Maurice A. Ramirez, DO, CNS, CMRO

Entrepreneur Heal Thyself

As the practice of medicine becomes more and more the business of medicine physicians find themselves with an ever widening view of the market based world. Some physicians retreat into practices where they need “only practice medicine” and allow others to “deal with the business side.” Other physicians choose to “take the bull by the horns” and manage their own enterprise. Others choose to diversify their entrepreneurial interests. Physicians who move from the entrepreneurial world of running a medical practice to non-clinical entrepreneurism fall into two categories:

First are those that find a non-medical outlet for their entrepreneurism. These physicians often really want out of medicine, but have spent a career contributing and do not want to feel that they no longer matter.

Second are those that find a medically allied entrepreneurial endeavor that allows them to use their hard earned knowledge and skills to support themselves without the problems and challenges of direct clinical practice.

Physicians in each category often continue to practice medicine either to supplement their income, or because the financial freedom provided by no longer depending on medicine for financial security now allows them to make the decision to practice thus restoring joy to medical practice. 

Paging Dr. Experience
The entrepreneurial life of running a medical practice is much the same as that of running a start-up business. The only significant difference is that a medical practice runs on a larger budget initially, but a smaller budget and profit margin later on. Non-medical start-ups usually begin with marginal funding and, if successful, grow as their income grows eventually reaching a point where their budget and profit margins are both quite respectable.

Because of their leadership role in healthcare, physicians are drawn to business leadership and executive positions. When it comes to physician executives, there are two types of “CEO’s.” Those whose lives present them with a never ending string of Career Ending Opportunities (CEO’s) and those who have learned to apply the skills that made them great doctors to lead organizations rather than medical teams. This latter group of physicians apply Business Triage, Customer Triage, Personnel Triage and Marketing Triage to maximize business potential in the same way they used medical triage to maximize patient care.

Physicians entering the entrepreneurial life must however observe several lessons:

• Do not assume your success in medical practice carries any weight in your new market. Be a good entrepreneur, know your market, know your strengths, know your weaknesses and know how to deliver your commitments

• Do not forget the skills that made you a good doctor. The skills that made patients love you and diseases fear you (effective interviewing, rapid decision making, pattern recognition, etc.) all are essential skills for the entrepreneur

• Don’t assume that medical training (residency) is a good model for training anyone or learning to lead. As a survivor of residency training, you are no different from a child abuse survivor and you are prone to abuse those subordinate to you as a result. If you abuse them, you lose them

• Just like a good doctor, good entrepreneurs make referrals, get consults and ask for help these are the keys to success

Physicians, despite the stereotypes, have education and experience that endows them with many of the skills of the greats of the corporate world. The key is to learn to use these skills in the new environment of entrepreneurism.

Outrage or Enthusiasm: The Choice is Yours!

Businesses large and small want happy customers, happy employees and happy vendors. Regardless of whether a multinational corporation or a “Mom & Pop” store, enthusiastic supporters are a marketing asset while a single outraged person is a liability. Studies have shown that the average “satisfied customer” refers five people while the average “dissatisfied customer” finds 11 people to chase away.

Businesses and whole industries spend huge sums of money meeting customer expectations and even larger sums of money raising those expectations further. It is a never ending chase and if you lose, twice as many people will hear from the disappointed than ever heard from the content.

The key then is to manage the factors that determine the satisfaction of customers, employees and vendors with their experiences interacting with a business.

Let Your World PIVOT Around Them!

When people are born, they believe that they are the center of the universe. As children grow and mature into adulthood, they slowly learn that the world does not revolve around them. Businesses seek as part of their customer service approach to make customers feel that again the world revolves around them. Rather than reverting to childhood, a business seeking enthusiastic supporters should make the experience PIVOT around them.

The PIVOT model provides a simple mathematical approach to understanding and even predicting the societal and individual response to an experience. The PIVOT model is another lesson learned from the disaster field office. PIVOT stands for:

P = Probability

I = Impact

V = Vulnerability

O = Outrage

T = Tolerance

Each component of the PIVOT model places a numerical value on the factors that determine the response to the experience a business provides. It is a predictor of “Customer Satisfaction.” To apply the PIVOT model each component must be understood.

Probability

Probability = The likelihood of an experience occurring (0% to 100%)

Drawn from traditional risk management and actuarial sciences, the probability of an experience or event occurring is a value based on the historical frequency of an experience or event occurring. Most simply, probability is the number of times an experience or event occurs divided by the total number of possible experience and events.

Impact

Impact = The impact of an experience (positive or negative) on a scale 0 to 3

(0 = No Impact; 1 = Minimal Impact; 2 = Moderate Impact; 3 = Significant Impact)

It is often said that no event or experience is without impact, but assigning a value to the degree of impact is often complicated. The PIVOT model deals with response to an experience or event and is inherently subjective, thus Impact is a subjective measure based on past occurrences of the experience or event.

Vulnerability

Vulnerability = The susceptibility to the impact on a scale 0 to 3

(0 = None; 1 = Minimal; 2 = Moderate; 3 = Significant)

Like Impact, Vulnerability is a historically based, subjective measure of the susceptibility to the Impact. Obviously, if something has occurred previously but had not Impact, the Vulnerability is zero; however, when an Impact has occurred in the past, people have an inherent and subjective sense of Vulnerability which can be subjectively measured.

Outrage

Outrage = The perception of the experience on a scale -3 to 3

Outrage was first identified as a component of risk communications by Paul Sandman, PhD. In his model, Sandman identified two factors that influenced and predicted the need for risk communications in the event of a business debacle, Hazard & Outrage. Sandman found that while a high perceived Hazard necessitates risk communication, low Outrage mitigated that need while high Outrage necessitated risk communication even with a low perceived Hazard.

Sandman never quantitated the level of Outrage, but in the PIVOT model, Outrage is a calculated value. Calculation of Outrage requires an understanding of two additional values, Expectation and Satisfaction.

Expectation = Perception of what reality SHOULD BE on a scale 0 to 3

(0 = None; 1 = Minimal; 2 = Moderate; 3 = High)

Satisfaction = Perception of what reality ACTUALLY IS on a scale 0 to 3

(0 = None; 1 = Minimal; 2 = Moderate; 3 = High)

Understanding Expectation and Satisfaction, Outrage can be calculated:

Outrage = Expectation – Satisfaction

The interesting result of calculating Outrage is the insight this provides. Since Expectation is the perception of what reality should be and Satisfaction is the perception of what reality actually is, and given that a business cannot change people’s perception, Outrage is actually the difference between Expectation and REALITY.

Tolerance

Tolerance = The sentiment regarding the experience or event.

Tolerance is the measure degree of Enthusiasm or Anger in response to an experience or event and like the calculation of Outrage, calculating Tolerance gives tremendous insight into why seemingly bad business news results in good while seemingly good business news can become a full fledged business disaster. To calculate Tolerance, first calculate Hazard and Risk.

Hazard = Impact + Vulnerability

Risk = Probability x Hazard

        = Probability x (Impact + Vulnerability)

Having previously calculated Outrage and now having quantitated Risk, Tolerance is simply calculated, noting that if Outrage is a negative number, the positive number (absolute value) is used to calculate Tolerance.

