their types, can occur sequentially or can be carried out concurrently. Two care providers may perform different events at the same time even when the patient has be to be present. For example a doctor, may examine the patient while the nurse observes him/her. In joint-sessions, encounters with different care providers happens simultaneously. While they are working in tandem, each may be looking at different aspects and may want to arrive at their own findings and conclusions which may be documented separately. Otherwise a joint statement may be recorded by the leader of the team.
A surgical operation is a joint-session where the surgeon, anesthetist, and nurse conducts different events.

Encounters and non-encounter events can always happen concurrently. Laboratory tests on samples can be performed at the same time or a slightly different time as other events.

Duration of Events

The duration of events cannot be predicted with certainty. For this reason the duration of visits is also uncertain. This is because:

  • events are made up of activities that take a variable time to complete
  • results takes a variable time to be made available
  • resources for certain activities (tests, procedures) are limited and shared such that access to them have to be scheduled.

Setting for Events

Just like the visit, events also will occur at special locations, time and assigned to particular persons to carry them out. Resources (room, machine or person) are finite and often scarce. Events can take place only if the room, machine or car provider is free. Therefore, even if the patient is present at a visit, the event has to be scheduled or sequenced in queue. Knowing the type of events that will happen allows the care provider to schedule the event in advance (i.e. where the visit take place) to schedule the event.

For a visit, patients are assigned to a service delivery unit. Each unit will have specific settings i.e. the facility design (layout) and the resources made available to enable various events to be carried out. Outpatient clinics, daycare units, inpatient wards and intensive care units will have different layouts and facilities. A typical outpatient clinic layout is depicted below:

Typical Outpatient Clinic Layout

Each room or station is designed to enable one or more events to happen or be carried out.

Differences in Content of Visits Depending on Case Type

The decision on how events are to be organized and carried out depends first of all on whether they are for new cases or follow up cases.

Events for a the Initial Visit of a New Case

For a new case, events at the initial visit(s) consist of those belonging to the first phase of care i.e.

  • gathering data for the purpose of making a diagnosis,
  • discovering the patient profile, and
  • instituting immediate care if required.

Depending on the duration of the visit, these events may be completed at the very first visit alone or may take more than one visit to complete.

Sequence and Continuity at Inpatient vs Outpatient Setting

What can be accomplished at the first or initial visit is quite different when it occurs as an inpatient visit versus outpatient visit. The time available in an inpatient setting, makes it possible for more to be accomplished. The care provider is able to complete consecutive encounter and non-encounter events within the same visit.

Events Accomplished at Inpatient vs Outpatient Visit

In an outpatient setting, the time available limits the number of events that can be accomplished. Continuity of care is realized through repeated visits.

Events planned at the Initial Visit(s)

For both the inpatient and outpatient settings, the events planned for the initial visit(s) are quite different from that for the follow-up visits because at the initial visit the diagnosis is usually uncertain, while at follow up visits, the diagnosis is often known. So, events for the initial phase of care is assigned to the initial visit(s). It may not be possible to complete all the events for that phase in one visit. Some events have to be carried over to the next visit.
The next phase of care is initiated at any point (in the same visit or a different visit) depending on whether all objectives of the first phase has been met. At each visit or event, the care provider then makes decisions on whether to:

  • proceed to the next phase of the current plan,
  • change the current plan altogether or in part to another plan.

These events should be completed preferably in one visit. Otherwise, they are carried over to the next visit(s).

Events at a Visit

Events at Follow up Visits

Follow up visits are the means of ensuring the continuity of care. Events for the visit continues according to the workflow described in the Reference SOP/Care Plan. When one phase of care is completed, the care provider moves on to events for the next phase of care.

TASKS

Events are made up of procedures or tasks. The term procedure is used in industries but ‘task’ is used here because it is better understood in healthcare. These tasks can be:

  • technical (with or without the use of machines),
  • cognitive (thinking, interpreting, making decisions),
  • communicational (talking, listening, expressing and understanding body language) or
  • documentation (writing , data entry)

A task is made up of a set of processes. During each event, tasks that are to be performed must be indicated. Unfortunately, not all tasks can be planned in advance. The care provider may depend on the outcome of the previous task to decide on starting the next task.
There are also tasks that are performed in response to unexpected happenings or incidents. Therefore, the hierarchy by which events are broken down further is as shown below:.

  • Care Episode
    • Sessions
      • Visits 1
        • Event 1
          • Tasks 1
          • Tasks 2
          • Tasks n
        • Event 2
          • Tasks 1
          • Tasks 2
          • Tasks n

MAPPING EVENTS AND TASKS TO PHASES OF CARE

The Reference SOP/Care Plan is used to guide the care provider in looking after a patient affected by a particular disease, illness or health problem. The major challenge is in converting the Reference plan into an Actual plan. The Reference SOP/Care plan divides clinical care activities into a series of tasks to coincide with phases of care (described earlier). However, in the Actual plan, activities occur at sessions defined by place, time and persons i.e. visits and events. So even though tasks belong to the relevant phase of care, they do not stand on their own but belongs to events.

Execution of Tasks

Tasks are performed through instructions or orders made in the Actual plan based on those contained in the Reference Plan.

The tasks contained in a phase must be distributed according to sessions i.e. visits and then further according to events within the visit. They must also be grouped according to their type and purpose as task lists assigned to an identified person, the team on duty, or a machine..

The intervals between the visits are determined by the patient’s needs. In this way, a phase may start or end at the beginning of a visit or in the middle of it. However, the application of concept of a phase as a set of processes with a defined objective is still essential in ensuring that care is provided correctly. At a visit the care provider must be aware the phase in the clinical care process that he/she is at.

Organizing Teams and Task Assignment

T

Execution of Tasks and Documentation of Results in a Paper-based System

Tasks are created following instructions and orders.

Execution of Tasks through Orders

In a paper-based system, the plan is written as a set of instructions. They may or may not be grouped into categories as shown below:

Investigation

Hb TWDC
BUSE
CXR

Monitoring

Vital signs 6 hourly
Intake-Output Chart

Nursing

RIB
Nil Orally

Treatment

Tab Paracetamol 1 Gm 6 hourly

In a computerized system orders can be selected from reference lists or tables. For example, orders for laboratory tasks can be classified for that purpose.

Selecting Ordes from Reference Lists or Tables

Task Lists

Organizing Work

Tasks can be assigned to individuals or teams. Responsibility can be assigned on an individual or the member of a professional team. In the second instance the person responsible is the one on duty. Rosters and worklists (task list) are used to assign tasks or jobs.

Task Assignment

The Reference SOPs/Care Plans besides listing out the tasks to be done also indicates responsibilities for performing them. In the Actual OP/Care Plan, they need to be grouped into list of tasks allocated to the care provider or provider team responsible for executing them. Indeed, the effectiveness of care is dependent on each care provider knowing what is to be done for a particular visit or event.
The set of tasks to be performed can be assigned by he team leader. If a computerized Clinical Information system application is used orders can be coded and sent automatically to the unit, work bench or machine assigned to perform it.

Many tasks are performed using machines. In a paper-based system, the work list are created for the operator of these machines who will initiate the tasks manually. The results are read off the machine or printed out. The operator is also responsible to record and disseminate them. results.

Tasks List for Managers

Orders are made for all patients in a unit or service can be-regrouped according to the person or team responsible for carrying them out. This is useful for clinical managers to assign work and for care providers to know their responsibilities regarding all patients under his/her care.

Task List Concerning a Single Patient

Orders of various types for a particular patient can also be grouped. Care providers go through the list and complete them.

