Project Management Solutions
Electronic Records Management
Drug Advertising Paradox
Government agencies or NGO’s that have community interests on the other hand usually provide unbiased information bulletins, primarily in the form of notices and public warnings. They are supposed to inform the public and filter any and all biases regarding the subjected medical product, device or service.
There is a parallel in the use of advertising and receipt of expert advice from third-party professionals, in other industry sectors:
A) Financial Sector
There are multiple reasons why an individual seeking to invest their monies into a financial transaction or income earning mechanism requires the input and advise of financial advisors and securities legal counsel.
B) Legal Sector
There are multiple reasons why the legal/judicial system requires a citizen have a legal representative act as an officer of the courts, to represent the defendant or plaintiff in a trial.
The same logistics and decision making methodologies apply to an individual contemplating or who is in the process of being subjected to a pharmaceutical product, service or clinical trial process; it will impact their personal safety and well-being.
The requirement for third-party intervention and representation is essential when an individual is contemplating or is in the process of being subjected to a product, service or process, be it financial, legal or medical by nature. The common element is that in each discipline, it will impact the personal safety, security and well-being of the participant/recipient. This is due but not limited to the following series of extenuating factors:
- technical procedures
- legal protocols and adherence
- regulatory guidelines and procedures
- emotional and physiological effects
- impact from the entire process.
In essence the participant/recipient’s judgement is blurred, biased, influenced by multiple factors thus distorting their ability to make sound decisions and actions; to allow a citizen to act in the best interests of their person and the community at large.
The financial, legal or medical advisor, also known as the accountant, lawyer or doctor respectively are professional consultants, licenced and operating on a fee for service basis. Their licences provide them with authority to operate within regulated parameters and strict guidelines. They are required to guide and advise their clients (patients) within the defined set of licenced criteria.
Ergo from a medical sector perspective, the general practitioner is being asked and paid to inform their patient and recommend a specific medical device, drug, service or therapy. The underlying focus is the type of information that is being made available both to the practicing, licenced professional and the patient. The present process is bi-directional:
1. There is publicly and readily available information available for a specific medical device, drug, service or therapy that a potential patient can acquire.
2. There is detailed, scientific and technical information provided to the medical professional or doctor for a specific medical device, drug, service or therapy.
Most of the required information is provided by the medical device or drug manufacturer or by a medical regulatory and public safety organization. Currently, the difference is not in the access to and availability of the required technical information both to the patient and the doctor. On the contrary, it is the lack of availability of simple, easy to read and understand, unbiased detailed information regarding a specific medical device, drug, service or therapy in simplified language. The onus therefore still today rests with the medical professional’s ability to:
- Interpret the technical information and data
- Make professional and informed decisions
- Convey the technical information and data to the patient
- Provide the patient with the ability to make their own informed decision
Our existing socio-economic infrastructure is driven by the polarization between opposing forces:
1. Entities and individuals that have a vested and biased interest, in the successful marketing of a specific medical device, drug, service or therapy; they will derive a personal benefit, economic or non-economic remuneration.
2. Entities and individuals that have a community, unbiased interest to serve their citizens in the safe use of a specific medical device, drug, service or therapy
3. Individuals that will personally benefit from their personal and safe use of a specific medical device, drug, service or therapy
Under the current infrastructure, we have to maintain a delicate advertising and promotional balance. This balance has to be measured in terms of:
1.Minimizing the biased advertising impact on the individual to make an informed decision for their personal and safe use of a specific medical device, drug, service or therapy.
2. Minimizing the information controls and promotional restrictions on the entities or individuals that form the supply chain of a specific medical device, drug, service or therapy.
3. Minimizing the regulatory involvement and intervention on information content by entities and individuals that have a community, unbiased interest to serve their citizens.
Medical Research Protocols - The Business Perspective
PROTOCOLS - THE BUSINESS PERSPECTIVE
The product plan is the framework for all implementation plans
The core and essence of any clinical research is a clearly defined project plan - otherwise known as the "protocol". The project plan must clearly outline the short-term, mid-term and long-term goals and objectives, strategies and tracking mechanisms for the clinical trials that can quantitatively and qualitatively measure the progress and performance of the desired clinical testing goals and objectives, for the various clinical trial phases of the project life cycle.
The project plan will compliment the corresponding project implementation plan.