Tolerance = (Risk)^|Outrage|

Therefore Tolerance (anger or enthusiasm) equals Risk raised to the power of Outrage.

Choosing Epidemic Enthusiasm

A look at two classic historical business examples demonstrates how accurate and powerful the PIVOT model is for influencing public and individual sentiment.

McNeil Pharmaceuticals is the textbook example of risk communications after the cyanide contamination of their Tylenol product. Applying the PIVOT model, the probability of dying from a contaminated pill 100% and the impact if such an event occurred and the vulnerability were both high thus each scoring 3 points. Calculating for Hazard and Risk yields a Hazard score of 6 with a Risk score of 6. The Expectation of the general public was also high (3 points) as there had never before been a significant problem with a McNeil product.

When the company responded by publically withdrawing the product from the market and pledging to not return to store shelves until safety could be assured, Satisfaction was moderate (2 points). But, when McNeil made good on their promises, Satisfaction was high (3 points). Outrage, which could have crippled the company’s return to the marketplace, was effectively reduced to zero.

When Outrage is zero (Expectation = Satisfaction), the Tolerance score always equal to 1. (Mathematically, any number raised to the power of zero equals 1).

The textbook contrast to McNeil / Tylenol is New Coke / Classic Coke. The Coca-Cola Company dominated the cola market for decades when market research began to show that Pepsi cola was eroding a small percentage of Coke’s market share. In a carefully researched and planned effort to regain that small market share loss, the Coca-Cola Company reformulated Coca-Cola. Again applying the PIVOT model, the probability of bringing the new product to market was 100%, but market research and focus groups had found that the Impact would be minimal (1 point) although the Vulnerability to the Impact moderate (2 points). Calculating or Hazard and Risk yields a Hazard score of 3 and a Risk score of 3.

When the new formulation arrived on store shelves, Expectation was high (3 points), but Satisfaction with the new formula was nonexistent (0 points). The Tolerance score of 27 predicts what followed. Consumers began to hoard “old Coke” and picket against “New Coke.” Re-examining the anticipated Impact and Vulnerability shows that loyalty to the taste of the “old Coke” formula meant that the both Impact and Vulnerability were actually each 3 points, thus Hazard was 6, Risk was 6 and Tolerance was 216 (highest possible score). Despite the reintroduction of “old Coke” as “Classic Coke,” it was years before the Satisfaction score rose and the Tolerance score exponentially fell.

When Outrage is a positive number (Expectation > Satisfaction), the Tolerance score is a reflection of the Anger (negative image) felt towards the business.

But this is not the end of the New Coke / Classic Coke story. An unintended, but not unexpected beneficiary of the Coca-Cola Company’s misstep was Pepsi cola. Regardless of the success or failure of the new Coca-Cola formulation, the probability of the product making to store shelves was 100%. Had Coca-Cola’s market research been correct, the Impact on Pepsi cola would have been high (3 points) and as the number two product in the marketplace, Pepsi’s vulnerability was also high (3 points). Pepsi cola had a lot riding on Coke’s reformulation with a Hazard score of 6 and a Risk score of 6.

When “New Coke” disappointed Coke consumers, Pepsi consumers were heartened by the fact that Pepsi was NOT being reformulated. The Expectation for a change in flavor was nonexistent (0 points) while Satisfaction remained high (3 points). For Pepsi cola, the Outrage score was negative (-3) yielding a Tolerance score of 216, but unlike Coca-Cola customers, Pepsi customers were predictably enthusiastic about their preferred product. Same event, same reality, different outcome based on perspective and expectation.

When Outrage is a negative number (Satisfaction > Expectation), the Tolerance score is a reflection of the Enthusiasm (positive image) felt towards the business.

Manage What is Manageable

Ultimately, Probability, Impact, Vulnerability, Perception and Reality cannot be changed. Of all the factors that determine public and individual sentiment and predict anger verses enthusiasm, Expectation is the only factor that can be changed before and to a lesser degree during an event or experience. Thus if Expectation can be preemptively made to matched reality, Outrage is changed. Through expectation management, Anger is downgraded to Concern; Concern is converted to Opportunity; and Opportunity is upgraded to Enthusiasm.

Death of the Dinosaur, the New Economy of Information and Process

Since the inception of the industrial era, business has moved in what Bhatt has referred to as the “sell/buy” approach.  In other words a business, corporation, or even street vendor offers products for sale and the consumer purchased them.  Marketing, advertising, branding and all other endeavors of business were designed to support this “sell/buy” mentality.  Madison Avenue soon learned that the product was more important than the customer and the only part of the customer that truly matter was the customer’s willingness to pay for the product.

Steven Bhatt calls this form of business entity, Economus corporatus literally “market of bodies”.  Bhatt states that if business entities are thought of as species, then Economus corporatus is a dinosaur born of the Industrial Revolution and the age of the dinosaur is over.  Just as at the end of the Mesozoic era, the K-T asteroid struck the earth causing the mass extinction of dinosaurs.  The world economy as seen two separate K-T type asteroid impacts on the global marketplace. Much as the first K-T asteroid heralded the death of the largest reptiles to occupy this planet, the economic K-T asteroids now herald the death of Economus corporatus. 

What are the K-T asteroids of the modern economy?  The first of these is the rise of what is commonly now known as the information age.  The growth of the internet as well as the continuous and exponential growth of computing power, storage and most importantly bandwidth has transformed the market place and the very currency of market economies.  In the industrial era the market place was dominated by product-based companies typical of species Economus corporatus. 

Yet scurrying amongst the trampling feet of these Paleolithic behemoths of industry were the early warm blooded small service-oriented businesses.  As the industrial era waned, giving rise to the service and information economies of the 1980s and 1990s, the number of these small service-oriented businesses grew exponentially.  Finally, the availability of technology to support the exchange of information required to facilitate the explosion of service and information-based businesses vibrated as the first of the economic K-T asteroids impacted the world marketplace, the information age was born. 

The second K-T asteroid of the world marketplace was the widespread availability and increasing density of communications and bandwidth.  Now, not only was an incalculable volume of information available but it was available to everyone.  Services such as Wikipedia, Big Dig, and other community based, community monitored, community edited, community generated, public domain/communal information repositories all but obliterated the meaning of intellectual property.  With the impact of this second K-T type cataclysmic asteroid on the global marketplace, the end of Economus corporatus was assured and the small information age industries that had scurried among its feet evolved into what Bhatt calls Economus processus, literally “market of collaboration advancing information and relationships.”

For species Economus processus, words that were once nouns to Economus corporatus are now verbs.  Business, start-up, information, and even relationship no longer define static objects to be owned or claimed by a single member of species Economus corporatus.  Instead they are now verbs, action words that describe the activity of a member of the species Economus processus.  Economus processus is involved in the activity of business. Rather than being a startup, a newly born Economus processus goes about the activity of starting up.  To Economus processus information is not an object to be horded and jealously guarded from the eyes and fingers of other members of each species, rather information is a process by which relationships, connections, products and services are spawned, nurtured, delivered and even inspired by the very people and corporations that the information serves and supports. 

Economus processus does not go to networking events to create relationships that are then placed in a rolodex like so many forgotten business cards.  Rather Economus processus builds and nurtures relationships as ongoing forms of communication, even as friendships.  The relationship itself is not an end but a means by which Economus processus serves others.  There is no longer a “sell/buy” mentality, instead there is only the process of building relationships that lead to the collection of more information that promotes mutual success.