Execution of Tasks and Documentation of Results in a Computerized System – Care Sets and Order Sets

Tasks are performed at events occurring during a visit. It is better understood if those block of events are called care-sets. Other terms used are care bundles or packages. These group or sets of tasks to be performed specifically at each event are initiated through orders. Care sets, in turn, consists of groups of orders commonly called order sets. Orders are converted into tasks before their execution. Hence, Order sets become task lists. This is the basis for enabling the execution of the SOP/Care Plans.

In a computerized Clinical information System, how and when the Actual plan is generated depends on whether the patient is a new case or a follow up case. For both categories of cases, the Clinical Provider Order Entry System (CPOE) or otherwise named Order Entry Result Reporting System (OERRS) is used for the purpose. The system must have the capability to group orders into both care sets and order sets. Care sets consists of events and order sets are detail lists of the tasks for each event.

The Order Entry – Result Reporting Function in a Computerized System

When machines are used task list can be created for the machines. The interaction between the machine’s computer and the system handling it requires an interface application. In the case of laboratory tests using samples, the container can be identified as belonging to a patient using bar-code labels. The machine knows what test to do by scanning the labels. This allows for automation of tasks.

Automated Biochemistry Analyzer

For machines performing tests on patients orders can also be submitted to the machines and work lists are created. The patient is identified by scanning bar-codes on their wrist tags. The machine operator controls the machine manually.

Tasks Contained in Events

An event contains fairly specific sets of tasks. Since the clinical care processes are iterative in nature, it is to be expected that similar events and tasks (with some variation) will be repeated at each visit and some will be omitted. While the SOP/Care Plan is used as a guide, performance of tasks must take into consideration the progress of care and the disease.

Decisions need to be made when to move from one phase to the next. Therefore, it is necessary that at the end of a visit the care provider must know what has been done at the visit and what is pending. He/she has to use his/her discretion to plan what is to be done at the next visit or visits. the need to do further tasks to obtain data to clarify an issue,

The relationship between phases, visits, and events is as depicted below:

Application of Policies

Policies that govern, constrain or limit the way tasks are performed are written in the Reference SOP/Care Plan and must be followed in the Actual OP/Care Plan albeit with deference to the peculiar conditions faced.

Continuity of the Workflow

The continuity of the planned workflow must be maintained as the care advances from one phase to the next. A phase is completed when:

  • all events and tasks within them has been done,
  • the outcome or results of tasks are are available,
  • those outcome or results show that the objectives of the the phase are met.

However, the care provider must also consider:

  • the need to perform further tasks to obtain data to clarify an issue,
  • the need to solve an emergent problem, unexpected happenings or incidents.

Sequential vs Simultaneous Tasks

Whether tasks are performed sequentially or simultaneously need to be addressed in SOP/Care Plans. Tasks need to be sequential if it requires:

  1. active involvement of the patient
  2. the use of the result of another task.

The involvement of clinicians are often through direct interaction with the patient. When the tasks requires the patient to cooperate by physical or verbal means, care providers have to take turns to perform them. This is because a patient can only be at one place or interact with one care provider at one time. Only when the patient is free another clinician may use the opportunity to have direct contact whether to gather information or provide direct care. For example, after the doctor has done his /her round, nurses do their own to observe, monitor and chart various parameters .
There are exceptions to this rule like when active input from the patient is not required, tasks can be done simultaneously by different care providers. For example, a nurse may observe the patient while the doctor is talking with or examining him/her. 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. Often, when the patient is unconscious (comatose or under anesthesia) different interventions are done on him/her.

Tasks that does not require the presence of the patient can be done simultaneously or concurrently. Hence, tasks such as making a diagnosis and planning can be done while another care provider is attending to the patient. These are thinking tasks that uses data from memory or from records. Sometimes, the ability to perform it requires the presence of the medical record. In computerized systems data can be presented as views or displays.

  • Radiologists,
  • Echocardiographers,
  • Endoscopists,
  • Optometrists and
  • Audiologists

Pathologists and microbiologists usually work on specimens obtained from the patient and therefore their tasks can be performed concurrently in parallel with that of clinicians.

Repetition and Iteration

In the manufacturing industry, tasks are usually done only once. Repetition is called rework and seen as a failure. The same is true for most clinical tasks. The dictum “do it right the first time and every time” is also applicable to clinical patient care
However, cycles of events and tasks are often repeated not because they fail but intentionally. for various reasons. This repetition of cycles of events and tasks is termed as iterations. .

Meaning of Iteration: repetition of a sequence of operations that yields results successively closer to a desired result

Reasons for Iterations

The entire clinical care is planned as a set of activities that undergo a series of iterations that become necessary because of the need to:

  • obtain more data of increasing range and accuracy and complete the data management cycle
  • reach a more certain and comprehensive diagnosis
  • demonstrate the status of progress of the disease and patient’s condition
  • ascertain the effectiveness of treatment

Therefore, care is fashioned in phases within which there are iterations of various events and tasks. This is because the objectives of a care episode is achieved through the summation of objectives of the various phases. For each phase, the objectives are rarely achieved by one cycle of processes. In most cases, the objectives can be met only through a series of purposeful repetitions. Only by the achievement of objectives of a phase would care be able to move on from that phase to the next culminating in the final outcome.

Iteration as Means to Quality Improvement

Iteration of the processes of data gathering, collation, analysis, and interpretation is necessary to make data more accurate, and sufficient. Interview and physical examination is repeated to determine progress of existing symptoms and signs or the emergence of new ones. Investigations are redone if there are problems with the sample or the test itself. They are repeated to see trends in the results.
Because data acts as input for the formulation of diagnosis, the increasing amount and quality of data obtained from each cycle will facilitate the derivation of increasingly more accurate and comprehensive diagnosis as care progresses. Monitoring and review are necessarily iterative events and tasks.
The recommended treatment regimen should be provided in the reference SOP/Care Plan. However, often when implementing the actual plan, to achieve the optimal result, therapeutic measures such as medication, irradiation, or physical manipulation must be improved by altering the dose, intensity, technique, or frequency.
While surgical procedures that causes permanent change cannot be repeated others that result in temporary benefits (such as dilatation, debridement) may be repeated. As a rule, treatment as an event undergoes first iteration of the tasks of plan, initiate, review ( iteration), followed by subsequent iterations consisting of modify, plan, implement and review again.

The increasing clarity and validity of data, diagnosis, and plan means that the service is constantly undergoing quality improvement. This feature is quite unique to clinical patient care.

Data as the Primary factor in Driving Iterations

From the above discussion, it can be seen that an important reason why iteration is necessary is the need for increasing quantity and quality of information. In that respect, iteration can be seen as the repetition of the data management cycle as shown below:

The Data Management Process Cycle

Data made available after an iteration of a data management cycle becomes an essential input for all clinical events and therefore drives the clinical workflow.

Iteration of Events of Clinical Care

Iteration at Different Service Delivery Settings

To receive care, a patient may attend combinations of inpatient and outpatient visits. The time available in each visit determines the ability to repeat various events and tasks.

Iteration within Inpatient Setting

In an inpatient visit, it is possible to extent the duration of stay such that a succession of both encounter and non-encounter events can happen during the period. Care providers can take advantage of this to perform iterations sufficient to achieve the entire or most of the intended objectives of care. Rather than repeating tasks at different visits, tasks involving direct care are performed at different encounters.

Hence, an inpatient stay allows the care provider to complete nearly all the phases of care. Usually patients are discharged after optimization is achieved such that the maintenance phase is carried on through outpatient follow up visits.

Iteration within Outpatient Setting

If care is started in an outpatient setting, the time available makes it difficult for multiple iterations to occur. Most of the time, only one iteration of various events can occur. Hence, further iterations are planned at repeated follow up visits. The key to the safety, effectiveness and efficiency of care is in spacing of the visits at appropriate intervals. Firstly, the care provider should consider:

  • the development of the disease in accordance to its natural history,
  • the time taken for results of tests are ready, and
  • the speed of response to interventions.

