A Critical Quality Consideration – Which Oncology Clinical Certifications Matter?

Promoting Quality to Improve Outcomes and Cut Costs

Which Oncology Clinical Certifications Matter?

By Wes Chapman

May 23, 2013

Summary

Professional medical societies have certification programs which certify the medical practices at certain locations as being “certified” for practicing the highest standard of care. These certifications are provided by a variety of medical societies in oncology including: 1)  American College of Surgeons Commission on Cancer (ACS CoC), 2)  American Society of Clinical Oncologists (ASCO), 3) American College of Radiologists, 4) American College of Radiation Oncologists, and 5) American Society for Radiation Oncology. We have seen these certifications increasingly used to determine the potential for participation in quality based incentive plans, and have taken a systematic look at how they compare based on a series of objective quality criteria. We rated and ranked the certifications based on a scale of 1 (low score is best) to 5, and then compiled the totals into a ranking of 1-5 stars, based on a scale graded between 10 – the lowest possible score and 50.

 

On this basis CoC and QOPI both received 5 stars, with scores of 14 and 20 respectively. Both ACR and ACRO received scores of 4 stars, with respective scores of 26 and 23. While ASTRO holds much promise for its certification program, it is still in formation, but it still received 3 stars based on the work done to date.

The Solution for Payers: Promote Quality Certification

Private health insurance companies are in a unique position to speed the acceptance and reach of quality certifications by promoting their use within their provider networks. This is particularly important in oncology, where outcome data is difficult to assemble and interpret.

Some of the largest payer organizations in the U.S. – including Aetna, BCBS, Humana, and United – have already endorsed the Quality Oncology Practice Initiative Certification Program (QOPI) of the American Society of Clinical Oncology (ASCO). We have seen certifications of clinical programs at provider sites used by payers in evaluating provider organizations for participation in new alignment structures including private ACOs. Based on payer reliance on these certification programs, we have undertaken a systematic look at how they differ and their potential value in the evaluation of clinical care.

Which Standards Are Worth It?

The certification bodies considered in this paper are non-profit oncology specialty societies that focus on education for their members, along with research into evidence-based treatment guidelines. The criteria were selected as representative of best practices in quality systems in general, and medical quality systems in particular. Criteria for the institution:

  • Quality/certification a key component of mission statement
  • Specialty area expertise, including education and research
  • Large membership with national reach
  • Solid reputation; respected in the medical community
  • Non-profit and non-lobbying

Criteria for the standards:

  • Wide-ranging within the specialty, covering many aspects of care
  • Evidence-based
  • Include clinical pathways
  • Updated frequently

Criteria for the certification process

  • Audited frequently; annually is preferred
  • Requires documented and timely response to nonconformities
  • Encourages continuous improvement
  • Transparent; requires public reporting of patient outcomes

Oncology Certification Programs to Consider

To date, no certification program for oncology meets our full list of criteria; however, they serve as guidelines for choosing from what is currently available, and for determining how those programs can be improved. The table that begins on the next page allows a comparison of the major certification programs in oncology. An analysis following the table points out the shortcomings and advantages of each certification program and rates them on a scale of 1 to 5.

The table compares these oncology certification programs:

  • CoC: From the American College of Surgeons Commission on Cancer (ACS CoC)
  • QOPI: From the American Society of Clinical Oncologists (ASCO)
  • ACR: From the American College of Radiologists (ACR)
  • ACRO: From the American College of Radiation Oncologists
  • ASTRO: From the American Society for Radiation Oncology

Note that, for a number of years, ASTRO and ACR jointly certified radiation oncologists through the ACR program. In October of 2012, ASTRO withdrew from the partnership in order to create its own certification program. The ASTRO standards are still in development.

Snip 1Snip 2Snip 3Snip 4

Analysis of the Table

American College of Surgeons Commission on Cancer (CoC) Accreditation

CoC Accreditation with commendation: Score = 14

Shortcomings

  • Does not require public reporting of outcomes to the general public - except with commendation.
  • Evidence-based measures are highly-specific and by no means comprehensive. The CoC has a distinct advantage with its huge database of cancer cases, the NCDB, so it is hard to believe that they can put together a more comprehensive set of quality measures.
  • Their definition of “continuous improvement” is somewhat arbitrary, but CoC requires its awardees to execute at least two continuous improvement efforts every year.
  • Several safety measures are outsourced. In the case of radiation oncology, this is commendable, because other organizations hold much more expertise in these areas. Inclusion of evidence-based processes would be desirable.
  • No public reporting of outcomes.

Advantages

  • Strict requirements for Cancer Program Practice Profile Reports (CP3R) measure performance.
  • Data quality requirements, beyond chart abstractions.
  • Data requirements for diagnostic purposes and treatment planning.
  • Requires a multi-specialty tumor board. This tumor board leads the different programs required by accreditation, including prevention, screening, and continuous improvement programs.