Bhatt states Economus processus is only a recent evolution, however there is evidence that as early as the 1970’s the corporate genetics for Economus processus were emerging. Cavett Roberts, the founder of the National Speaker’s Association observed that his colleagues in the field of professional speaking were competing for business from a never expanding pool of potential clients. As the number of professional speakers grew, each was competing for an ever shrinking piece of the pie. Roberts determined that it was not the speech (product) that clients bought, but the act of professional speaking (process). This meant that if professional speakers shared market experiences, insights and efforts, new markets could be opened to the profession of professional speaking. New markets would create an ever expanding pool of potential clients and, as Cavett Roberts often said, “we make a bigger pie.”

Bhatt contents that given the rapid expansion of the internet and technology in general, Economus processus is poised to become the dominant species over the next five years and will maintain that dominance for the foreseeable future. While there is no doubt that Economus processus is rapidly gaining dominance as Economus corporatus suffers death spasms and collapses under the weight of its own structures, hierarchies and sheer mass, it is not at all certain that Economus processus represents an endpoint in its own evolution. 

Already, there is a new species evolving out of Economus processus and the market is moving quickly to embrace this new and even more nimble member of the global market, Economus paratus literally “market ready.”  For Economus paratus, business, start-up, information and relationship are not only verbs, but processes to be supported by the judicious allocation of resources, in other words Economus paratus takes the best of the lessons learned from Economus corporatus and applies them to the verbs that define Economus processus.

Economus paratus, despite the fact that it is only in its infancy, has already had its birth cries heard across the world and across the internet.  Economus paratus first birth cries were of the concept of business triage, the model by which outcomes are identified and the processes supporting these outcomes prioritize benchmark monitor and given resources to ensure the desired outcome.  Such a business triage model can only function in a truly cellular organization, that is an organization in which, as Bhatt describes, management sets goals (outcomes), budgets and boundaries then teams within the organization establish the rules and paths by which these outcomes are achieved. 

Within a particular cell, leadership, duties, roles and function are determined not by management but by the team as a whole. Working under a team selected leader to achieve the goal in the most efficient and cost effective fashion within the boundaries and budgets set, these cells function more efficiently, more economically and faster than their structured, hierarchal and micro-managed competition.

Economus paratus does this in the most efficient way possible by first establishing the most important outcomes and then allocating resources judiciously to achieve them. In short, business triage and process optimization are distinguishing characteristics of Economus paratus.

While Bhatt is certainly correct that Economus processus will become the dominant business species within the next five years, there is no doubt that it will share the global marketplace with Economus paratus and that within a decade it will be Economus paratus and not Economus processus that achieves true and complete dominance.

A Homeland Security Role for Vitamin B12

Research into transmucosal absorption of intranasal Vitamin B12 gel supports a significant absorptive capacity for Vitamin B12 by this route.  Given that the mucosal thickness of the intranasal mucosa compared to the sublingual mucosa is approximately the same in that mucosal vascularity is also approximately the same such dispirit results between the two routes would not be expected based on a pharmacokinetic difference alone.  Given that both areas are supplied by branches of the carotid artery and therefore have the same flow rates, vascular profusion also fails to explain the disparity of results that is in fact seen when these routes are compared.  The most logical and obvious explanation is that the intranasal administration allowed for a retention time greater that found sublingual administration of Vitamin B12 gel.  This “holding time” allowed for a greater absorption of the Vitamin B12 gel.

Although this has interesting implications for the treatment of Vitamin B12 deficiency in a number of patient types including those with Dumping Syndrome and Pernicious Anemia, all other patient populations with Vitamin B12 deficiency have been shown to be adequately supplemented by high dose oral Vitamin B12.  The intranasal use of Vitamin B12 gel does represent an opportunity to treat those patients for whom oral Vitamin B12 is either unacceptable as an administration route or ineffective due to decreased intestinal transit time or the lack of intrinsic factor.

Of far greater potential if the application of this research to the treatment to cyanide poisoning.  The incidence of cyanide poisoning as an industrial exposure continues to this day to be a significant occupational risk worldwide.  Although that risk is significantly lower in industrial countries due to the shift to a more technological economy third world countries continue to use large volumes of cyanide and its conjurers in the manufacturer of precious metals and the processing of gemstones and other products.  The most famous of these accidents occurred in Bhopal, India in 1984 when 40 million tons of methyl-isocyanate was inadvertently released by a union carbide plant worker.  The number of casualties quickly outstripped the medical capabilities of the local community and the casualty rate both in disabled and dead was astronomical.

The loss of the amyl nitrate based cyanide treatment kit has created a void in the continuum of care for cyanide exposed patients.  The amyl nitrate based cyanide treatment kit allowed for a bystander with no medical training to read simple picture based instructions and administered the first, life sustaining step in cyanide treatment.  In many cases individuals exposed to cyanide can self treat in using this first amyl nitrate based step since it required only that the amyl nitrate ampoules be open and poured on gauze or another cloth which could then be held to the face and the medicine breathed in.

The new Vitamin B12 based cyanide treatment kit, while safer, requires the reconstitution of powdered Vitamin B12 and administration by use of an intravenous infusion.  While this is relative simply procedure for an experienced health care professional it is beyond the reach of most bystanders and prohibitly difficult if not impossible to be performed by cyanide exposed individuals upon themselves.

Transmucosal administration suggests a potential solution that will fill the void between immediate field care between cyanide toxic related toxicity and dissentative intravenous care using Vitamin B12 base cyanide treatment kit. The volume of Vitamin B12 gel required would exceed that reasonable for intranasal use, but an intrarectal route would provide both adequate volume capacity and holding time.

Currently there are several intra-rectal treatments utilized in toxicology and emergency medicine.  Intra-rectal diazepam is utilized for the treatment of seizures by school nurses, parents and in a limited number of situations by patients during their pre-seizure aura.  Kayexalate is utilized extensively for hyperkalemia whether a result of renal failure or muscular injury from glass or crushed trauma intra-rectal kayexalate.

In both of these treatments volumes of medication between ten and 120 milliliters are instilled and retained in the rectum allowing for the absorption of medication across the rectal mucosa.  Like the intranasal mucosa the rectum mucosa is relatively thin and of approximately the same vascularity and profusion rate.

The scientific literature suggest that a Vitamin B12 gel at a concentration similar to that described in multiple British research projects (15 to 20 milligrams per milliliter) would result in a dose comparable to half of the total Vitamin B12 based cyanide treatment kit.  This dose of 1.8 to 2.4 grams could be repeated in four hours allowing for the administration of the entire recommended 5 gram Vitamin B12 dose for moderate to severe cyanide toxicity within the recommended six hours via the rectal retention method alone.

Although further, more specific research on the utilization of high dose Vitamin B12 intra-rectal gel in the treatment of cyanide toxicity would be required before a definitive recommendation could be made for this route of administration; the potential of this route is clearly supported by the literature. Transmucosal Vitamin B12 may represent the missing link in the care of cyanide related toxicity both in the industrial and the tourism related exposures.