Then, he/she should weigh his/her decisions on:

  • the convenience for the patients, and
  • the capability of the facility.

Facilities Equipment and Environment for Various Tasks

Tasks can be performed at different physical sites (units, rooms) with amenities, equipment and environment suitable for the event. The patient can be moved and be served by the same care provider or the tasks can be accomplished by another appropriate care provider at the same or different site. Facilities and equipment of healthcare are usually scarce. Economic factors need to be considered in planning visits and events.

Sequence and Continuity

ensuring the continuity of care. At a visit, the primary care provider must be aware of the type of case, the Reference SOP that has been selected and the phase at which care is currently being given. He /she must device the actual plan and then communicate it to the rest of the team. Various points in the care process can be used as prompts and triggers of when to begin and end particular events.

Tasks for Various Events

In the care of a particular patient, the events planned may consist of any, some or all of the following sets of tasks or care sets.

  1. Registration,
  2. Triage,
  3. Information gathering,
  4. Monitoring,
  5. Investigations
  6. Formulation of diagnosis
  7. Selection and modification of a plan
  8. Giving and disseminating instructions
  9. Treatment
  10. Nursing care
  11. Prevention
  12. Rehabilitation
  13. Psycho-social support
  14. Patient Education and Counseling

Events for Case Types: New vs Follow up

There are major differences between the management of: new cases vs follow up cases.

These differences occur mainly at the initial visits and relate to the first phase of care i.e. the Phase of Formulation of Diagnosis and Early Treatment. What can be accomplished at the initial visit depends on whether it is at an inpatient or outpatient setting. The management of follow up cases relate to the subsequent phases of care and often cyclical or iterative in nature.

Tasks for a New Case

New cases can be of two types based on whether they have prior care i.e.

  • a fresh new case
  • a referred case

There are differences in the approach between the two.

Tasks for a Fresh New Case

A fresh new case is a patient who has no significant prior care from a care provider. A referred case will have some prior consultation with a care provider where some part of the care process would have been done (i.e. person previously cared for elsewhere). Some clinical information may have been gathered such that the reason for visit may be clearer. As such the difference in the events in the two categories is their purpose i.e.:

Case TypePurpose
Fresh New Caseto provide care for a new health care problem (symptom, symptom complex, syndrome)
Referral caseto continue the care provided earlier at another unit/institution
Care of Fresh vs Referral case

Registration of a New case

Registration is an administrative event. It formalizes the care into concrete sessions essential from the business and legal aspects of care.

Enrollment as a Client

The first step is to enroll the patient as a client of the facility. The tasks involved are:

  • Capture identification and demographic data
  • Create a new entity with a unique identification number in the database of patients i.e. “Patient Register” or the “Master Patient Index” (PMI)

In a paper-based system a register book is used. In a computerized system a Patient Management Application is used. the Client ID number is given to the patient.

If the patient has been previously enrolled, this step is no longer necessary.

Registration for the Visit

The next step is to register the client for the visit. This . The tasks include:

  • converts the client of the facility into a patient
  • create a visit session for which a visit identity number is provided

The first visit marks the beginning of a care episode which will become a distinct service entity once the reason for visit is known. The patient then becomes a case i.e. a patient with a known disease, illness or health problem for which he/she is receiving care.
The visit registration and the subsequent discharge from it marks a session for which:

  • a Medical record file is created,
  • an instance of service for which charges will incur is identified.

Medical records must be documented for any care given. For this reason the visit registration must be made. Charges must be for services given for known transactions given during or for a defined period. The visit unique ID can also act as a Financial number for purposes of charging and billing.

Details regarding registration is given in another article.

The Triage of a New Case

Triage is the procedure of determining priority of care and distribution of cases. It is usually used in managing mass casualties and emergency situations. As a concept, it can be applied at the beginning of care for all situations including for elective cases. It is most useful for the first visit but can also be applied to follow up cases. Hence, the triage procedure will help in:

  1. directing patients to appropriate care,
  2. speeding up the flow of the care process,
  3. selecting the appropriate SOP/Care Plan.

Depending of the way the healthcare facility provides services, determination priority of care and distribution of cases can be done at:

  • the reception counter itself
  • a triage station
  • at the clinic reception

In the case of emergency cases triage is done before or at the same time as registration. For outpatient cases triage is effective when done just after the patient has been registered. It should preferably be performed by a care provider with clinical experience. The triage procedure should follow a standard method. The purpose of triage is the identification of a probable diagnosis which at this point can take the form of a symptom complex, a syndrome or a specific illness (in the case when the patient is a referred case from some other care facility where the diagnosis has already been worked out).
The diagnosis in turn will point to the most appropriate subsequent SOP/Care Plan.

In a walk in elective case, the receptionist or clerks are unlikely to be able to triage patients effectively. However, a person with clinical knowledge or experience can be employed at the reception counter to perform triage based on symptoms volunteered by the patient or written in the referral letter. Otherwise, a formal triage station handled by a clinical care provider should be set up. This is because depending on the level of care (primary secondary, tertiary), clinical services are organized as units based on disease types and area of expertise (general purpose, specialties and super specialties).
On arrival at a clinic reception, further triage may occur.

Data Gathering for a New Case

Data gathering, as an event, occurs at various stages of patient care. This is because data are important input and output of clinical care processes.

Incorporation of Data from External Sources

A referred case or any case that has been cared for at another care facility often arrives with a referral letter and results of some previous tests or interventions. Sometimes the referring facility may send in information through the post, fax or e-mail. If the patient is registered with a shared centralized clinical database (e.g. Lifetime health records) is available, then excerpts from these or URL links to them can be looked for. Data from external sources are useful at the triage event and at the data gathering event.

In a paper-based system the documents brought by the patient or sent in by post, fax or e-mail can be appended to the medical record. In a computerized system the documents can be scanned and the images placed in folder named as externally acquired data or data from elsewhere.

  1. Registration
  2. Triage
  3. Clinical information gathering
    • Interview
    • Physical Examination
  4. Deriving the initial diagnosis
    • collating the information
    • postulating a diagnosis
  5. Planning and Carrying out investigations
    • Ordering
    • Performing
  6. Deriving or definite diagnosis
    • collating the information
    • postulating a diagnosis
  7. Planning care
    • Selecting a Reference care plan
    • Creating an actual plan
  8. Putting the plan into practice
    • Carrying out treatment
  9. Monitoring and Observation
  10. Review of plan
    • collating the information
    • assessing progress
    • continue or change or discontinue plan

Each event has its own set of tasks but a task may not appear in more than one event in a care set at that particular point of care. It is important that tasks are not duplicated within a specific time frame. In a computerized system duplication can be resolved automatically. In a paper based system persons ordering tasks or performing them must be alert to the possibility of duplication.
Repetitions becomes necessary for purposes of monitoring and repeated treatment. These tasks have frequency attached to them. For example, to take the B.P and Pulse every 15 minutes. Indeed machines can be made to perform tasks continuously e.g. to measure oxygen saturation or display the EKG..

Tasks for various events are planned as lists in the Reference SOP/Care Plan but any task, if necessary, can be removed or an additional task may be added to the order set of the Actual SOP/Care Plan. The tasks for various events are elaborated below.

Tasks for a new phase may be initiated at anytime during a visit and event. It may be necessary to leave some tasks to be done at the next visit or next event when circumstances warrants it.