Clinical research projects always face the challenge and task to fulfill the designated clinical testing goals and objectives on time and within budget. It is therefore paramount that the project plan clearly identifies and defines the clinital trial parameters, research conditions, set criteria as well as FDA compliance and limitations; they have to be budgeted for and approved from the onset.
Through the various stages of the project’s life cycle, incremental changes to the clinical trials, modifications and additional work that will have to be performed are inevitable. This has to be factored and adopted into the overall budget, project flow chart and clinical research design model. Failure to forecast, budget, allocate resources and configure the core clinical database for the incremental project tasks can prove to be fatal, time consuming and costly in the long-run.
The implementation plan adopts all the clinical trial project set criteria originally defined in the clinical trial project plan. Implementation plans by nature are intended to layout the road map for the successful adaptation of the project’s goals and objectives within defined clinical trial milestones, FDA compliance and regulatory standards. In this instance, the goals and objectives are to develop and refine a new pharmaceutical product for human consumption and corresponding treatment.
The implementation plan must therefore have a clearly defined framework to track the evolution of the proposed pharmaceutical product throughout the various stages of the product’s life cycle; from the product concept, laboratory formulation and controlled clinical testing to the market launch phase.
Once the pharmaceutical product has received final FDA regulatory approval and has been launched in the marketplace, efforts are made to extend the product’s life cycle. This is often achieved by introducing the product to other consumer treatment markets and adopting additional consumer applications. In many instances, the pharmaceutical product can also be enhanced, by positioning it with complimentary pharmaceutical or herbal products and human applications or treatments.
For example, the pharmaceutical product can be introduced originally as a pill and can evolve into a patch for ease of use and novelty. The ever changing evolution and adaptation of the pharmaceutical product not only extends its life cycle but also permeates the maintenance and market acceptance of specific price points.
Performance Mechanisms to Derive Human Labour
Performance Mechanisms to Derive Human Labour Rewards & Gains
A human being is motivated to perform and is stmulated by the recognition and rewards they will receive as a direct result of their personal involvement and contributions towards a function, be it for profit or non-profit oriented.
It is outside the scope of this article to quantitatively and qualitatively measure the inputs that trigger behavioral stimuli and derive the resulting human responses with respect to physical or intellectual labour contributions.
There is a difference between a human being stimulated and in turn being rewarded and/or compensated for their labour contributions, versus the measures that have to be in place to ensure that such rewards / compensations are recognized, measured and fall within regulatory guidelines.
The human being must be compensated for their basic and defined labour and contributions. The human being should also be encouraged to invest incremental physical and intellectual labour in order to excel and advance individually as well as humanity and their society in general. In return, the human being should receive either personal recognition from the society for which the human made the incremental investments of their labour, and/or measurable compensation that improves their well being and standard of living.
The onus should not only lie on the human being to disclose their personal future gains and potential earnings from the successful result of a project. In fact, the human being should not be discouraged from establishing specific and quantitatively measurable, traceable and audible personal gains for their labour contributions. The responsibility to provide the mechanisms to facilitate disclosure of a human being's personal future gains and potential earnings should also rest with the corresponding society and the established entities/organizations and institutions within that society - where the human being is committing to contribute their physical and intellectual labour.
A human being's financial rewards for their labour contributions should be encouraged. These financial rewards can be tracked and audited by various means. With respect to publicly trading companies, the SEC, Canadian equivalent OSC as well as EU regulatory bodies have clearly defined guidelines for insider trading and corresponding filing of disclosures. Ignorance of the laws of governance is not an excuse for breach of conduct or regulatory violations. This applies not only to individuals involved in the clinical trial project management function, but also for any and all citizens residing in the regulated jurisdictions.
Properly established project management mechanisms have to be adopted, that can remove any external biases in the inputs and contributions to said project. Given proper Data Management, SOPs, GCP, QA and QC measures and procedures are in place, decreases the potential of intentional or unintentional human intervention and resulting errors in the project results.
Moving in the direction of applying standardized and established project management protocols as well as procedures, can effectively measure the project's outcome, filter any biases and permit a human being to reap the rewards and/or compensation for their labour contributions. Under such a mechanized system and managed environment, human beings will be motivated to perform. They will be stimulated by the recognition and rewards they will receive, as a direct result of their personal involvement and contributions towards a clinical trial or related project, be it for profit or non-profit oriented.