Qui Tam - Sarbanes Oxley & Disaster Preparedness

Healthcare is a business and fortunately most involved in the business of healthcare are ethical and moral people. To be sure, there are some who commit fraud and steal from the system. Many are caught and suffer civil and criminal penalties for their deliberate actions, and many more get away with fraud longer than they should.

Corporate business people are also mostly moral people. Unfortunately, the media attention to corporate fraud has lead to the proliferation of Qui Tam law suits and regulations such as Sarbanes Oxley. These worlds overlapped this year when Disaster Preparedness guidelines, corporate financial forecasts, the signatory obligations imposed by the National Response Plan (NRP) and the mandates of the National Incident Management System (NIMS) collided.

Last year a High Alert, LLC white paper had raised the specter of NRP/NIMS compliance being linked to CMS (Medicare, Medicaid and Tricare) billing, the discussion had been strictly theoretical. Several federally funded training programs have now brought to the table a new and ominous implication of the NIMS Integration Center Implementation Plan for Hospitals and Healthcare. Additionally, hospitals have reported being informed that disaster preparedness will be linked to CMS reimbursement (Medicare, Medicaid and Tricare payments). The white paper is available for download here:

Download cost_of_disaster_unpreparednessrevised_23apr07.pdf

This is the first step in a progression that, if followed by CMS, Department of Health and Human Services (DHHS), Department of Homeland Security (DHS) and Department of Justice (DoJ), will put the full weight and power of the federal government behind an unfunded mandate for hospital preparedness. An appreciation how CMS and DoJ have handled dealt with healthcare providers who have run afoul of these agencies in the past 18 months may portend the future.

In early 2006, DoJ instituted a change in how it dealt with Medicare, Medicaid and Tricare fraud. In prior years, these issues were typically dealt with as civil issues with civil penalties and restitution. Most offenders plead "guilty" or "no contest" to the charges, paid a fine and went home. Beginning in early 2006, DoJ began using the "guilty" plea from the civil cases as evidence to prosecute these individuals criminally. The type of insurance fraud spanned the gambit from billing for nonexistent patients to billing more than the documentation would support. It is this latter prosecution that is the cause of concern.

NRP and NIMS regulations are promulgated upon all signatories to NRP/NIMS, including DHHS. As signatories, all government agencies agree to promulgate the requirements of NRP/NIMS upon all their agencies/departments. Since DHHS is a signatory, this would include CMS (Medicare, Medicaid, Tricare). Since a all healthcare providers who bill CMS directly or indirectly are regulated by CMS and have independent contractor status with CMS, the requirements and regulations promulgated upon CMS by NRP/NIMS through DHHS are passed down to those contractors. This is affirmed by every healthcare provider every time they bill CMS on a UB92, CMS1500 or electronic equivalent because these forms include the attestation that the healthcare provider is in compliance with all regulations and requirements of CMS and the program billed.

It is this last fact that opens the door for DoJ to involve itself in hospital preparedness. Through their actions in 2006, DoJ has shown the willingness to criminally prosecute healthcare providers for overt insurance fraud. Signing the CMS attestation when not in compliance with NRP/NIMS is the same as signing the attestation that chart documentation is in compliance with CMS documentation standards. In short, the failure to be all hazards prepared may have just been raised to the level of a federal felony, enter Qui Tam.

Qui Tam is a provision of the False Claims Act, which allows for a whistleblower to bring a lawsuit on behalf of the United States, where the whistleblower has information that a Medicare/Medicaid provider has knowingly submitted or caused the submission of false or fraudulent claims. The False Claims Act provides incentive to whistleblowers by granting them between 15% and 30% of any award or settlement amount. In addition, the statute provides an award of the whistleblower's attorney's fees.

Once a whistleblower brings suit on behalf of the government, the United States Attorney for the district has the option to take over the case. If the US Attorney does so, the government will usually notify the Medicare/Medicaid provider being sued that a claim has been filed. Qui Tam actions are filed under seal, which has to be partially lifted by the court to allow this type of disclosure. The seal prohibits the defendant from disclosing even the mere existence of the case to anyone, including its shareholders. The government may then, without disclosing the identity of the whistleblower or any of the facts, begin taking discovery from the defendant.

Claims that are falsely presented to the Government for payment are actionable under the False Claims Act. The False Claims Act covers a Medicare/Medicaid provider who:

• Knowingly presented or caused to be presented a false or fraudulent claim for payment or approval to an officer or employee of the government;
• Knowingly made, used, or caused to be made or used, a false record or statement to get a false or fraudulent claim paid by the government;
• Conspired to defraud the government by getting a false or fraudulent claim allowed or paid;
• Knowingly made, used or caused to be made or used, a false record or statement to conceal, avoid, or decrease an obligation to pay or transmit money or property to the government, ("reverse false claim").

A hospital or healthcare facility which fails to fully implement an NRP/NIMS Compliant “All Hazards” Disaster Preparedness program and continues to submit Medicare/Medicaid claims including the attestation that the provider is in compliance with all regulations and requirements of CMS and the program billed presents or causes to be presented a false claim. A claim is "knowingly" made if:

• There is actual knowledge of a false claim
• Deliberate indifference to the truth or falsity of a claim
• Reckless disregard of the truth or falsity of a claim

The implications for the corporate officers of a hospital go beyond just CMS fraud, civil penalties and imprisonment. Hospitals are now largely operated by public entities and thus file financial forecasts and financial statements. These forecasts are based on projected CMS reimbursements. If a facility is not NRP/NIMS compliant and “All Hazards” disaster prepared, the corporate officers are not only in danger of CMS fraud, but of projecting CMS reimbursements they know are not collectable. Further, the seal on a Qui Tam claim prohibits the defendant from disclosing even the mere existence of the case to anyone, including its shareholders a fact which is in conflict with the provider's obligation under Security and Exchange Commission regulations that require disclosure of lawsuits that could materially affect stock prices, enter Sarbanes-Oxley.

The Sarbanes-Oxley Act came into force in July 2002 and introduced major changes to the regulation of corporate governance and financial practice. It is named after Senator Paul Sarbanes and Representative Michael Oxley, who were its main architects, and it set a number of non-negotiable deadlines for compliance. Periodic statutory financial reports are to include certifications that:

• The signing officers have reviewed the report
• The report does not contain any material untrue statements or material omission or be considered misleading
• The financial statements and related information fairly present the financial condition and the results in all material respects
• The signing officers are responsible for internal controls and have evaluated these internal controls within the previous ninety days and have reported on their findings
• A list of all deficiencies in the internal controls and information on any fraud that involves employees who are involved with internal activities
• Any significant changes in internal controls or related factors that could have a negative impact on the internal controls

Sarbanes-Oxley establishes an independent commission which is required to study and report on the extent of off-balance transactions. The commission is also required to determine whether generally accepted accounting principals or other regulations result in open and meaningful reporting.

Financial statements published by regulated companies are required to be accurate and presented in a manner that does not contain incorrect statements. These financial statements must include all material off-balance sheet liabilities, obligations or transactions. Regulated companies are required to publish information in their annual reports concerning the scope and adequacy of the internal control structure and procedures for financial reporting. This statement must assess the effectiveness of such internal controls and procedures. A registered accounting firm must, in the same report, attest to and report on the assessment on the effectiveness of the internal control structure and procedures for financial reporting. Regulated companies are required to disclose to the public, on an urgent basis, information on material changes in their financial condition or operations. These disclosures are to be presented in terms that are easy to understand supported by trend and qualitative information of graphic presentations as appropriate.