  • Care Episode
    • Sessions
    • Visits
      • Events
        1. Encounters
          • Interventional
          • Non-interventional
        2. Tasks performed on samples
        3. Tasks sans-encounters
          • documentation,
          • data analysis and interpretation,
          • decision making,
          • planning,
          • communications

Selection of the Reference plan and Converting it to an Actual plan

Data Gathering for a New Case

Initial Data Gathering (Clerking, Assessment)

At the initial visit of a new case both the doctor and nurse perform data gathering.
For the doctor, the purpose is to:

  • formulate a working diagnosis,
  • establish the patient profile.

In a fresh new case, for the purpose knowing where to start the doctor is guided by the reason for visit. He/she performs an initial interview and cursory examination and jots them down on a piece of paper or just keep it in memory.

This step may or may not be formalized and documented. The jottings need not be in full sentences but take the form of words and phrases. However, the outcome of it i.e. either the chief complaints or the symptom complex diagnosis must be recorded because it will become the prompt or trigger for the doctor to select the data gathering plan.

Indeed, the tentative interview and cursory examination may be omitted if the initial diagnosis for some reason is known. Instead the care provider can select a data gathering form for a symptom complex, a clinical syndrome or a specific disease straight away.

The doctor starts the formalized data gathering event by selecting a SOP/Care Plan for the chief complaint or symptom complex. The plan will have the appropriate data gathering form embedded in it. This form is usually called the clerking form or history taking-examination form In a paper-based system the doctor will have to find it from a selection of forms available. In a computerized system, the form will be presented automatically based on the tentative working diagnosis.

Repetition and Iteration

Cycle of Tasks

Across visits, the clinical data gathering event itself is a cycle that is continually repeated. The tasks of interview, examination and testing generates data, which are collated, analyzed and interpreted by the doctor to arrive at a diagnosis.

The data collected at the earliest part of the interaction of the clinical care provider and the patient points to the chief complaints or symptom complex diagnosis based on which the gathering of relevant data will be initiated through the use of a specific data gathering form prepared as part of the SOP/Care Plan. The form structure and content will provide guidance to three parts of the data gathering event i.e.

  • interview,
  • physical examination
  • tests using simple point of care tests (POCT)

Each of the events consists of tasks which are initiated by sets of orders.

Based on the data collected, the doctor may arrive at a provisional diagnosis which can be disease belonging to DRG or even a specific disease. he/she will use as the working diagnosis. A specific data collection form will be used for it. Further data collection is done in the guise of:

  • investigations,
  • observations,
  • monitoring,
  • review of symptoms and signs.

Gathering Data through Investigations

Investigations provide data that is objective i.e. more accurate and specific. The information gained is used to:

  1. Arrive at a more definite diagnosis
  2. Disclose the patient profile (general aspects of the health of the patient)

Tests that give specific information concerning a changes caused by the the disease are called diagnostic investigations. Usually, diagnosis becomes increasingly more accurate when investigation results clarify the change in morphology (shape, size, depth) and pathophysiology (alteration of function) brought about by the disease. If earlier iterations of the data gathering process indicates that the patient has known pre-morbid conditions then investigations related to them are also ordered. Investigations are also done to establish the baseline values for tests that are going to be repeated as part of monitoring. Results including images can be kept and used to compare with subsequent examinations for purposes of monitoring and reevaluation.

Investigations are executed through order sets predetermined in the SOP/Care Plans for the suspected disease.

Example of Order Sets for a New Case

The investigation event itself consist of several tasks. Part of the event is performed at the clinical setting while the rest is performed at the laboratory. The tasks include:

  • Order investigation (doctor)
  • Collect and label specimen (specimen collector: junior doctor, nurse, phlebotomist)
  • Dispatch specimen (nurse, attendant)
  • Receive specimen (laboratory receptionist)
  • Assign to laboratory bench (laboratory receptionist)
  • Perform test and validate results (pathologist, biochemist, microbiologist, hematologist, laboratory technician etc.),
  • Submit result to database when ready (laboratory personnel, automated)

In a computerized system, only the specific test need to be ordered. The corresponding tasks and the task list will be generated automatically. The subject of data gathering via investigations is discussed another article and the Laboratory Information System in a separate article.

Structured vs Unstructured Data

At the earliest part of data gathering the type of data to be gathered is uncertain. As such, it is documented as free flowing text which provide information as unstructured data. As the diagnosis becomes clearer, the relevant data elements to be accumulated also becomes clearer. At this point, it becomes more beneficial to document the data as structured data i.e. as data fields with relevant data values. The data collection form embedded in the SOP/Care plan provides guidance to the doctor on what data to collect. Data elements in the form instructs the care provider to perform the task of obtaining those data. Use of standard terms for the data elements (data fields and data values) will allow for proper storage of data into a database so that data can be extracted and presented as views of combinations of data (information) for different purposes.

The advantage of documenting information as free flowing text is that sentences are easier to understand. Structured data appears fragmented when viewed. However, in a computerized system, structured data can be converted to sentences by a process called concatenation. The subject of data gathering in a computerized system is discussed in another article.

Formulation of Diagnosis of a New case

Arriving at the correct diagnosis is critical to the choice of reference SOP/Care plans. As described earlier, gathering sufficient information to formulate the most definite diagnosis for a case require a few iterative steps. This may seem laborious and tedious but must be undertaken diligently. Data data elements to ascertain a diagnosis and to elaborate on it (the diagnostic criteria) are different for different disease conditions. Appropriate data gathering forms must be devised for the purpose.
The iteration of steps gives rise to the issue of duplication of effort (repeat collection of the same data) but can be overcome in a computerized system by auto-filling subsequent forms with data that has already been collected or known.

Determining the diagnosis is a series of thinking processes. It is mandated as orders disguised as data elements to be documented in the paper-based system and as data fields to be filled with values in a computerized system. The task can be made to be mandatory by ensuring that the diagnosis is made or reviewed and documentation is performed.

At a visit, most patients presents with a single illness but some may be affected by more than one present illness. The main illness can be called the primary present illness. There may other concurrent illnesses (obvious or concealed). These have to listed. Both the primary present illness and the concurrent illness need to have the accuracy level determined as either definite or provisional.
The differential diagnosis is a list of possible alternatives to the primary present illness. Since it is only probable its accuracy level need not be stated. The list is an aid to arriving at the proper diagnosis.
Besides the present illness the patient may already have preexisting illnesses, either chronic illnesses or unresolved previous illness, that may already been previously diagnosed or became obvious during the current visit but may require further clarification. Those that have been properly diagnosed should have an accuracy level of definite but those that need further investigation should be considered as provisional.
Besides the pre-existing illness, the patient may have disabilities, handicaps, defects or lingering impairments from previous illness.

The values for each of the diagnostic data fields must be structured data selected from a drop-down list or searched from an appropriate reference table derived from the list created from a standard list (the ICD10 list of diseases or SNOMED).

Tasks to Determine and Document Diagnosis disguised as Data Fields

The phase of clarifying the diagnosis, ends when a definite diagnosis is identified with some certainty. This depends on the data available from the clinical data gathering, monitoring and review events of the earlier phase. 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.

Selection of a Definite Care Plan

The plan for definitive care is chosen and decided when the definitive diagnosis is made. The determination of a definite diagnosis prompts or triggers the next phase which is the phase of definitive care. It begins with the selection of a reference SOP/Care plan for the specific primary disease. illness or health problem identified.
For care to be holistic, appropriate care plans must also be chosen for the concurrent illness, the preexisting illness and the disabilities. Creating a holistic actual plan is a challenge. Acceding to these needs require the care provider to amalgamate a few plans into one. In a computerized system all the tasks can be composed and then decomposed through rationalization into an integrated actual OP/Care plan for the patient. This step sets the stage for the most important aspect of patientcare i.e. treatment.