Global Harmonization of Regulatory Systems
GLOBAL HARMONIZATION OF REGULATORY SYSTEMS
With respect to bringing international regulatory systems in line with one another, we must distance ourselves with geopolitical boundaries and focus on the industry and its corresponding products and services from a global perspective.
It is true that the EU has generated a powerful momentum and critical mass in adopting intra-EU member state standards and regulations. This in turn is evident in its harmonization of medical device regulation. It is also a fact that the EU model is being sited as the basis and platform for adoption in other geographic regions, notably Asia – ‘Pacific Rim" - and ‘most’ G8 countries.
The long-standing euphemism is: "Do not let the tail wag the dog!" The US is undergoing a dramatic transformation in every aspect of its essence and infrastructure. I will not dwell or invest time in quantitatively and qualitatively comparing the evolution of various empires throughout the history of human civilization and their struggle to evolve at the latter stages of their societal evolution’s life cycle, in the midst of imminent implosion!
I can state with strong basis that the US will further become entrenched in its isolationism for an indeterminable time frame. This will impact the pharmaceuticals and medical services sectors within the Continental US, and correspondingly their governing bodies. The FDA and medical regulatory agencies in essence will be experiencing the trauma and struggle, equivalent to a child facing a recent separation; a struggle between its US maternal influence and the rest of the outside world.
With respect to mutual recognition agreements (MRAs), investors will be drawn towards those for-profit organizations that can demonstrate the greatest market reach. Given that each medical device has a finite use within given populations, it makes business sense that venture capital will be directed to those corporations that have the greatest geographic coverage and diversified market potential; maximizing the medical device’s market use and extending its product life cycle.
Companies that separate themselves from insular regulatory policies and embrace internationally harmonized regulations, are open to a market penetration that is directly related in size to the corresponding global, geographic and geopolitical boundaries. This will also downgrade and offset the venture capital measurement, focus and impact on cost-effectiveness; that certain data—most importantly, data on cost-effectiveness, relative effectiveness, and medical outcomes—should be required as part of the product approval process.
New Drug Discovery Methodologies
Information technology and computational systems have advanced the facilitation of finding new and improved drug and chemical products. This in turn has increased and accelerated simultanteously the volume and quality of research data available for processing, disseminating, analysing and implementing new and potential drug and chemical products for clinical testing on animals and humans.
The role of the Clinical Data Manager in turn will continue to evolve, embracing the new information technology and computational system needs, requirements and concurrent adminitration and management of clinical trials. This entails the CDM acquiring new skill sets to maintain a firm grasp and understanding of the system requirements, research capabilities and data output processes.
The CDM will also be required to adopt these information and technology advances while simultaneously incorporating intranet and web based information exchange and retrieval mechanisms. Ultimately the CDM will have to continue to lead the clinical trial process in adherence to regulatory guidelines, rules, regulations and in adherence to quality assurance and good clinical research practices. This has to occur within the above noted constantly changing information data management environment.
ANATOMICAL PATHOLOGY BUSINESS ANALYSIS CASE STUDY
ANATOMICAL PATHOLOGY
BUSINESS ANALYSIS
CASE STUDY
IMPLEMENTATION STRATEGIES
Dean C. Bouridis June 2009
1.0 CASE STUDY OVERVIEW
The Anatomic Pathology Laboratories are taking a hard look at how to improve their standing in the market. Given the current industry trend of consolidation, where a few laboratories increasingly dominate the market, and where reimbursements are under pressure, opportunities to increase capacity, enhance revenue, and mitigate liability are scarce.
Clinical laboratory testing is generally categorized as either of two general areas - clinical testing and anatomical pathology testing. Clinical and anatomical pathology procedures are frequently ordered as part of regular physician office visits and hospital admissions in connection with the diagnosis and treatment of illnesses. As such, clinical laboratory analysis is one of the most important sections of medical care.
The purpose of this laboratory systems integration is to facilitate the specific segments of the clinical laboratory analysis business.
1.1 Challenges of Anatomic Pathology
The most significant challenges faced by clinical laboratories are a consolidating marketplace, workflow inefficiencies, and risk of liability.
Laboratories in a Consolidating Marketplace
For laboratories, the marketplace has been consolidating in favor of a few, large laboratories. Managed care has driven consolidation, which results in potentially lower revenues. As profits decrease, opportunities for growth and differentiation are reduced, making it difficult to stay competitive.