Sarbanes-Oxley imposes penalties of fines and/or up to 20 years imprisonment for altering, destroying, mutilating, concealing, falsifying records, documents or tangible objects with the intent to obstruct, impede or influence a legal investigation. The legislation also imposes penalties of fines and/or imprisonment up to 10 years on any accountant who knowingly and willfully violates the requirements of maintenance of all audit or review papers for a period of 5 years. Organizations may not attempt to avoid these requirements by reincorporating their activities or transferring their activities outside of the United States.

Disaster preparedness is no longer just an accreditation issue. “All Hazards” disaster planning is no longer just a requirement of qualifying for federal grants. Education is no longer a last priority. Disaster planning, preparation and education are the newest legal shield for the healthcare corporate officer.

The Unprepared Beware.

Business Continuity and Healthcare Disaster Planning

The Business Continuity profession has seen rapid and explosive growth in the days since 9/11. On that terrible day, the significant difference between those businesses housed in the World Trade Centers that would reopen and those that would close was the degree of business process resilience that business possessed.

The years since 9/11 have seen businesses large and small implementing not only data redundancy, but continuity planning for all critical business processes. To be sure, healthcare has also implemented data redundancy and business process continuity planning for business and administrative activities, but what about the true business of healthcare?

Business continuity planning is designed to preserve those critical business processes that must be preserved to maintain operations and profitability. For an investment company, those processes include data storage, client accounting and real time financial processing to mention just a few. Healthcare business contingency planning is directed at supporting such processes as data storage, client accounting and real time financial processing; but does this support the mission of healthcare?

An investment company is in the business of managing money and markets; their business continuity planning supports that mission. Healthcare is in the business of delivering medical care. Currently healthcare business continuity is split between two professionals, the business continuity professional and the medical contingency planner/safety officer. The business continuity professional is charged with ensuring that the financial and administrative processes of the healthcare business are maintained. The Medical contingency planner/safety officer is charged with ensuring that the delivery of healthcare continues uninterrupted. But the does this split approach support the mission of healthcare?

Healthcare business continuity planning must preserve those critical business processes required to maintain operations and profitability. This by necessity includes both critical medical services and critical financial and administrative processes. However, most healthcare institutions in the United States are private sector businesses. These businesses do not meet their operational budgets with emergency medical services or even general hospital admissions. This was borne out in the late 1970’s and early 1980’s when the losses in emergency medical services caused hospitals to either close or restrict services in the emergency room. In an effort to stop this trend, Congress passed the 1986 Emergency Medical Treatment and Active Labor Act (EMTALA). In 2007, healthcare institutions subsidize the unfunded EMTALA mandate with outpatient services. These are the very services that most medical contingency planners/safety officers close when disaster strikes.

Like business contingency planning, healthcare disaster planning begins with a vulnerability analysis; however, unlike the business vulnerability analysis which focuses on identifying critical business processes, the healthcare vulnerability analysis focuses on quantitating external threats. Healthcare disaster planning is based on an “All Hazards” approach. Despite the apparent emphasis on external threats, an “All Hazards” approach is meant to be “Process Hazards” approach.  Here in is the challenge for the medical contingency planner/safety officer and the new market opportunity for the business continuity professional.

Healthcare desperately needs a planning professional who can combine the healthcare vulnerability analysis with the business process vulnerability analysis. The average daily revenue loss for a hospital that closes outpatient services following a disaster is a quarter of a million dollars. In addition, financial losses occur as a result of process failures in registration, charge entry and billing. The delivery of healthcare services frequently suffers as a result of process failures during disaster that cause a backlog of patients and a loss of efficiency. Healthcare disaster planning based on standard healthcare vulnerability analysis combined with process vulnerability analysis would not only address the business process continuity, but would highlight medical process vulnerabilities allowing limited medical resources to be concentrated on medical process continuity. Finally an attention to business continuity focusing on the primary mission of the healthcare institution to deliver healthcare and maintain profitability would support the business processes and the medical processes while quickly returning to normal operations to restore all streams of revenue.

The “Choke Point” is Management

One of the lessons learned early on in the disaster field office is referred to as “span of control”.  Span of control is a two-dimensional concept of personnel and project management.  Span of control dictates both the breadth and depth that an individual leader may effectively exert control and leadership.

Decades of experience have taught us that even the most experienced project manager, leader, CEO or company president can only effectively lead a breadth of three to seven subordinate divisions and ideally the number is five.

That same experience has also taught us that a leader becomes detached if the organization they oversee grows greater than five to seven layers deep with, again, the ideal number being five for efficacy.

But why does this occur?  Why should your organization be no more divisions wide under any one leader than the number of fingers on their hand and no more layers deep in that organization than the number of toes on one foot?

The answer in part lies in the functioning of the human brain.  Immediate memory, that portion of the brain capable of receiving information almost instantaneously, less than .037 milliseconds, and maintaining it until it can be written into permanent memory is only seven blocks wide; this is why your telephone number (excluding the area code) is seven digits long.

However, just like a telephone number, by grouping batches of numbers your brain treats each group of numbers as one block.  The area code becomes one block of information rather than three discreet numbers.  The prefix, another group of three numbers, is again considered a single block of digits.  Hence a ten-digit telephone number is now treated by the brain as only six blocks of information—the area code, the prefix and each of the last four individual digits.  Similarly your Social Security number is divided into the same sequence—three-digit prefix, a two-digit place code and the terminal four digits. 

Span of control pays attention to this same basic brain limitation.  You can most effectively pay attention to five simultaneous branches within your chain of command without becoming distracted because you have two “available” blocks of memory in which to store “distractions.” 

Depth in any one branch works the same way.  When you must pay attention to one branch with any degree of specificity, your brain turns your memory “sideways” and looks at the depth in blocks of information. Limiting depth to 5 layers leaves two “available” blocks for “distractions” or to share among the other branches of your organization.

But how does this impact actual management?

Taking these decades of experience from the disaster field office and combining them with the neurophysiologic knowledge of how the human brain works, we discovered that in any organization, the organization must be subdivided when the number of first-level subordinates exceeds five.  Therefore, if a CEO must run four divisions of a single company, he can do so with four vice-presidents, but when that number exceeds seven, the company must be in some fashion broken up, grouping each of those greater divisions under individual presidents who then report to the CEO. Thus the company becomes one layer deper, but the CEO has only 2 divisions under his span of control (each with a president).

Similarly, imagine we now have one CEO with two presidents, but the organization becomes greater than seven layers deep with the seventh layer being the customers.  The CEO is in danger of losing touch with those customers.  In this circumstance, a new division in the company reporting directly to the CEO can be established that provides for information to be disseminated directly by the CEO to customers and feedback directly from customers back to CEO.

A fine example of this is seen in Zales Corporation.  Zales Corporation operates multiple divisions under multiple jewelry sales brands.  Each of these brands is grouped according to their market.  Thus, they grouped brands with each group led by a senior vice-president.  The corporate president oversees senior vice-presidents and thus their groups and brands.  The problems for Zales Corporation came when in their corporate C suite, became embroiled in a personnel problem.  This highly publicized personnel problem impeded the ability of the higher echelon of leadership to exert their span of control and required that a lower level of leadership assume a dual role.