Selection of Care Plan

Treatment of a New Case

In a new case, at the initial phase of care or the first visit the objectives of care are focused on:

  • Symptom relief
  • Resuscitation
  • Stabilization
  • Preventive actions

Early treatment is guided by the physical, physiological and psychological state of the patient. These would be compatible with the diagnosis which, in most patients, would be would be a symptom complex or a clinical syndrome, However, if the definite diagnosis is certain the definitive treatment can be instituted right away.

Attention is given to airway, breathing, circulation and neurological function. Distressing symptoms like pain, distressing discomfort, anxiety and harmful behavior must be treated immediately by measures spelt out for them in the SOP/Care plans. Potential harm, like risk of falls, worsening through posture or displacement, suicidal tendency and etc. must be anticipated and preventive measures put in place. Possible catastrophic events are prepared for such that the care team are notified and placed in readiness.

Treatment is also iterative in nature and follows the cycle of:

Assess>Treat>Review

The care plan for this stage of care must be selected and modified for the case and executed via orders. Definitive treatment will have to wait until a definitive diagnosis is formulated unless it is imperative to work on a presumptive diagnosis.

Nursing Care of a New case

On meeting the patient for the first time, the nurse must be aware of his/her contribution through the role:

  • to provide nursing care
  • to carry out tasks as a member of the care team

Just like any other health provider, he/she needs to gather data, determine the needs of the patient with regards the professional job of nursing. These needs are with regards to the patient’s:

  • symptoms in need of relief,
  • factors that impair or improve comfort, and
  • factors that weaken the ability of performing daily living activities.

She must put up a plan (often referred to as the Nursing care plan) to address all these needs (often referred to as the Nursing diagnosis) and execute them, to the best of his/her ability or bring up these issues to the doctor.

As a member of the care team she must be aware of the working diagnosis with regards to the working diagnosis of the patient’s illness and the current care plan put up by the the doctor. She plays her role by ensuring that planned events are carried out by means of:

  • briefing, educating and counseling,
  • ensuring that orders with regards investigations, monitoring, and treatment are carried out through communications and liaison with other care providers.
  • performing certain specific tasks assigned to him/her such as collecting and dispatching specimens, administering medications, transferring the patient and etc.

Observation and Monitoring of a New Case

Observation and monitoring through intermittent or continuous measurements of relevant parameters are essential at any clinical setting. At the outset those parameters are measured and documented to provide a baseline.

It is important to review to determine the degree of correction or amelioration achieved by monitoring:

  • oxygenation,
  • blood pressure,
  • urine output,
  • electrolyte levels,
  • degree of consciousness
  • behavior.

Rehabilitation of a New Case

Just as in nursing the function of a rehabilitation therapist need to be distinguished from the professional title. Much of the function of a therapist is preventive. As such the involvement of a therapist should begin at the onset. Both the prevention of disabilities and amelioration (rehabilitation) of infirmity and disability caused by the disease should be given attention and included as an event at the start of care. Certainly the role of physiotherapists or occupational therapists should be indicated in the SOP/Care plan should be indicted at every phase of care. However rather then considered their responsibility of alone, every care provider has a role to play with regards to prevention and treatment of disabilities. A patient may have a pre-existing disability or may incur a disability as a result of the current illness .
For a patient with a pre-existing disabillity considertion must be made on how best to assist the patient to cope with the illness on top of his/her disability.

For the current illness the rehabilitation event includes the tasks of:

  • determining if a disability has occurred
  • identifying the potential risk of occurrence of disability
  • prevention of occurrence or worsening of disability
  • initiation of treatment of the disability

Counseling, Patient Education and Psycho-social Support of a New case

Because of uncertainties regarding the illness and the treatment, patients would be worried and anxious. They need to be briefed on their current status and reassured. The purpose and mode of treatment should be explained. These issues arise for almost all events and tasks. It is the responsibility of each care provider to incorporate appropriate responses to them in relation to those events and tasks relevant to their function.

Summary of Tasks for the Initial Visit(s) of a New Case

The initial visits are those where events and the corresponding tasks that fulfill the objectives of the phase of determination of diagnosis and immediate care of a new case are carried out. Sometimes in less complex cases this can happen in one visit. Often this may take more than one visit.

Example Where Tasks for the Phase of Determination of Diagnosis Accomplished After More Than One Visit

The events and tasks at the first visit:

Events and Tasks Performed at First Visit

Events and Tasks for Follow up Visits

Follow up visits are all visits made after the first visit. At the end of any visit, a decision can be made for the future plan of action especially for the next visit. This depends very much on the degree of completion of the current phase of care. The Phase of Determining the Diagnosis and of Early Treatment, may or may not be completed at the first visit and may extend into the second visit. The events and tasks for the rest of the phases of care will be completed during follow up visits.

Review of existing data and collection of new clinical data (symptoms and signs) are always carried out. Review of previous values of parameters used for monitoring and recurrent measurement of them almost always occur at visits. The status of the previously known problems need to be assessed and new problems that emerges are identified. The diagnosis is updated and based on it further investigations are planned The performance of tests and retrieval of results may be spread over different visits. Treatment too may be ordered at one visit, carried out at another visit often at a different setting. The effects of treatment


Once the definitive diagnosis is made and the definitive plan is started, the follow up visits becomes a series of events and tasks aimed at review, continuation or modification of the care plan.

Planning Follow up Visits

At the end of a visit, the care provider need to indicate what is to be done at the subsequent visit. Where the case is being cared for by a team of care providers from different service units, the primary care provider is responsible for coordinating the visits. Besides the primary care provider, the other team members can be:

  1. Other clinical specialty units
  2. Allied health professional units including:
    • Physiotherapy
    • Occupational therapy
    • Clinical Psychology or Counseling
    • Social care unit
    • Optometry
    • Audiology
    • Endoscopy, Respiratory and Cardiac diagnostics
    • Specialized care nurses (Wound care, Home-care)
    • Third party services (e.g. for transport)
    • Case managers
    • etc.
  3. Clinical support service units
    • Pathology (Laboratory)
    • Imaging (radiology)
    • Pharmacy
    • Sterile supply and Sterilization

Initially the primary care provider can arrange for visits for his/her part in the care and refer cases to the rest of the care providers who can then plan visits for their services on their own. This is done through scheduling. Hence, a patient may be scheduled for an outpatient follow up or an inpatient admission or readmission. When the care team involves many services, coordination may prove to be a challenge. Use of a computerized system avoids conflicts concerning the timing of appointments through a shared integrated Scheduling system. There is a place for case managers to act as the coordinator.,

Planning Events and Tasks at Follow up Visits

Events or tasks for the next visit can be planned before the discharge from the current visit. This will allow for events for a phase not completed at the current phase to be completed at the next visit. It also allow the the care provider to plan in advance events for the next phase. The practice is for the care provider to give instructions for two categories of tasks:

  • specific tasks to be done during the interval between visits
  • specific tasks to be done at the start (after registration) of the next visit
  • the general plan for the next visit

Indeed between the visits to the In a paper-based system by making appointments, giving instruction and providing request forms to the patient on discharge. Patients bring home these forms and present them to the units concerned at the appointment date.
In a computerized system, orders can be made in advance using the the future orders functionality to be activated on registration of arrival at the relevant unit.

The circumstances that make it suitable for care to advance to the next phase often become evident at the end of a visit or at the start or middle the subsequent visit. At the start of a follow up visit, the care provider has to review what has happened to the patient at the last visit but also during the interval during which his/her current condition has changed. The investigation results not ready during the previous visit and those performed during the interval would become available. If the patient has been asked to observe, measure or record certain monitoring data, these should be reviewed.