Workflow Inefficiencies
The challenge of staying competitive in an environment of decreasing revenues makes lean operations and standardization crucial, yet challenging, components of decision making. For example, shortage of pathologists in one lab results in a backlog and five-day turnaround time. A competing lab offers a two day turnaround time and is therefore able to market this improved efficiency and gain new business.
Increased throughput capacity is needed, but staffing issues make the process daunting. New technologies are needed that address staffing shortages in the lab, and thereby improve workflow inefficiencies.
Risk of Liability
Risk mitigation is achieved by meeting the standard of care. The standard of care is determined by expert testimony in malpractice suits based on several factors that include customary practice in similar situations, medical textbooks, peer-review literature, practice guidelines issued by professional societies, and any other reliable and relevant sources of information.
Advances in healthcare technology that raise the standard of care are important to track and evaluate in terms of risk mitigation. Laboratories may have an increased liability risk if the highest standard of care is not offered. Test litigation falls into two general categories: process errors and interpretation errors.
1.2 Adaptation of the Anatomical Pathology System
While many new technologies are often put forward as solutions, laboratories tend to review and evaluate only those technologies that may actually help them increase revenues, lower costs, broaden test offerings, improve quality standards, reduce risk, and, as an added bonus, increase workflow efficiencies.
To design new features and functions for Anatomic Pathology, we will focus on the successful configuration and deployment of the Anatomical Pathology system across all laboratories.
2.0 LABORATORIES POSITIONING
2.1 Laboratory Patient Care
The hospital laboratories traditionally provide a mix of inpatient and outpatient services in hematology, histology, blood banking, and anatomical pathology. Outpatient services represent the bulk of the department's volume; coverage for ambulatory services is provided daily. Lab stations may be considered as part of ambulatory centers if such a strategy is pursued. The outpatient lab area includes draw/specimen collection rooms. It is likely that laboratory outreach programs with long term care and community based agencies will increase in the future.
Lab process redesign efforts using LEAN methodology are currently underway throughout. It is likely that the analytic area of the labs will benefit from the transition to LEAN configuration within the next two years. Specific space implications include likely reduction in storage needs and cell station set-up for the analytic areas. Users should be consulted about LEAN specifications for lab design as part of programming efforts.
Pneumatic tube access for the lab is critical. If stations were established in ambulatory centers, pneumatic tube access would also be required to send specimens back to the main lab for analysis. Wet tissue samples and slides are currently stored on-site and must be retained for up-to 20 years. On off-site storage strategy could be used for these materials provided retrieval systems were executed and a controlled environment could be maintained.
Laboratory leadership believes the current blood bank area is sufficiently sized and functional. A staging area should be developed to include space for computer access, label printer and specimen preparation. The area could be dedicated or collocated with the Communication Centre provided
sufficient space is available for this function there. Proximity to the pneumatic tube station is essential to facilitate movement of specimens between the ED and central labs.
The analytic area of the hospital labs should be secured using proximity cards or some other appropriate physical barrier to prevent visitors from accidentally wandering into this space.
2.2 Deployment of Anatomical Pathology System
Built for pathologists, the Anatomical Pathology - information technology solution enables pathologists to adapt to and deliver clinical leadership in this ever-changing healthcare environment. The application uses industry-leading technologies to facilitate tissue and cellular processing, examination, and resulting and reporting.
The information technology solution will build the case for personalized medicine by demonstrating how molecular diagnostics as well as clinical laboratory data obtained through medically necessary testing, impacts patients.
An Anatomic Pathology system will:
- drive a more efficient workflow
- enable pathologists to produce concise and clinician-interpretable patient results
- embed and automates historically manual processes
- deliver information in a comprehensive, case-centric format
- utilize positive patient identification (PPID) to drive patient safety and efficiency across the health system
- incorporate "how to" sessions showing how functions such as rules and post-conversion maintenance
- address the emerging trends in inspection and accreditation procedures in the laboratory
3.0 IMPLEMENTATION STRATEGIES
3.1 Evaluating New Technology
Investing in the Anatomical Pathology - information technology solution is an important part of staying competitive with potentially positive impacts on growth, risk, and patient outcomes. When evaluating new laboratory technology, there are several important issues the Business Analyst has to consider.
The project objective is to provide "personalized medicine" and the intersections between the emerging field and the electronic health record. This entails the planning for and executing projects to meet business and patient safety objectives.
3.2 Business Analysis Project Scope:
Within the scope of this project the Business Analyst will examine the Anatomical Pathology - information technology solution:
1. How the technology is utilized to mitigate key risk factors such as errors in patient identification and delays in report availability
2. What's available and what's on the in automation and patient safety, including interfacing with processing devices as well as new labeling technologies, such as engravers and 2-D bar coding
3. Integrating data from multiple sources into a single patient record (inbound results)
4. Training - as new technologies emerge or become available, how do you build the necessary skill sets
5. Imaging
Evolving Standards of Care:
- Is the standard of care advancing in a particular field?
- Does the peer-reviewed literature and regulators support the advance?
- Do patients and stakeholders expect the highest standard, and if so, what is the liability risk of not upgrading?
Patient Outcomes:
- What effect will the new technology have on patient outcomes?
- Will outcomes improve, stay the same, or worsen?
Workflow Efficiencies:
- What impact will the new technology have on workflow efficiencies?
- Will it increase capacity?
- What effects will it have on human resources in terms of recruitment, retention, and retraining?
- Will it improve operations?
- Can the technology be incorporated into a lean operation?
Differentiation:
- Does the technology allow you to stand out from other laboratories in the area?
- Is it a marketing differentiator?
3.3 Working with the Technology Partner:
Does the Anatomical Pathology - information technology solution have a proven implementation team that will analyze specific business needs and customize the solution to meet them?
3.4 Support Resources:
Does the Anatomical Pathology - information technology solution provide support resources for marketing, training, and educational opportunities?
Greater accuracy is based on a statistically significant improvement in sensitivity and a statistically significant improvement in specificity of the individual clinical trial. False-negative reduction is based on a statistically significant improvement in sensitivity.
3.5 Patient Benefits:
Providing additional tests represents an improvement for patients in terms of convenience and quality of care.
4.0 DELIVERABLES
The objective is top increase the laboratory throughput capacity. This can have a positive impact on turnaround times, consistency, standardization, reproducibility, and growth.
The Business Analyst:
- Conducts, and directs the analysis of business problems to be solved with automated systems
- Partners with users to identify, evaluate, and develop systems and procedures, which are, cost effective and meet functional requirements
- Plans and executes unit, integration, and acceptance testing
- Creates specifications for systems to meet business requirements
- Designs details of automated systems
- Leads cross-functional linked teams to address business or systems issues
- Plans, conducts, and directs the analysis of business problems to be solved with automated systems
- Partners with users to identify, evaluate, and develop systems and procedures which are cost effective and meet user requirements
- Plans and executes unit, integration, and acceptance testing
- Creates specifications for systems to meet business requirements
- Designs details of automated systems
- Leads cross-functional linked teams to address business or systems issues
- Enhances efficiency through customizable pathologist workflow
- Improves diagnostic processes and pathologist interpretations
- Provides convenient, immediate access to comprehensive patient data
- Decreases diagnosis delivery turnaround time
- Eliminates errors and redundancy caused by recording results via paper or recorder
- Improves transcription workflow
- Increases revenue through efficient, accurate coding and charge capture
- Lowers total cost of ownership
5.0 QUANTITATIVE & MEASURABLE RESULTS
Laboratories today face many challenges. Revenue generation and competitive differentiation are key to their success in overcoming those challenges. The proposed systems integration and implementation overcomes many of the inherent challenges of a consolidating marketplace, workflow inefficiencies, and liability. is advancing the standard of care in anatomic pathology and thereby creating a positive impact on both
patient and business outcomes.
The Business Analyst will continue to evaluate the development of new technologies that will address the needs of anatomic pathology.
5.1 Functional Next Step
Performing a business needs assessment is a powerful method to diagnose workflow inefficiencies and identify opportunities for improvement and growth.
What to look for in the Anatomical Pathology - information technology solution:
1. Deliver current, evolving standard of care
2. Improve patient outcomes
3. Expand capacity
4. Improve workflow efficiencies
5. Provide a business needs assessment and support throughout implementation
6. Support resources will make a significant contribution to patient screening and patient management
7. Flexible task-driven workflow engine
8. Full patient context with embedded dictation and transcription workflow
9. Encoding and mapping to medical standard codes
10. Common terminology manager
11. Comprehensive, accurate activities-based costing
12. Bar-code label solution to enhance patient safety
13. Integrated clinical pathology results
14. Common platform and service methodology