QOPI: Score = 20

Shortcomings

  • Data quality requirements are more loose than most, with an audit upon achieving accreditation / reaccreditation, but doesn’t necessarily audit participants every year
  • Data auditing requires chart abstraction is cumbersome and expensive In a world where electronic medical record systems are common, other forms of reporting could be accepted.
  • Could benefit from including data quality requirements.
  • No public reporting of outcomes

Advantages

  • QOPI has strict performance and quality-of-care requirements.
  • Has a well-defined set of safety measures in a separate standard, to ensure safe patient care.
  • Well-respected, comprehensive set of evidence-based quality measures.
  • QOPI raises the bar for cancer center performance—in 2011, performance required by QOPI was 72.62% and today it is 75%—instead of leaving it up to each individual cancer center.

ACR: Score = 26

Shortcomings

  • Clinical pathways and processes are not specified.
  • Safety standards are loosely-defined when compared against ACRO.
  • Does not include a lower-bound on minimum acceptable process improvement.
  • Neither public reporting nor collection of outcomes data.
  • Could benefit from including data quality requirements.
  • Not entirely clear about what or how they will measure performance. They do not state how or why they will score different charts.

Advantages

  • ACR’s guidelines can do tremendous good.
  • Requires compliance to safety guidelines established by ACR and ASTRO.

ACRO: Score = 23

Shortcomings

  • Does not require public reporting of outcomes data.
  • Could benefit from including data quality requirements.
  • Does not necessarily include evidence-based guidelines; charts are reviewed with an eye towards NCCN’s evidence-based pathways.

Advantages

  • Establishes a process-based approach and defines an evidence-based process for delivering safe radiation oncology therapy.
  • Comprehensive set of safety requirements that include processes, staffing, and other areas relevant to clinical quality.
  • Process-based continuous improvement requirement.
  • Very clear regarding requirements and criteria for chart reviews.
  • Reminiscent of an ISO 9001 quality management system, but adapted for a radiation oncology clinic.

ASTRO: Score = 33

Shortcomings

  • Not fully completed yet.
  • It is unclear whether continuous improvement will be a requirement.

Advantages

  • Will include a very comprehensive set of safety measures, perhaps the most comprehensive of any accreditation.
  • Will include public reporting of outcomes data, the first radiation oncology certification to require this.
  • Performance standards will derive from evidence-based guidelines.

 

Quality Rankings Tabular Analysis

Snip 5

Rating the Certifications

We have rated the certifications on a scale of 1 to 5 and also make recommendations for their areas of application. (Obviously, a provider that doesn’t perform radiation therapy or diagnostics should not be expected to have certification in that area.)

ACRO: 4 Stars – Recommended for radiation oncology clinics and cancer centers that offer radiation therapy.

CoC with commendation: 5 Stars – Recommended for cancer centers.

QOPI: 4 Stars – Recommended for medical oncology clinics and cancer centers.

CoC (without commendation): NR – We recommend CoC with commendation first, or else CoC combined with QOPI.

ACR: 4 Stars – We recommend ACRO first, but would recommend ACR over nothing at all.

ASTRO: 3 Stars – – This seems to be a promising, comprehensive certification, but we must defer a recommendation until the standard is published.

Note that any of these certifications is preferable to no quality certifications at all. In the case of certifications not listed here, payers can use the criteria and table headings to compare and rate them before deciding whether to promote them among their network providers.

Conclusion

All of the certifications reviewed offer worthwhile measures for medical practice, and are increasingly moving in the direction of the best quality management systems – like ISO 9001 – requiring best practice adherence, continuous improvement and outcome analysis to test effectiveness. Clearly data access and quality loom as major issues for all medical quality systems, and the gigantic investment in EMRs has not yet facilitated real time access to meaningful data sufficient to power any of the certifications.

CMS & ISO 9001 – The Impulse Toward Quality in Healthcare

CMS and ISO 9001

The Impulse Toward Quality in Healthcare

By Wes Chapman, Steve Maker, and Mario Martinez • April, 2013

Preface

This is the first of two white papers on ISO 9001 in healthcare. This paper provides a historical perspective, an overview of the purpose and principles of ISO 9001, and a brief look at the potential of ISO 9001 to transform healthcare delivery in the U.S. now that accreditation and certification under its standards have been embraced by CMS. The second paper will take a closer look at the process required to successfully implement ISO 9001.

Background

In 2008, a revolution started in healthcare quality – ISO 9001:2008 entered the fray when the Centers for Medicare and Medicaid Services (CMS) approved Det Norske Veritas (DNV) as a deeming authority for Medicare payments. DNV was the first new deeming authority named by CMS in over 40 years, and ISO 9001 – considered the gold standard for quality improvement systems – played a key role in the decision. DNV had just completed development of a system it calls the National Integrated Accreditation of Healthcare Organizations (NIAHO), which it will use to accredit hospitals under CMS’ Conditions of Participation (CoPs). NIAHO combines the CoPs standards with the ISO 9001:2008 quality standards developed by the International Organization for Standardization (ISO). Healthcare providers must meet the CoPs quality and safety standards in order to be reimbursed for treating patients under Medicare and Medicaid; in 2008, ISO 9001 became the best system available to achieve that accreditation and maintain the standards necessary to keep it.