Moving forward is only expedient if the objectives of a phase has been achieved. It is possible in uncomplicated cases for all the phases of care to be completed during one visit. However, for most cases the Phase of Initiation of Definitive care, Optimization of care, Maintenance of care and Resolution are carried out at a number of follow up visits.

Registration of a Follow up Case

At follow up since the patient is already enrolled, only the visit registration need to be done. As mentioned earlier, the visit period defines the limits of the medical record and also the charges incurred.

Triage of a Follow-up Case

The concept of triage can also be extended to follow up cases. A follow up visit, at a outpatient or inpatient facility, is the occasion for receiving care following the previous one. There are two main types of follow up visit:

  1. Elective Follow up or Readmission:
    • Purpose: to continue the remainder of care previously planned for a known disease or health problem.
  2. Emergency Follow up or Readmission:
    • Purpose: to provide care in relation to an illness or problem cared for at a previous visit:
      • a complication of illness,
      • complication of treatment,
      • unexpected event (recurrence, exacerbation).

The type of visit and the location is determined and scheduled. If he/she is to be referred to an external facility, arrangements are made and a referral letter is written.

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 altogether (e.g. relinquishing care to another care provider or unit).

However, the decision to execute the plan is made only after the patient has been reviewed to determine his/her status allows its continuation. 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 certain interventions become necessary.

Data Review and Gathering of a Follow-up Case

Two events concerning dat happens at follow up visits i.e.:

  1. review of available data
  2. gathering of new data
Review of Existing Data

At the beginning of a follow up visit, the care provider conducts a review by reading:

  1. the existing data retained in the medical record or the Clinical information system.
  2. the new data made available in the interim period between visits
    • results obtained from investigations carried out,
    • monitoring data recorded by patients on their own

The medical record or the Clinical information system must be available to the care provider at the start of every visit. It is preferable that he/she reads the information before the encounter with the patient. The investigations performed at the previous visit may be only available at the current visit. Investigations may be done during the period between visits. Patient may have recorded observations and monitoring on their own during the interval between visits..

Gathering New Data

The event of data gathering at follow up has two main purposes:

  1. to obtain additional data to clarify the diagnosis and the patient profile,
  2. to obtain data regarding the progress of the disease and the effects of treatment

At a follow up visit interview and clinical examination and simple POCT tests are always carried out. If the definite diagnosis has not been reached previously, fresh additional clinical data (symptoms and signs) when taken with results of investigations available at that point may help clarify it.
The performance of investigations may be spread over different visits, such that those planned and ordered at one may be carried out at subsequent visits. Also, results may only be available at later visits.

Review of Diagnosis of a Follow-up Case

At the start of a follow up session, the care provider must be aware of the current working diagnosis. If a definite diagnosis has not been made he/she must continue with attempts are defining a definite diagnosis through further review of symptoms, signs, monitoring. If necessary further investigations have to be done. He/she may consult or get the opinion of other colleagues or experts.

If the definite diagnosis had been reached at the earlier visit and treatment has been started data is gathered to determine the progress of the disease and the effects of treatment. The status of the previously known problems need to be assessed and new problems that emerges are identified. The diagnosis is updated and based on it investigations, monitoring and treatment for it are planned.

  • Repeated measurements,
  • Entering data into charts of various parameters,
  • Interpretation and analysis of the changes in the data values and prediction of trends (Progress Review),
  • Comparing trends with progress of exiting symptoms and signs, and discovery of new ones (Reassessment)

The objective is to make value judgment (evaluation) on whether there is improvement, deterioration or absence of change based on which an appropriate response is made. This can be immediate or can take the form of decision to continue, modify or change the care plan.

Treatment of a Follow-up Case

Scoring systems. discusseg further in the phase of review and re-evaluation.


To conform to these requirements it is necessary that at
the end of a visit the care provider has to use his/her discretion to plan what is to be done at the next visit or visits.

Treatment is the main part of the actual Operating procedure/Care plan which in turn depends on the diagnosis. Hence, if the definite diagnosis has been made at the first visit then the definite plan would have been started, Treatment at the follow up visit would then be continuation and review of the plan made.
For many cases, however, the definitive diagnosis could not be made at one visit because part of the data gathering process is incomplete or results are pending. Then events and tasks of the first first Phase of care is only completed at the second visit or later. In the interim, treatment is derived from the care plan developed for the working diagnosis which can be a system complex, clinical syndrome or a DRG.
Once the definitive diagnosis is made, the Reference SOP/Care plan selected can be the basis for the definitive plan. Yet, the care provider need to consider all the information regarding the patient and his/her own judgment to realize a more precise and didactic treatment plan for the care team to follow. Members of the team while taking the cue from the primary care provider can also make their own judgments based on their own knowledge of the disease and the patient. However, decisions should be made through constant consultation. It is important therefore that care providers share a common integrated medical record or Clinical information system.

Treatment too may be ordered at one visit, carried out at another visit often at a different setting. The effects of treatment, if not immediately obvious, are appraised at a later visit.
To conform to these requirements it is necessary that at the end of a visit the care provider has to use his/her discretion to plan what is to be done at the next visit or visits.

Example: Phase of Determination of Diagnosis Accomplished at the Second Visit

Continuing from the example used earlier, the events and tasks at the second visit is outlined below:

Events and tasks Performed at Second Visit

Treatment of Symptoms of a Follow-up case

Acute disease may disappear. Immobilization. Increase with increasing mobility. Chronic disease will persist. carry on for recurrent symptoms

New emerging symptoms

Nursing Care of a Follow-up case

Monitoring of a Follow-up Case

At the early phase or initial visit, parameters are measured and documented to provide a baseline value. At each follow up visit monitoring is an essential event consisting of.

  • Repeated measurements of relevant parameters
  • Data entry into charts or tables in paper-based system or forms in computerized systems,

Comparison of values recorded in charts at progressive visits give an idea on the trend. In computerized systems the trend can be displayed in various statistical presentations.

Trends help in:

  • giving a picture of the progress of the disease in comparison to its natural history hence confirming the accuracy of the diagnosis or otherwise
  • clarifying the diagnosis in terms of behavior of the disease so that differentiation can be made regarding sub-type, severity, stage and grading
  • assessing the response to treatment (success or otherwise)

For an outpatient case, monitoring is done as an event made up of various tasks taking the form of single measurement of relevant parameters repeated at each visit. In the case of inpatients, this event will be repeated intermittently at appropriate intervals or continuously for certain periods, throughout the visit depending on needs. Actually, monitoring involves a series technical, data entry and thinking tasks:

select a parameter
> measure and observe repeatedly
> evaluate the trend
> take action
> continue to measure and observe

Relevant Monitoring Parameters

Monitoring goes beyond measurement and charting of vital signs. Many more parameters or experiences can be observed or measured repeatedly as elements to monitor. The measurement or observation tasks can be made by care providers, other persons caring for the patient or the patient him/herself. hence monitoring can be done during the visit or during the intervals between them at home. The parameters include:

  1. Physiologic parameters
  2. Intake-output
  3. Biochemical parameters
  4. Microbiological and Hematological tests
  5. Imaging studies
  6. Reassessment using diagnostic studies such as endoscopy etc.
  7. Symptoms and signs

Monitoring tasks can be extended to intervals between visits as part of self care.

Charting

Monitoring of vital signs, Intake-output and conscious level are usually performed by nurses. These tasks can be ordered and the frequency specified. It goes into the nurses’ task lists. The values obtained are recorded in charts (graphs or tables).
Results of laboratory investigations can also be tabulated. In a paper-based system, results from result slips can be Tran scripted into tables. In a computerized system the results can be presented in a spreadsheet mode and the trend depicted as a graph.