Dual roles are death!

Worse, the individuals in duel roles supervised the same people, creating two parallel chains of command. The company and its employees were literally shackled by conflicting instructions and expectations. In the disaster field office we know that when needs exceed resources it is a disaster, but when needs exceed all ability to respond it is a catastrophe. Zales became a wounded dog because management issues (needs) exceeded their ability to respond. Investors responded to the catastrophe and stock prices fell.

Span of control dictates that one person fills one role and that even like organizations not be combined, but that if one leader must supervise two separate divisions or organizations, that that leader do so through a subordinate to whom those organizations individually report.  In the disaster field office we call this “Unity of Command” and it ensures that each individual in the chain of command knows precisely what singular individual to whom they report and from whom they take direct instruction.  With this unity of command and span of control principles in place, management issues cease to be a choke point.

Zales ceased to be a wounded dog when they corrected their C suite personnel problems, reestablishing a unity of command and a manageable span of control. Investors rewarded them with a two-fold increase in stock price in two months.

(Excerpted from my seminar series and book, Wounded Dogs: Avoiding Business Disasters – Lessons Learned in the Disaster Field Office)

The Race to a Paperless Society

It is amazing how once you notice something, you begin to pay attention and in paying attention you discover a whole new world.

Several weeks ago I wrote an article on portable medical records and the possible uses of technology to bring part of the medical records from novelty status to a mainstream medical device.  A few weeks later I was introduced to a new generation of portable medical records that were capable of synchronizing with the electronic medical records at a physician's office or at a hospital.

For those of you who are not familiar with portable medical records allow me a moment to give some definitions.  A portable medical record is a USB drive device such as a Thumb Drive, a USB wristband, a USB flash drive wristwatch, pendant, or other portable mass storage that can be worn on the body attached to a belt or keys and holds basic medical information in a database form.  Almost all these devices now are password protected and offer varying levels of functionality.

A personal health record is the online equivalent of the portable medical record.  This software exists on the Internet with storage maintained at a third-party site.  The information is again password protected and in an emergency can be accessed by the healthcare provider with an Internet connection and that password.

An electronic medical record is a software package utilized by hospital healthcare facility physicians that replaces the paper patient chart.  This is an official document and subject to significant government regulation.  By 2008 every healthcare provider in the United States must be executing concrete plans to transition from paper to electronic records and by 2014 all paper must be gone.

With that in mind let's turn now back to the portable medical records.  This is a market that is exploding.  A few short weeks ago I wrote an article, my second in this arena, that described nine products of this type.  Two days ago I did a new Google search on this topic (okay, I was desperate for an article topic) and I found no fewer than 24 companies now offering these devices in the United States, Canada and England.  Many of these devices are now being made in Taiwan and China and installed directly on the flash drives.  They are coming in every shape, size and form but unfortunately with little or no functionality.

Yes, they all have some form of password protection and an emergency screen where basic information can be seen without the use of the password.  They hold information such as living wills, organ donor cards, healthcare surrogate contracts, past medical histories, allergies, medications and a few hold greater levels of data.  Two of them integrate with online personal health records but only one can import and export to electronic medical records.

None of these systems however have one basic piece that is required for credibility in the medical world.  It is called change tracking and it is the ability for the healthcare professional reading the portable medical record to look at what changes have been made in the portable medical record and what existed in the record before the change was made.  Change tracking is an internal audit of the system and ensures that there has been no tampering that could threaten a patient's life.

At least there was not such a system until this week.  This week www.theoriginalmymedicalrecords.com announced the prototype release of Version 1.2, a portable medical record with change tracking, high-level encryption and password protection.

This is truly something new and represents a second generation of portable medical record.

Where will this new medical device find a home? 

As the water resistant or splash resistant USB devices these units are already finding a home on the wrists of scuba divers, sky divers, mountain bikers and others who enjoy high fun/ high risk sports.
      
But I envision a larger market.  I envision a day when rather than receiving a flimsy paper wristband at the hospital or nursing home a patient has a portable medical record in a waterproof band around their wrist.  When the nurse comes by with their wireless Tablet computer to chart she simply plugs the patient record band in and the records are immediately synchronized.  The patient goes nowhere without their chart on their wrist.
      
When they go home the patient takes the band with them carrying the entire chart in miniature form.  The hospital has its copy.  The patient has their copy and their copy goes back to the doctor's office.
      
In the event of an emergency the patient's band is on their wrist and it does not matter what emergency room they go into, what EMS service picks them up all the important information is at the fingertips of those there to save their life.
      
I envision a day when my disaster medical assistance team (MDMS/DMAT-FL3) provides care in a Katrina like event after a natural disaster with subsequent flooding and places a USB flash drive wristband around the wrist of every evacuee.  Information on federal assistance, registration for finding lost family members, their own personal information as well as a health record will travel with them from the moment of rescue until their final destination.  If they already had a personal medical record on their wrist or in their pocket or around their neck as an independent we in the MDMS/DMAT-FL3 would be able to plug their device into our computers and upload the important information to help them recover their lives and help us treat their injuries.
      
This second generation of flash drive device holds tremendous promise not only for the transfer of information but even the prevention of medical errors by ensuring that the most basic information is in the hands of those who are making the most important decisions.

An Innovative Approach to Disaster Preparedness

I have been in the disaster response field for over 20 years and had thought I had seen or at least imagined every possible means of reaching the general public. We have had a "War on Terror," a disaster evacuation back packs sold on infomercials, catalog and Internet sales of every size, shape and description of preparedness tool and resource. Today I was introduced to a new and definitely different approach to the problem of getting the everyday person to be prepared, a multi-level marketing business (MLM).

Don;t worry gentle readers, I am not in the MLM business and there is no pitch coming.

MLM's have been around for over half a century. These highly regulated companies present everything from vitamins and supplements to industrial cleaning supplies,to information systems for MLM marketers. In my remote past, I was a motivational speaker for three different MLM companies, but I never thought I would see an MLM dedicated to disaster preparation products.

My introduction to the concept came as most MLM introductions do, by email from a colleague. She is an "independent representative" (the legal term is "independent distributor") and felt I establish a "business" through my network of disaster professionals, family and audiences. I will admit that the product line appears both reputable and useful. The marketing system will reach a lot of people and most that sign-up for MLM's do so for the networking, not the products so it will be a group otherwise unresponsive to the preparedness message.

The old adage: "There's nothing new under the sun," may be true, but there is always a new use for an old tool.

Special Report on Implications of NIMS Integration Plan for Hospitals and Healthcare

The arrival of 2007 brings with it the mandate for Hospital and Healthcare preparedness that so many of us have sought for many years now. Many hospitals and healthcare institutions have not yet discovered the regulatory maneuvering that occurred throughout 2006 to create this new atmosphere. In essence, government and private regulatory agencies have created a situation in which failure to prepare will no longer be tolerated and those who persist in their unpreparedness suffer significant financial penalties.