Quality improvement, along with cost reduction and payment reform, has been an elusive goal in the complex environment of healthcare delivery. Traditional quality tools like Lean and Six Sigma have proven difficult to adapt from their roots in straightforward process environments such as auto manufacturing. ISO 9001 provides the overarching management structure needed to incorporate these types of tools into a more encompassing quality management system suited to healthcare organizations. ISO 9001 is designed for service providers as well as manufacturers. ISO 9001 is focused on customer requirements and satisfaction, and there is certainly no industry that should be more customer-focused than healthcare. ISO 9001 is flexible, allowing each healthcare provider to develop and implement a quality management system appropriate to its structure, methods, and organizational culture. And ISO 9001 requires continuous improvement in order to remain certified, which means continuous benefit to the healthcare provider, to CMS, and to the patients.

The Deeming Authorities

Several other organizations have deeming authority from CMS (see the table, below), but one in particular – the Joint Commission (TJC, formerly JCAHO) – has handled the majority of hospital applicants in the 40 years since Medicare was created. In fact, TJC was the only deeming authority named in the initial law. Until very recently, TJC had not incorporated ISO 9001 into its accreditation process, nor had it offered ISO 9001 certification separately. DNV does offer full certification under ISO 9001 in addition to CoPs accreditation under NIAHO. By granting deeming authority to DNV, CMS (which is itself ISO 9001 certified) seems to have signaled its determination to control rising health care costs in the U.S. without reducing the quality of care. In fact, this is almost a standing order to hospitals to improve care without backsliding.

Accreditation Organizations with   CMS Deeming Authority
Accreditor Scope of Authority # of accredited customers (CoPs) ISO connection
The Joint Commission Hospitals, Labs, Durable Medical Equipment, Home   Health, Hospice, other Around 5,000 hospitals and over 10,000 other   institutions Affiliated with SGS to offer the option of ISO   certification to members
DNV Healthcare Critical Access Hospitals (CAH), Acute Care Hospitals   (ACH) Around 300 hospitals (over 1200 though DNV   international groups) Requires ISO 9001 certification within two years
American Osteopathic Association (HFAP) CAH, ACH, Ambulatory Surgical Center, Behavioral   Health, Lab Around 230 hospitals and 200 other institutions No ISO relationship
ACHC Home Health, Hospice, Durable Medical Equipment   (DMEPOS) No hospitals, 8,700 DMEPOS, 1,400 Home Health, and 300   Hospices ISO-certified itself but not offering ISO certification   to clients

TJC has seen the opportunity and responded. In 2011, it announced an agreement with the Geneva-based ISO registrar SGS Group to offer ISO 9001 certification, in addition to CoPs and the other accreditations it offers. Due to its organizational roots and long affiliation with CMS, TJC can claim over 20,000 U.S. clients, of which over half are hospitals or home care organizations, though TJC/SGS has yet to announce any ISO 9001 clients. Depending on the source, DNV is working with somewhere between 250 and 300 clients in the U.S., for both CoPs accreditation under NIAHO and ISO certification. Globally, they have certified over 1200 healthcare organizations under ISO 9001 to date.

It’s very hard to estimate how many U.S. hospitals have achieved ISO 9001 certification already. In addition to DNV’s 300 or so clients working toward that end, a few healthcare organizations have already achieved it through other means. Two of them – Physician’ Clinic of Iowa (PCI) and the Office of Medical Services (MED) of the U.S. Department of State – are well documented in the book Using ISO 9001 in Healthcare (Levett and Burney, ASQ Quality Press, 2011). As the public becomes more concerned about quality and more aware of the high standard indicated by ISO 9001, we can expect to see more and more certification logos on hospital web sites and letterhead, and with them, higher quality throughout the healthcare system.

Introducing ISO and ISO 9001

“ISO is just quality on steroids.”
(Director of the QMS in a 700-bed hospital working with DNV Healthcare)

ISO can refer to the International Organization for Standardization or to the standards it produces. The organization has its roots in mechanical engineering. It was founded as the International Federation of the National Standardizing Associations in 1926, disbanded in 1942, and reformed under the current name in 1946, after the dust from World War II had settled. Then and now it was an international organization made up of its member nations’ standards organizations (the U.S. representative being the American National Standards Institute, or ANSI), and its sole purpose is to develop standards for an expanding variety of industries. In addition to standards, it publishes technical reports, specifications, and related documents, most of which are developed by a network of 2,700 committees, subcommittees, and working groups.

ISO 9001 began life in 1959 in the form of a quality/inspection-based standard for the U.S. Defense Department. With much revision and expansion, it became an ISO standard in 1979. In 1987, a new revision emerged as ISO 9000, which continued to evolve, being republished in 2000 as a management system standard suitable for both manufacturing and service industries. ISO 9000 specifies the fundamentals and vocabulary underpinning ISO 9001, a quality system standard, which evolved in parallel with ISO 9000. The latest revision is ISO 9001:2008.