The dates of imaging, and endoscopy studies can be listed in chronological order. In a paper based system, the written results (often called reports) can be put separately arranged in order of date of performance but this is not a good practice because it would separate them from the main body of the medical record. In a computerized system, links can be made from the list of studies performed to their results. The results can also be viewed in the Electronic Medical Record

Some clinical symptoms and signs are important enough to be documented in the medical records as well as in charts. Examples include:

  • uterine contractions
  • fits or seizures
  • palpitations
  • bleeding per vagina

However most symptoms and signs, would be recorded as text entry as part of the event of data gathering. In a paper-based system, the care provider need to peruse trough these entries to compare the values across time.
In a computerized system, if structured data is used, the application can identify occurrences and list or tabulate them in a separate display format.

Self Monitoring by Patients

Patients can be taught to monitor certain symptoms or signs during an inpatient visit or when they are at home. (e.g. fetal movement, mastalgia, start and end of menses) using simple charts. Where measurements (e.g. Blood Pressure) or biochemical tests can be done using POCT instruments (e.g. blood sugar level), patients can be trusted to perform and chart them.

Progress Review and Evaluation of a Follow-up Case

The Progress review of the patient is a cognitive event consisting of four steps:

  1. Interpretation and analysis of the changes in the data values obtained from monitoring and observations,
  2. Re-assessment of clinical manifestations ( symptoms and signs) to compare with initial findings plus possible discovery of new ones,
  3. Comparing values over the care period to determine and predict trends,
  4. Evaluation of outcome of care and effectiveness of the care plan (adherence to plan, achievement of desired outcome)

Progress review and evaluation are the main events of the Phase of optimization of care. Values of various parameters recorded through monitoring and observation are reviewed from time to time (at every visit for outpatients and at certain encounters in inpatients). The patients symptoms and signs are also reassessed. Based on the trend an evaluation is made of the progress of the disease and the effectiveness of the treatment.

The care provider makes an effort to fine tune or modify the care plan in response to the progress of the patient. The patient undergoes the iterative processes of definitive care, review, re-evaluation and followed by modification of the care plan when necessary.

Transition from Stabilization to Maintenance

At a certain point during follow up the care provider has to decide whether the optimal status of the patient stabilization has been achieved and the care is considered optimized. If so, the patient goes on to the Phase of maintenance. Otherwise, modification of treatment plan or the care plan itself is necessary.

However, the decision to execute the plan is made only after the patient has been reviewed to determine his/her status allows its continuation. 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 certain interventions become necessary.

Interim or Intermediate Measures of Outcome

The judgment of whether a patient with a disease is better or worse is a central question in patient care. The SOP/Care plan should provide a guide for the criteria to decide on the:

  • the improvement or deterioration of the disease
  • positive response or otherwise to treatment

Progress can be taken as an interim or intermediate outcome of care. Good progress assures the care provider that he/she is on the right track of achieving the desired or expected final outcome.

Surrogate Indicators and Scoring Systems

Progress can be expressed simply as good, satisfactory, unchanged or poor. However, to be objective, the degree improvement of the patient’s condition can be one or more surrogate indicators or a standardized scoring system. For example for acute bronchial asthma the  peak expiratory flow rate (PEFR) alone can be used as indicator of progress or besides it the respiratory rate, SaO2 and in severe cases PaO2 can be added. For diseases that affect many systems like for example Systemic Lupus Erythematosus (SLE), a more elaborate scoring system consisting of multiple clinical manifestations and laboratory tests would give a more accurate picture of progress. Calculating the score would be arduous if done manually. However, if a computerized system is used, the parameters to be measured can be indicated in the SOP/Care Plan such that the score can be calculated automatically.

Rehabilitation of a Follow-up Case

Should not be an afterthought. Preventive and rehabilitative. Results of the assessment will help determine the patient’s level of dependence on care providers. It also indicate the type of rehabilitative efforts to be undertaken. The degree of a patient’s disability should be assessed. The likely disabilities include:

  • assessment of the ability to perform activities of daily living (ADL) which can be documented as a ADL score.
  • disturbances to the senses pf smell, taste, touch, sight and hearing
  • limitation of movement and physical strength
  • disability of speech
  • disorder of thought processes
  • psychological disturbance

Preventive Care of a Follow-up case

Primary prevention, secondary, tertiary.

Psycho-social support of a Follow-up case

Patient Education and Counseling of a Follow-up case

Continuity of Care

The SOP/Care Plan describes the service given to a case i.e. a patient with a particular disease, illness or health problem, The entire service is termed as a care episode. It is necessary therefore to determine whether the service ends at a particular date or continues indefinitely. At the end of each visit, the doctor in charge must decide whether to continue or discontinue care through a decision-making event. The decision to discontinue depends on whether the objectives of care has been achieved or no other benefit can be gained by continuing the service. It can be decided also by the patient if he/she voluntarily opt to not avail himself/herself to further care.

The circumstances that make it suitable for care to advance to the next phase often become evident during the visit and encounter itself rather than before it. Moving forward is only expedient when the care provider has reviewed what has happened to the patient during the interval, his/her current condition and the investigation/monitoring data that have accumulated .

An important task in this decision-making event is the assessment of outcome and its documentation. The tasks involved is evaluation of the status of the a patient and comparing it with the expected or desired outcome or treatment end-point. The decision to claim success vs failure varies with status at presentation severity, stage, grade, pr-morbid status etc. which in turn determines whether the desired outcome is that of cure, containment, amelioration, or palliation.

Cure

Total eradication, survival, with or without long term complications. total elimination or natural extinction,

Containment

arrest or slowing down of the disease process, prevention of complications, long term short term. repeat assessment. Remission, suppression

Palliation

inability to cure is not a failure. should not deter motivation to care. relief, avoidance of distress, comfort, minimization of symptoms, restoration of function, socio-psychological state, empathy. end of life management. spiritual support. match with patient’s expectations. honesty. Support and Relief of symptoms and of disturbed function

Events and tasks to Realize Continuation of Care

It is essential that the care provider ensure the continuity of care. Scheduling and Appointments. Future plan Plan for the next visit.

Continuity Beyond Optimization of Care

The care can be continued in the same facility by the same team of care providers who initiated the care episode or passed on to care providers at another facility. However, it is best for the patient if the care has been optimized and reached the maintenance phase before they are referred to providers at other facilities.

In general, chronic diseases requires follow up care for an indefinite period if not for life. There are chronic diseases which dissipate over time and may become inactive. On the other hand, many acute illness/health problem may go into temporary remission but may return as recurrence, resurgence or exacerbation. Therefore, their care may not be ceased completely.

There are acute illness/health problem that are the manifestation of complications of an underlying chronic disease (for example, Acute Myocardial Infarct as part of Coronary artery disease). Cessation of care for the acute problem must be continued as care of the underlying disease warranting further observations, monitoring investigations and treatment. The acute illness may also give rise to permanent or semi-permanent disability, deficiency, handicaps or inconvenience. In all these instances, long term care will then be planned and provided.

Plan for Continuation of Care – Maintenance

Discharge Plan at the End of a Visit

If care is to continue at the same facility, opportunities should be sought to reduce follow up attendances by increasing the intervals between visits. Also care can continue at settings more convenient for the patient for example via home care or teleconsultation.

For patients in need of continuation of care, a plan of action must be made for future visits. The type of visit and the location is determined and scheduled.

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 altogether (e.g. relinquishing care to another care provider or unit).

Transfer of Care through Referral or Delegation

The primary provider may delegate the responsibility of care to providers at other facilities for the convenience of the patient. The facility can be:

  • within the same organization
  • belonging to an external organization

In both instances, a formal referral referral (via referral letter or other means) and arrangement is made. The care plan and adequate information (preferably a case summary) should be provided. The primary care doctor, family doctor or school/factory nurse and voluntary bodies are the most appropriate care providers to take on this responsibility. With regards disability or handicaps, therapists, counselors, optometrists, audiologists or social workers may be more appropriate. Indeed for most cases care is not really discontinued but continued by self-care.