Introduction:

The Homeland Security Act of 2002 provided the authority for the creation of the Department of Homeland Security (DHS).  It also directed the Director of DHS to create a National Incident Management System (NIMS).  Published in 2004, NIMS formed the framework for detection, mitigation, response and recovery from man-made and natural occurring disasters, events and incidents of national significance within the United States, its territories, protectorates and Indian Tribal nations.  NIMS provided the framework for the creation of the National Response Plan (NRP), also published in 2004.  The National Response Plan is an all-hazards, all-agencies approach to the detection, mitigation, response and recovery from disasters, whether natural or man-made events and incidents of national significance.   A little known provision of NIMS created a classification system for all disaster-related resources.  This classification system, the National Resource Typing System (NRTS) provides a unified cross-agency, cross-jurisdictional means of classifying all resources that are or could be used in response to a NRP/NIMS event, whether these resources are equipment or personnel. 

Responsibilities of a Signatory:

All federal agencies, all 50 states, all U.S. protectorates and territories and all Tribal Nations within the scope and authority of the federal government have now become signatories to NRP/NIMS.  Among these signatories are the Health Resource and Services Administration (HRSA) and the Department of Health and Human Services (DHHS), the parent agency for Medicare, Medicaid and Veteran Healthcare funding. This signatory status places certain responsibilities upon these agencies and governments, as well as providing them certain rights and privileges. These rights and responsibilities are incumbent upon all agencies that derive their funding or authority from a signatory to NRP/NIMS.

In addition to an irrevocable agreement to participate fully in any disaster, whether man-made or natural, event or incident of national significance within the region of that signatory or the authority of that signatory’s office, department or agency, all signatories to the NIMS/NRP have pre-agreed to all changes, classifications, modifications and regulations that may be promulgated by the director of DHS or the NIMS Integration Center or the NRP Implementation Center. Such changes, classifications, modifications and regulations must be implemented without modification.

NIMS Requirements Upon DHS of Significance:

Within NIMS, there are several clauses that are of significance to establishing a new industry in the area of Disaster Preparedness, Planning, Training and Evaluation within the United States. Recurrent through the document is the phrase “establish qualifications, credentials and certification for hospitals and healthcare facilities in cooperation with … and national professional organizations”.  This phrase appears in every reference to hospitals and healthcare facilities in all levels of the response – administrative, financial, logistical and most notably operational.  When hospitals are specifically noted, this phrase occurs with increased regularity.  To date, there has been no classification, credentialing or certification system implemented by the DHS, NIMS, or NRP.  The NRTS provides no guidance, as of the writing of this report, for the qualification, certification, credentialing, or typing of medical providers and, more specifically, physicians.  However, the NIMS Integration Center, on September 12, 2006, quietly published a Hospital and Healthcare Facility NIMS Implementation Plan.

NIMS Responsibility Upon DHHS of Significance:

In addition to an irrevocable agreement to participate fully in any disaster, whether man-made or natural, event or incident of national significance within the region of that signatory or the authority of that signatory’s office, department or agency, all signatories to the NIMS/NRP have pre-agreed to all changes, classifications, modifications and regulations that may be promulgated by the director of DHS or the NIMS Integration Center or the NRP Implementation Center. Such changes, classifications, modifications and regulations must be implemented without modification.

The Center for Medical Services (CMS) is the DHHS agency specifically empowered and charged with the responsibility of overseeing all operations for Medicare, Medicaid and Tricare. These responsibilities include the certification of participating Hospitals and Healthcare facilities whether directly through a network of Regional Offices (RO’s) and State Agencies (SA’s) or through approved private organizations including the Joint Commission for Accreditation of Healthcare Organizations (JCAHO) and the Healthcare Facility Accreditation Program (HFAP) of the American Osteopathic Association (AOA). CMS draws its authority directly from the secretary of DHHS and is responsible for performing all the duties and responsibilities of the secretary of DHHS as applied to Medicare, Medicaid and Tricare, including but not limited to promulgating regulations and regulatory guidance towards this end.

NIMS Implementation Center Hospital and Healthcare Facility Plan:

The NIMS Implementation Center Hospital and Healthcare Facility Plan provides a new landscape for those providing Disaster Planning, Preparedness, Training and Evaluation services as well as for national organizations involved in the certification or accreditation of healthcare facilities, healthcare professionals, planning professionals and emergency management professionals.

JCAHO Accreditation Standards and Disaster Preparedness:

The Joint Commission for Accreditation of Healthcare Organizations (JCAHO) has become the de facto standard for hospital and healthcare facility accreditation. The American Osteopathic Association (AOA) has a parallel Healthcare Facility Accreditation Program (HFAP). For the purposes of this discussion, there is no practical difference in the standards set forth by JCAHO and AOA. As JCAHO is the more common accreditation, the discussion will center on the JCAHO standards.

Participating hospitals and healthcare facilities renounce “self-certification” in favor of external accreditation by JCAHO. The DHHS through CMS uses JCAHO accreditation in lieu of CMS certification for the purposes of CMS provider eligibility. Loss of JCAHO accreditation is synonymous with loss of CMS provider eligibility. JCAHO published a special compliance manual entitled Standing Together which outlines the JCAHO standards for disaster preparedness in the post-9/11 era and provides guidance on meeting these standards.

The JCAHO standards have specifically adopted the START/JumpSTART Disaster Triage System (aka Integrated Triage). JCAHO guidance also specifically addresses Disaster Preparedness and Training through Immersion Simulation Drills, referred to as “community wide” and “influx drills.” The JCAHO guidance allows tabletop exercises, but this type of drill does not fulfill the need for influx drills. JCAHO specifies that an accredited hospital must conduct at least one community wide drill every year and at least two influx drills every two years.

Center for Medical Services (CMS):

The Department of Health and Human Services (DHHS), a signatory to NRP/NIMS is the supervisory agency for Medicare, Medicaid and Tricare (Veteran’s Administration) funding through the Center for Medical Services (CMS). The regulatory agency provides certification for hospitals and other healthcare facilities either through JCAHO/HFAP or directly though its own system of state inspection offices/teams. CMS regulations carry the force of federal law under various aspects of the Social Security Act Title XVIII and XIV. The specific Federal Register sections applicable to this discussion include 42CFR482.1 and its applicable regulatory guidance. The CMS State Operations Manual provides the clearest guidance on the current interpretation of 42CFR482.1 and CMS regulations. CMS provides for both enforcement of these safety and preparedness regulations.

As an office of a NRP/NIMS signatory agency, it is incumbent on CMS to comply with the full implementation of NRP/NIMS. This compliance includes requiring NRP/NIMS compliance of all vendors (Hospitals and Healthcare Facilities) receiving funding through CMS. CMS regulations create a regulatory requirement for full NRP/NIMS compliance by all Medicare, Medicaid and Tricare certified Hospitals and Healthcare facilities. As an office of a NRP/NIMS signatory (DHHS) these requirements are no more than a restatement of NIMS and the NIMS Implementation Center Hospital and Healthcare Facility Plan. Further, CMS has elevated non-compliance with safety and preparedness to the level of an “immediate jeopardy” and thus immediate suspension of a hospital or healthcare facility’s status as a CMS (Medicare, Medicaid & Tricare) participating provider.

Correlation of the NIMS-IC Plan, CMS Regulations & JCAHO Standards:

Correlation 1:
The NRP/NIMS signatory agreement signed by DHHS and thus incumbent upon CMS to implement combined with the applicable policies, regulations and accreditation requirements of CMS, HRSA and JCAHO create a mandate for full and unmodified compliance with NRP/NIMS/NRTS and the NIMS Implementation Center Hospital and Healthcare Facility Plan is incumbent upon all hospitals and healthcare facilities.

Correlation 2:
CMS regulations and JCAHO standards both call for the use of an Incident Command structure and attention to the four phases of disaster. This paraphrases the NIMS Implementation Center Hospital and Healthcare Facility Plan requirements for the use of the Incident Command System structure and ICS education.

Correlation 3:
CMS regulations and JCAHO standards require hospitals and healthcare facilities cooperate with community based multi-agency responses to disaster as well as participating in community wide multi-agency drills. This parallels the NIMS Implementation Center Hospital and Healthcare Facility Plan and effectively implements this portion of this plan.

Correlation 4:
The combination of the CMS use of JCAHO accreditation as CMS certification and the deferment of certification by hospitals to JCAHO makes JCAHO accreditation the de facto certification to fulfill the NIMS Implementation Center mandate for “self-certification.” Thus JCAHO accreditation also has become the de facto certification of compliance with the NIMS Implementation Center Hospital and Healthcare Facility Plan for each individual Hospital or Healthcare Facility.

Correlation 5:
CMS regulations and JCAHO standards prescribe that an accredited hospital or healthcare facility must develop and publish for CMS/JCAHO review an operational budget including the provision of capital for all aspects of business operation. This echoes the NIMS Implementation Center Hospital and Healthcare Facility Plan provisions regarding Preparedness Funding.

Correlation 6:
CMS regulations and JCAHO standards require revision of existing plans as well as regular updating of plans in light of both pre-event Vulnerability Analysis and Post Event Review (After Action Review). These clauses validate the NRP/NIMS and NIMS Implementation Center Hospital and Healthcare Facility Plan requirements for plan revision and regular reevaluation.

Correlation 7:
CMS regulations and JCAHO standards detail requirements for both Community Wide and Surge (Influx) disaster drills. Further, both organizations discourage Tabletop Exercises in favor of Live Patient and Simulator Environment Drills. The detailed and recurrent reference to these drills emphasizes the weight and importance placed on this phase by these regulatory and accrediting agencies. This emphasis reflects the same importance given to disaster drills by NRP/NIMS and NIMS Implementation Center Hospital and Healthcare Facility Plan.

Correlation 8:
CMS regulations and JCAHO standards specify that hospitals and healthcare facilities must maintain sufficient supplies and resources including generators, potable water, medications and oxygen to ensure the safety of all staff, patients and residents. These requirements are included in multiple key sections of the regulations including Life Safety, Facility Operations, Patient Safety and Human Resources/Personnel. The JCAHO and CMS sections are actually more stringent and specific than the comparable NIMS Implementation Center Hospital and Healthcare Facility Plan portions.

Correlation 9:
CMS regulations and JCAHO standards specify the use of plain English and a common nomenclature in all communications without allowance for a different language or nomenclature in event of disaster. This common language requirement is far more stringently worded than the associated NIMS Implementation Center Hospital and Healthcare Facility Plan sections in large part owing to the high priority placed by both CMS and JCAHO on the 1999 To Err is Human report published by the Institute of Medicine.

Implication of the NIMS-IC Plan, CMS Regulations & JCAHO Standards:

Implication 1:
Whether by design or serendipity, recently published CMS regulatory changes and progressive refinement of JCAHO standards have resulted in accreditation criteria that now closely approximate those put forth in NRP/NIMS and the NIMS Implementation Center Hospital and Healthcare Facility Plan. This has the effect of creating a regulatory mandate for hospitals and healthcare facilities to fully implement NRP/NIMS and the NIMS Implementation Center Hospital and Healthcare Facility Plan. It is the position of High Alert that this creates a new market for Disaster Planning Services and Disaster Preparedness, Response & Recovery Education.

Implication 2:
Owing largely to the Nationals Patient Safety Program initiated by JCAHO and CMS in response to the Institutes of Medicine To Err is Human report, recently published CMS regulatory changes and progressive refinement of JCAHO standards have resulted in accreditation criteria for resource acquisition/inventory and common communication nomenclature that exceed those put forth in NRP/NIMS and the NIMS Implementation Center Hospital and Healthcare Facility Plan. Further, both agencies have tied these criteria to the facility safety/Life Safety criteria for accreditation.

Implication 3:
Following the catastrophic events of the 2004 and 2005 hurricane season and the recent National Academies of Science reports regarding Hospital and Community Disaster Preparedness, recently published CMS regulatory changes and progressive refinement of JCAHO standards have resulted in accreditation criteria for disaster planning, education and drills that exceed those put forth in NRP/NIMS and the NIMS Implementation Center Hospital and Healthcare Facility Plan. Further, both agencies have tied these criteria to the facility safety/Life Safety criteria for accreditation.

Implication 4:
Because certification by CMS and indirectly JCAHO accreditation are required for Medicare, Medicaid and Tricare insurance participation and because CMS and JCAHO have tied much of their disaster preparedness criteria to the facility safety and Life Safety certification criteria, violation of these criteria would immediately suspend CMS certification and thus immediately suspend Medicare, Medicaid and Tricare insurance participation by the violating hospital or healthcare facility. Further, all private insurance suspends program participation in the event o a CMS suspension. Thus violation of the CMS and/or JCAHO disaster preparedness criteria and by extension the NIMS Implementation Center Hospital and Healthcare Facility Plan holds significant financial penalties for any hospital or healthcare facility.

Conclusion:

Based on the comprehensive review of CMS regulations, JCAHO standards, NRP/NIMS and the NIMS Implementation Center Hospital and Healthcare Facility Plan, it is the position of High Alert that this creates a market pressure towards Comprehensive Immersion Simulation Training that includes a “Crawl – Walk – Run” Disaster Exercise program for staff and ICS training for administration. This program can be delivered in 5 to 6 days and provide all required education and drills to meet all patient safety, disaster preparedness/response and community/multi-agency drills required under CMS regulations, JCAHO standards, NRP/NIMS and the NIMS Implementation Center Hospital and Healthcare Facility Plan. Such a program provide client hospitals and healthcare facilities with comprehensive disaster planning, preparation and response training, significant patient safety improvement through the use of simulation based training and demonstrable cost savings compared to the present market approach to these processes while protecting these clients from potential financial harm.

The fortuitous conflagration of CMS regulations, JCAHO standards, NRP/NIMS/NIMS Implementation Center Hospital and Healthcare Facility Plan revisions, National Academies of Sciences Reports on Hospital and Community Preparedness and the Institutes of Medicine To Err is Human report create an unexpected environment that yields de facto mandates for full and unmodified implementation of the NIMS Implementation Center Hospital and Healthcare Facility Plan. Further the market is ripe for the introduction of the next evolution disaster preparedness training.

Immersion Simulation Training will extend the disaster training to the inpatient bedside environment and include high fidelity human patient simulators to train not only disaster and terrorism response/treatment, but also patient safety and other issues raised in the Institute of Medicine report To Err is Human. This model creates a training environment akin to that used to train airline pilots and fighter pilots. Teams trained in this model we employ techniques patterned after those used to train NASCAR Pit Crews to work quickly and accurately in a high risk, high stress and fast paced environment.