ISO 9001 is a respected and widely accepted framework already used to improve quality, improve value delivered to customers, and reduce costs by:

  • CMS, which is rated as the most effective healthcare payer in the U.S.
  • The American Society for Quality (ASQ)
  • The automotive industry, which has continually and dramatically improved quality over the past 50 years in its race with Japanese and German manufacturers
  • The aeronautics industry, where good quality controls have made aircraft safer and where bad quality controls produced the Dreamliner
  • Manufacturing in general
  • Franchises, which use ISO 9001 to replicate operational improvements
  • Multinationals, which use ISO to replicate their successes, while still allowing for flexibility across different regions
  • And now healthcare

What is ISO 9001?

ISO 9001 is often referred to as a quality system, but technically it is not. As stated above, it is a quality system standard. It has also been described as a meta-management system. This is a fine point to argue, but keeping it mind can help avoid confusion over what ISO 9001 offers.

ISO 9001 does not describe a specific quality tool, like Lean or Six Sigma. Instead, it specifies the types of components a quality system must have in order to improve processes and increase value. For example, one of its requirements it to create a Quality Manual, but it does not provide a rigid outline or table of contents. Instead, it states eight principles that underlie effective quality management and then defines the processes required to incorporate those principles into a quality management system. ISO 9001 leaves it up to each organization to develop the Quality Manual that is most appropriate to its own operations. It is not a how-to book; it shows you how to write your own how-to book.

The eight principles in ISO 9001 are:

  • Customer focus
  • Leadership
  • Involvement of people
  • Process approach
  • System approach to management
  • Continual improvement
  • Factual approach to decision making
  • Mutually beneficial supplier relationships

Customer Focus refers to patients, of course, but also to their families and all the other stakeholders involved in healthcare delivery. That includes outside providers to whom you refer patients, payers, vendors, and your own staff. Each of these groups has its own set of (sometimes conflicting) expectations and needs. ISO 9001 makes customer focus the first requirement under Management Responsibility:

Top management shall ensure that customer requirements are determined and are met with the aim of enhancing customer satisfaction. (Section 5.2, page 4, ISO 9001:2008(E))

Note that the standard specifies determining the customers’ requirements and also, by implication, determining if they were satisfied by the services they received. The exact methods used to discover and document this information are left to the quality team to define.

Leadership refers to a firm commitment from management to adopt the ISO 9001 standard for quality improvement. The principles and processes described provide a framework for the quality system, but the strategy, objectives, and leadership role models must come from within the organization.

Involvement of people means just that: Everyone in the organization needs to be involved in developing the quality system and making it work. This requires another commitment from management: to provide training and resources. In the complex network of processes that is healthcare delivery, it’s also important to ask and to listen to employees at every level in every department, not only because they will have information you need to know, but also so they realize the important part they play in the development, implementation, and ongoing improvement of the quality system.

The Process Approach applies to the processes of healthcare – from clinical pathways to housekeeping to buildings and grounds – and to the processes of administration and quality management. Every key process will need to be defined and managed.

A Systems Approach to Management means viewing the entire operation as a system of interrelated processes. Knowing how the processes flow and understanding how they interact to achieve specified objectives allows managers to improve effectiveness throughout the organization.

Continual Improvement is a key component in the standards. Many quality tools provide a method to improve processes, but don’t provide a system for maintaining that level of quality over time. Throughout the quality process, ISO 9001 does a very good job of asking questions and then forcing you to not only write down the answers but also follow up on delivery. This drives the process of continual improvement.

A Factual Approach to Decision Making could be stated simply as monitor, measure, and document, but ISO 9001 goes farther, to require documentation at almost every step in the quality process. At its core, a dedication to fact-based decision making means the use of impartial and auditable data. It begins with the definition of the processes in your operations and in your quality management systems, because “you can’t control a process you can’t describe.” Documentation continues throughout the implementation of your quality management system, and afterward as you monitor the daily workings of your healthcare delivery system. Documentation continues as you identify what works well and what falls short, allowing you to analyze how to adopt strengths as standard operating procedures (SOPs), and to find solutions for problems that arise in the future. Documentation still continues as you monitor the results of your solutions to guarantee they are implemented as designed and that they work.

Mutually Beneficial Supplier Relationships includes treating each other as customers, learning each other’s requirements, and verifying that both sides are satisfied with the results. In an ISO-based system, suppliers are valued partners, with the inescapable reality of shared success. Quality is not a zero sum game. ISO 9001 also requires a process in your quality system to insure that your suppliers are working at the same level of quality you are, hopefully with their own IS0 9001 certification.

Nuts and Bolts

Each of eight principles applies to the entire quality process, and they are referred to throughout the ISO 9001 document. After three brief chapters that describe the document’s scope, normative references, and terms and definitions, the document’s table of contents covers:

4)      Quality management system

5)      Management responsibility

6)      Resource management

7)      Product/Service realization

8)      Measurement, analysis and improvement

To quote from ISO’s website, the standard:

…covers all aspects of an organization’s activities, including; identifying its key processes, defining roles and responsibilities, policies and objectives, documentation requirements, the importance of understanding and meeting customer requirements, communication, resource requirements, training, product and process planning, design processes, purchasing, production and service, monitoring and measurement of products and processes, customer satisfaction, internal audit, management review, and improvement processes.

                       ISO SYstem Diagram

The second white paper will go into these processes in more detail. It’s important to realize, however, that ISO 9001 doesn’t expect you to reinvent the quality management wheel. In fact, it assumes organizations will use the standard in conjunction with other quality management tools. In our 2011 white paper, Medical Quality Systems: The Elusive Goal of Quality in Complex Systems (http://pcdsys.com/medical-quality-systems-the-elusive-goal-of-quality-in-complex-medical-systems/), we outline a system that we believe to be very effective in the complex environment of healthcare delivery. This system combines ISO 9001 with checklists and elements of the Lean and Six Sigma quality toolsets (commonly referred to jointly as “LSS”).

ISO 9001 can easily incorporate medical standards, not only those in CoPs but also clinical guidelines. We have written earlier about the importance of defining and adhering to best practice customer-related processes (i.e., clinical pathways and metrics: see A Taxonomy of Leading Oncology Organizations, http://pcdsys.com/taxonomy-of-leading-oncology-organizations/) and of using patient-reported outcomes (PROs: see Choosing Appropriate Metrics From a Still-Evolving Toolset, http://pcdsys.com/patient-reported-outcomes-choosing-appropriate-metrics-from-a-still-evolving-toolset/). In our most recent white paper, we discuss the importance of patient education and shared decision-making (Palliative Medicine and Patient Involvement: The Heart of Patient-Centric Care, http://pcdsys.com/palliative-medicine-and-patient-involvement-the-heart-of-patient-centric-care/). ISO 9001 goes beyond endorsing practices like these as key tools for managing and improving the quality of your healthcare delivery system – it requires them.

Properly implemented, ISO 9001 guarantees that the other tools are being used correctly and are being continually monitored to identify existing weak points that should be corrected, and to catch new problems that creep in over time. ISO 9001 will keep the system working well and improve it over time.

What Can Go Wrong with ISO 9001?

One stumbling block for healthcare providers when they first encounter ISO 9001 is the language used. There are no healthcare-specific terms. That is actually a benefit of the standard: It is flexible across and within industries. As you define your processes for daily operations and quality management and then create your Quality Manual, you use the terms that suit each process. When the standard talks about “product realization,” for example, it means “healthcare delivery.” Its “customers” are your patients and anyone else who derives value from your work.

Some common misperceptions include:

  • Failing to recognize what is not appropriate, not needed, or not required. In the complex environment of healthcare delivery, too many layers of complexity, sign-off, and documentation detail can overwhelm staff and management.
  • Trying to implement the entire system at once, rather than identifying and starting with the processes where improvement will provide the greatest benefit. An “all-or-nothing” policy puts such demands on resources that it, too, can overwhelm you. Typically, implementing ISO 9001 will require two to three years.
  • Failing to explain the process of change, and its benefits, to the entire organization. Everyone must understand how they, too, will benefit and why they must be involved. (The buzz word here is “buy-in”.) And senior management must be the first to buy in.
  • Assuming that “audit” is a once-a-year process by someone else, and that “follow-up” only means reading an audit report. Regular internal audits, continuous monitoring, timely analysis of problems, and rigorous follow-through are essential to the quality process.
  • Making the auditor God. In ISO 9001, one size does not fit all. The standard’s flexibility makes it your right and your duty to develop a quality system specific to your operations. Unfortunately, some auditors are too rigid in their interpretations, or are trying to create an easier job for themselves, and will insist that all of their clients use the same forms. In such a case, your response should be, “Where in the standard or my procedures am I asked to do that?”
  • Failing to recognize the importance of a robust document management system that will simplify data entry and retrieval and still be easy to change, with excellent version control so that users never see outdated forms or guidelines. Implementing ISO 9001would be a labor-intensive challenge in a paper-based world.
  • Failing to start and end with the customer’s perception of quality.

What’s Good About ISO 9001 is Good for Healthcare

ISO 9001’s eight principles outline what is needed for a good (if not great) quality management system. Several of them bear repeating.

In Medical Quality Systems: The Elusive Goal of Quality in Complex Systems, referenced above, we present the modern definition of quality:

Quality is the ability to deliver, through a consistent and efficient system, a product or service that meets or exceeds a customer’s rational value expectations. … This is a critical concept for healthcare. In industrial systems, it is possible (although not desirable) to operate with a very high scrap rate and utilize only product that meets specifications. In healthcare, each of these pieces of ‘scrap’ is a failure to treat a patient properly, resulting in waste, pain, injury, and even death.

In other words, there is no industry that should be more involved with its customers’ rational value expectations than healthcare.

We also quote W. Edwards Deming: “In God we trust; all others must bring data.” (Deming developed the Plan-Do-Check-Act quality tool and also introduced modern quality methods to Japan in the 1950s.) ISO 9001’s seventh principle restates this requirement as, “Factual approach to decision making.”

Then there is the fact that healthcare delivery is a complex, non-linear system of interacting processes. ISO 9001 specifies a systemic approach to managing such a system. It is the only way to achieve the broad oversight necessary to monitor both the individual processes and the interactions. With this systemic approach comes the flexibility to develop a system that incorporates healthcare-specific standards, guidelines, and metrics.

Finally, there is the requirement for continuous improvement. In addition to periodic audits by an outside registrar, ISO 9001 requires regular internal audits by employees who have been trained for the task. On top of that, it requires continual monitoring of your processes, followed by review and analysis of each problem and timely follow-up in the form of a corrective action that is then monitored to make sure it worked. If the outside auditor does find non-conformities, the mechanisms are in place to discover the root cause quickly, correct it, test the correction, and then report back to the auditor that the problem has been fixed. With ISO 9001, you have a meta-management system that gives you constant visibility into your performance so that you can quickly repair problems and know how you are doing at all times.

Compare this process with the typical accreditation process that takes place currently in most hospitals: a periodic inspection at annual intervals (at best), a bulky audit report, and little or no insight into the root cause and related effects of the issues that led to your failing the survey and possibly losing your accreditation.

What to Prepare For

Pay for Quality, Pay for Performance, ACOs, bundled payments, and other initiatives are here and growing. To succeed in a paradigm shift that drives healthcare delivery toward quality, hospitals need a framework that works and is easily understood. ISO 9001 provides that framework. By incorporating ISO 9001 into the CoPs accreditation process, DNV has made the standard a part of the expanding quality glossary in healthcare. The argument is hard to ignore: Succeeding with ISO 9001 gives you the best chance of being paid. This realization will ensure that hospital managers look hard at ISO 9001 and its potential for improving quality in their healthcare delivery system. By taking the next step and offering full ISO 9001 certification, DNV has also raised the bar for healthcare quality. The TJC/SGS partnership only adds weight to the argument. But, however important, this is only the first impulse in the quality revolution.

ISO 9001 requires quality control along the entire chain of processes involved in providing healthcare services, a chain that includes verifying the quality of every subsidiary service, from housekeeping and laundry to purchased supplies to the services of outside clinical service providers. This could very well intensify the drive toward mergers and the absorption of private provider groups into hospital environments. At the very least, outside providers will feel the pressure to become certified themselves, and will be required to adhere to ISO-based systems while in hospital facilities. Either way, the quality of clinical care and the operations of the departments that provide it will both be affected.

ISO 9001, with its focus on customer requirements and perception of satisfaction, will also speed the drive for transparency in reporting patient outcomes. The standard doesn’t require management to announce its quality goals or achievements, but patients will notice the PROs, surveys, and other metrics and will begin to wonder. Wise hospital managers will make public the data behind their seals of approval. Eventually, the general public will know what to look for (both the seal and the data); if they don’t see it, they’ll demand to know why. Even providers who don’t serve Medicare/Medicaid patients will find they need to be certified in order to attract and keep patients.

Hospital managers and the quality experts on staff face two contradictory pitfalls: waiting too long to implement ISO and rushing in before they fully understand the purpose, principles, and processes of the standard. When the time comes, everyone in the organization must understand the purpose, the goal, and the part they play in succeeding. Getting the right training for management and staff will be key to the process. And every hospital will find it must strengthen and maintain its focus on customer need, perceived satisfaction, and “rational value expectation.” Luckily, ISO 9001, in its principles and requirements, clearly outlines the quality process, from the initial definition of processes through the documented follow-through on every correction made to improve on the improvements.

Implementing ISO 9001 is not a task you can delegate to a single manager or subcommittee. It is a strategic decision that affects the entire organization, top to bottom and, hopefully, for the rest of its existence. ISO 9001 – used correctly – is a transformational tool.

Barreling Down the Yellow Brick Road

Preface: It is a
pleasure to introduce my old friend Rory Laughna to the readers of the blogosphere.
Rory is one of the best credit guys that I have ever know, and I appreciate him
sharing some thoughts regarding the wild (and paradoxical) new world of cheap
money and tight credit. I hope that you enjoy his insights as much as I do.
Thanks Rory

Musings of a Roaming Buffalo

Barreling Down the Yellow Brick Road

Rory Laughna

April 18, 2013

 

The nature of financial risk is a simple but frequently unwelcome concept.  We save and invest dollars to receive more in return in the future, so it is very inconvenient when all of it does not come back.  It is especially unpleasant to consider possibilities that nothing comes back.   This is not to criticize risk taking.  To the contrary, paraphrasing the great Chico Escuela, the leverage business has been bery bery good to me.

 

 

 

                Chico

 

Risk assumptions supports value creation and improved living standards.   However, refusal to recognize risk can lead to disruptive consequences, particularly when business and personal plans are based on unrealistic expectations.  My purpose is to highlight the value of honest risk assessment.

The past week’s plummeting gold price gave us a great example of inherent, but opaque risks.  I have always struggled with the concept of a mineral with so little practical utility enjoying status as the ultimate store of value.  There is much debate over whether this makes sense but there is no denying that gold commands a meaningful allocation within many investment portfolios.  In fact many of the pro-gold arguments are persuasive, particularly the insulation it provides from counterparty risks and currency debasement.  Although I prefer assets offering tangible utility, I appreciate the allure of gold.

Playing in Gold

 

Harkening back to the price plunge, I heard one pundit comment, “I’ve never seen anything like this”.  Well, in the 40 some years since we abandoned the gold standard, gold has held positive value and indeed performed very well during periods of hyper monetary creation.  Still, various inflection points of value impairment are observed, some very significant:

Gold Price

Notwithstanding my friend proclaiming an unprecedented event, I suggest there is not universal amnesia among gold investors, and they rationally accept fundamental price volatility as being consistent with its store of value role.  So gold is basically an insurance policy against currency debasement, or an inflation hedge.  One may interpret its periods of price strength as indictments of reckless fiscal and monetary policies, and price weakness as an indicator of diminished concern. The core function of gold is therefore a risk mitigant.

Low interest rates challenge investment objectives.   So why not borrow nearly free dollars to buy the ultimate store of value?  Presto!  With even less heavy lifting than spinning straw into gold, the road to Alpha is yellow bricked.  Large investors acquire gold through strategies intended to enhance gold from an insurance policy into a superior investment instrument.

Stram into Gold

 

But alas, hazards abound.  The laws of supply and demand govern dollars dropping from helicopters just as it does bushels of corn and Ipswich IPA, but dollars are subject to other factors.  So while the price is driven towards the bargain basement, the lenders are inclined, and are certainly reminded by another side of the regulatory regime, to be stern about getting their dollars back.    “Margin lending” describes the process of brokers lending dollars to their investors.  Strict rules limit how much margin can exist initially between the level of funds borrowed and the value of the investment, and more importantly, how much margin must be maintained while the loan is outstanding.  If the investment value declines, the investor is likely to be required to repay the loan to a greater extent than the loss in investment value.  This is the dreaded “margin call”.   If a fundamental factor significantly diminishes investment value, margin calls can force investors to sell their investment, possibly at the worst possible time, churning excess supply onto the market.  It can become a vicious circle magnifying the price drop.  The gold spinning wheel becomes a turbocharger flushing gold dollars.

 Down the drain

 

Some have theorized a margin call on a significant hedge fund accelerated the recent price plunge. It is interesting that as this is being written that is a matter of speculation, so the causes are not transparent.  I do not know, nor will I pretend to know the right price of gold.  I do believe that while over time, supply and demand fundamentals will support an average gold price at its natural level, the use of cheap leverage stokes and magnifies price swings.  This is price volatility and a serious threat to anybody who may need their invested dollars back.  Does margin just create price volatility, or does it also support more efficient trading and therefore a better insurance policy?  We can debate and maybe reach a consensus opinion or not.  But I do know this, invest while the turbocharger is fired hottest, and the sucking sound from swirling dollars may be deafening.

 Turbo

Nothing is novel in the foregoing, but we do have a topical example of a systemic risk.   There are many examples of current investor objectives that seem to be inconsistent with money market conditions.  Maybe cheap dollars will support enough productive investment to make it all work.  Or maybe the lure of turbocharged returns is a convenient excuse to ignore risk.  It seems to me that setting a target return and then reaching for ways to achieve it leads perilously close to encountering a misfiring turbocharger.

I suggest the reverse approach of honestly recognizing tolerance for losing all or part of an investment, accepting the corresponding constraints on likely returns, and then plan business operations or personal affairs accordingly.   Simply, this process establishes”risk appetite” as a foundation.   Widespread pursuit of return absent thoughtful risk appetite recognition is a serious systemic risk.   Disagree?  Well, consider the 10-year treasury trades around 1.70 %, pension plans depend on realizing 7%-8% future annual returns, bond fund managers indicate derivatives (leverage on steroids) will be used to preserve recent returns, and an entitlement shortfall approaching $50 trillion looms over the next 75 years.  How consistent are our plans with our risk appetite?

Fear, Greed, Stupidity and a Trade for the Ages

Fear, Greed, Stupidity and a Trade for the Ages

April 8, 2013

Wes Chapman

                Yin Yang

 “Three great forces rule the world: stupidity, fear and greed.”

Albert Einstein

Traditional Chinese Medicine recognizes the concept of two great opposing forces – the yin and yang. Not too surprisingly these are captured by opposites: male vs female, light vs dark, sun vs moon.

In modern finance the yin and yang could be considered to be the great two investment motivators: fear and greed. Consider my absolute wonder last Friday when a quick perusal of the day’s headlines finally recognized that both fear and greed have merged into the wonder trade for the ages – borrow short from the Fed, and lend long to the Treasury. According to the headlines in the popular press this is both incredibly lucrative, and absolutely safe.

Better still, this trade has such beneficial macro-economic impact that the Japanese have decided to double down on this bit of financial legerdemain, and have decided to double the profligacy of our own Federal reserve, and create money to buy bonds equal to 1% of GDP per month in the hope of stimulating real economic growth via currency debasement. Good luck with that.

 

Haven Flows Push Treasury Prices to High for the Year

WSJ, 4/4/2013

They babble about a bubble, but it’s not

Treasuries popular because they’re safer”

USA Today, 5/5/2013

Japan starts monetary revolution,

All but scattering cash from a truck

Financial Times, 4/5/2013

The minute that fear and greed merge, the great limits on insanity are eliminated – all that remains is the stupidity noted by Einstein. As in the case of the many debt crises of the immediate past, we are accelerating as we approach the edge – and it’s time for the whole world to play. Japan pushes the accelerator of monetary growth, all the while forgetting the hundreds of billions of dollars of worthless 100 year residential mortgages still resting comfortably on their financial institutions balance sheets.

When it comes to the high jinx of the world’s central banks, I think that the Great Emancipator had it right.

You can fool some of the people all of the time, and all of the people some of the time, but you cannot fool all of the people all of the time.”

Abraham Lincoln, (attributed)

And I’m still mad that I never put on the one-way trade for the ages – remember it will work until it doesn’t.

A Moosilauke Climbing Haiku – Prouty Prep Hikes

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A Moosilauke Climbing Haiku

April 7, 2013

Wes Chapman

Preface:  You’re probably getting a little bored reading repetitive blogs about familiar climbs. In an attempt to keep it fresh, I’m going to boil the essence of the hike down to a limerick or haiku (hopefully humorous) and let the pictures tell the story. In response to a critique from one of my daughters (a heartless critic), I’m embedding video via hyperlinks in the poem. We’ll see how it goes.

 Moosilauke April & SLoaf 015

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Winter rages on high

Spring in the valley below

Peter stayed in bed

 

 

Moos Summit

Moosilauke still locked in winter

Rick at the summit

Rick Morse getting blown around at the summit

Pete in bed

Peter stayed in bed

Whiteface & Passaconaway – A Prouty Prep Hike

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A Prouty Prep Hike

Whiteface & Passaconaway

11.2 miles, 4,019 & 4,043 ft. respectively

Via Blueberry Ledge, Rollins and Dicey’s Mill Trails

February 23, 2013

Wes Chapman

For those of us in western New Hampshire, getting to the eastern 4,000 footers is nettlesome – requiring lots of driving over bad roads in winter. It is, however, well worth the effort. Whiteface and Passaconaway are the jewels of the Sandwich Range, and make for a splendid winter hike.

 Map of the climb

The route

Passaconaway is named for an Indian Chief of the Pennacook Tribe in what is now Massachusetts, who lived and ruled during the period of the Pilgrim settlement – beginning in 1620. Passaconaway comes from the combined word Papoose Conewa, meaning Child of the Bear. Passaconaway was revered by Indians and white settlers alike, and was referred to in his later years as St. Aspenquid by the English. He is described as a giant, possessed of magical powers including the ability to make water burn, and spontaneously generate lightning – very cool. The mountain named after him comes complete with a small river named after his son, Wonalancet, and together with Whiteface forms a basin which includes a fair amount of old growth forest. This is a beautiful area, and is to the outdoor program at UNH what Moosilauke is to those of us at Dartmouth – the heart and soul of their outdoor program.

 Passaconaway

Passaconaway from Whiteface in 2008

Chief Passaconaway

Chief Passaconaway in a dour mood

I persuaded my Kilimanjaro climbing partner – Rick “Rambo” Morse to come along on the climb, despite a persistent light snow and low clouds.

Rick on the Blueberry Ledge Trail

Rick “Rambo” Morse on the way up Whiteface

Rick on the top of some ice

Negotiating some steep ice near the summit of Whiteface

Wes Near the Summit

Wes near the Whiteface summit

Steep near the top

Steep and icy near the summit of Whiteface

 The summit of Whiteface was socked in clouds and deserted. We ate a quick lunch and headed over to Passaconaway via the Rollins Trail in the clouds and snow. I was reminded that the last time I ate lunch here there were naked women – probably wood nymphs – sunbathing on the warm rocks at the summit. I banished the memory and headed out – the harsh realities of chilly February stifling the wonderful recollections of a warm September.

The Rollins Trail is always long, but it has been blocked in areas by winter blow-downs and the going was slow. We saw some moose tracks and sign on the way over to Passaconaway, but not much else. The summit of Passaconaway is quite heavily forested, and with the storm afforded no views. We headed down the valley at flank speed – hopefully to get out before the storm socked us in.

On the way out I was reminded of the story of Passaconaway’s burial – he reputedly rode a sled pulled by a team of wolves to the top of Mt Washington (Agiocochook, or “Home of the Great Spirit”) where he spontaneously burst into flames and went to join the Great Spirit. It’s called going out in style.

Blow downs Rollins Trail

Blow-downs on the Rollins Trail

Summit of Passaconaway

The unremarkable summit of Passaconaway

The best view of the trip may be the little farm at the end of the trail, with Mt. Wonalancet in the background. This is a fun hike any time of year, but I recommend warm days when the wood nymphs are about.

Farm in Summer

End of the trail in September

Farm on exit winter

Adios, from Mt. Passaconaway in February