For the first situation, the reason for referral is to get other care providers involved in the care based on the requirements of the SOP/Care Plan. For the second situation the team leader (the primary care provider) considers the advice and may or may not modify the SOP/Care Plan accordingly. For the third situation, the responsibility of care is transferred to the team that accepts the case. The team leader would then modify the SOP/Care Plan or choose an entirely new one.

Ensuring Compliance to the OP/Care Plan

Care providers looking after the patient must be aware of both the reference SOP/Care plan and the actual plan that has been developed from it. Since both of them evolves constantly with the status of the patient, the changes made must be continually made known to the care team.

Mechanisms must be put in place to ensure that members of the care team comply with the intended plan. These consist of:

  • declaring the SOP as the standard to be followed
  • ensuring adherence to it
  • measurement of the quality of the intermediate and the final product
  • continual improvement of processes and outcome
  • putting in place remedial measures when necessary

Documentation and Dissemination

Choice of the Reference SOP/Care plan to be referred to. Should be declared when the working diagnosis is made or changed.

Similarly, when the actual plan has been formulated, it is then by

  • documenting it
  • communicated to other care providers
  • check on compliance
  • remedial measures

(presented under the section for Plan) in the medical record/case notes or the Clinical Information System. Amendments also to be recorded.

Documentation and Dissemination
Communication

For continuity of care, a care providers wants to know what transpired during the last visit.

  • the Medical record
  • Visit summary
  • Case summary
  • what has been planned
  • what has been done
  • what to do next

Quality Control – Ensuring Compliance to SOP/Care Plan

Quality control “The regulatory process through which we measure the actual performance, compare it with standards and act on the difference” The information available to them can be in the form of:

Access to Medical Records

Two functions

  • means of communication
  • record of performance

A source of condensed information regarding the patient, during the visit, within the same care episode  and across episodes. The Medical record (paper-based or EMR) is useful as a source of information, about what has transpired in the past for the purpose of ensuring continuity of care. The entire medical record is an aggregation of records of individual visits, each visit being defined by the period between the registration and discharge or check-out.

Visit / Discharge Summary

To know what transpired during the last visit, a care need to look at the last entry in the record. This is easy if the notes are short e.g. as for a entry for a follow up at an outpatient visit. However, if the visit is a long inpatient visit, the notes can be quite long. It is more convenient to read a summary of notes regarding events during every visit. Hence, it is good practice to write a summary which can be an entry embedded in the medical record or a separate document attached to it.

Case Summary

Ongoing vs final
A compilation of visit summaries will make up the summary for the entire care episode. In a computerized system the case summary should be a report derived from the EMR

Discharge Plan after Cessation of Care
Checking Compliance

Therefore at discharge from the care episode, patients must be given adequate education on how they can maintain their health. They should be encouraged to return to the facility or seek the help of any other health care professionals if they are unwell or their health deteriorates.

————————————

Execution of the Actual Plan

The way the Actual plan is implemented depends on whether a traditional paper based system or a computerized system is used. Success depends on familiarity and awareness of care providers regarding both the Reference Plan and the Actual plan. For the Reference plan the care provider the important factor is availability and access. For the Actual plan the key factor is communication and dissemination.

Reminders, Prompts and Triggers

At a visit, the primary care provider must be aware of the type of case, the Reference SOP that has been selected and the phase at which care is currently being given. He /she must device the actual plan and then communicate it to the rest of the team.

Reminders in a Paper-based System

In a paper based system the medical record is the means of recording the actual plan and communicating it. Formulation of the actual plan is an event that must be recorded in the medical record. Because the medical record is chronological, the care provider to has to flip through the pages to find where it is written. This is very tedious. To overcome this, the plan can be rewritten (often in the form of a table) and placed in a designated location elsewhere in the medical record file. This requires transcribing and reformatting it as a separate document. This duplication of effort is the reason why care plans do not work well in paper-based systems.

In a paper-based system the care provider has to figure out manually what to do when the patient shows up at the point of care.

Use of Prompts and Triggers in a Computerized System

In a computerized system, rather than writing the plan directly into the medical record. the planning event is a distinct functionality of the Clinical Information System (CIS). The planning event can be viewed as an item in the menu. The resultant plan is incorporated later into the medical record. In the CIS, various points in the care process can be used as prompts and triggers of when to begin and end particular events. Prompts and triggers are aids in ensuring the continuity of care. Prompts are suggestions made to the care provider on what to do next. Triggers are automated steps which when consented by the care provider will be executed.

The set or block of tasks to be performed at a session can be proposed to the care provider at the start of the session through prompts and triggers. These are dependent on

In a computerized system, the application can automatically prompt the care provider or indeed trigger and automatically present the pertinent part of the application or system required. Events and tasks can be prompted or triggered by:

  1. administrative events (registration, admission, transfer, )
  2. outcome or results (positive vs negative)
  3. change in diagnosis
  4. completion of an event or task

Prompts and Triggers Based on Visit type and Reason for Visit

When a patient is seen at the beginning of a visit, the events that will happen and the tasks that will be performed, i.e. choice of care plans, can be prompted by:

  • visit type (new or follow up)
  • reason for visit
  • result of triage
  • arrival at a point of care
  • completion of a previous event or task
  • visits
    • Schedules, appointments, arrival, discharge
  • events – completed care-set
    • Queues
  • tasks – completed order-set

The visit type (new or follow up) indicates whether a new plan need to be formulated or a plan selected previously is to be continued.

There are major differences between the management of new cases vs follow up cases. These differences occur mainly at the initial visit and relate to the first phase of care i.e. the Phase of Formulation of Diagnosis and Early Treatment.

For a new case the plan is triggered by the reason for visit identified at the time of registration and/or triage.
For a follow up case, instructions can be prepared beforehand at the time of discharge from the previous visit. Since the diagnosis and the stage in the phase of care is known, the tasks to be performed can be listed and assigned right at the start of the visit.

Prompts and Triggers for a New Case

For new cases the choice of the SOP/Care Plan for the early phase of care is selected by the attending care provider; first by the person conducting the triage and subsequently in a cascade by subsequent care providers as the diagnosis is clarified. Grouping tasks to be performed during an event is the basis for enabling the creation of a set of orders called order-sets and subsequently task lists.

The prompts and triggers for various phases, events and tasks will be discussed in detail in appropriate sections below.

Job Allocation

The work of providing services are usually allocated based on expertise such that different care providers or teams of care providers will be responsible to perform sets of tasks as a package.

During the care of the patient, the responsibility of providing care often changes hands. If the diagnosis changes or different problems arise the case can be referred to another care provider or a different clinical team with the appropriate expertise for the purpose of:

  1. co-opting them into the care team
  2. obtaining advice
  3. passing on the responsibility of care to another care provider or team of providers (clinical department or unit)

Cessation / Discontinuation of a Care Episode

If a patient’s illness has undergo resolution through total elimination or natural extinction, he/she is considered cured. Care can be terminated with confidence. On the other hand, patients can have illnesses/health problems that dissipate into remission, undergo recurrence, resurgence or exacerbation. Their care care cannot cease completely.

and what evaluation criteria need to be met to declare it safe for the care to be terminated.

If the illness appears to have resolved, discontinuation may be made abruptly or phased out gradually. The care provider has to decide manner by which care is to cease including how medication or other treatment is to be tapered off

C. DOCUMENTATION OF REFERENCE SOP/Care Plans

%d bloggers like this: