Thursday, November 28, 2013

Building Unity Farm - Thanksgiving on the Farm

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Thanksgiving is a time for family and friends to reflect on the past year, be grateful for the good things that happen every day, and consider the journey we're all on, which is hopefully headed in a positive direction.

On a farm, this day of thanks is very personal.    As with last year, the foods we prepared were either grown at Unity Farm or at a farm within one mile of our dining table.   There was one exception - the cranberries were from a bog on Cape Cod.

We boiled turnips and roasted root vegetables.   We picked mixed lettuce from the hoop house.   We baked pumpkin and apple pies with fruit picked from our orchard. We opened bottles of Unity Farm sparkling hard cider made this Fall in the cider house.  We made stuffing from chestnuts and oyster mushrooms, fresh picked from our mushroom farm.   Next year we'll have shitake to add to the table, but this winter the logs are still in their mushroom growing phase.






The alpaca got an extra helping of alfalfa mixed with molasses.  The dogs enjoyed a few fresh eggs.  The chickens, ducks and guinea fowl got fresh lettuce.

I've described life at Unity Farm as joyful chaos.  There are always chores to do.   There are no vacation days or weekends.   But somehow, I never feel that hauling hay, filling water buckets, turning compost, splitting logs and the constant movement needed to support the plants and animals constitutes work.   We spent the day as a family doing everything needed to support the community living on the farm.   My daughter split ash and black birch logs for the hearth.  I chainsawed fallen trees and branches from yesterday's storm (we had 40 mph winds and 3 inches of rain).  My wife watered our winter produce in the hoop house and planted new vegetables - the hoop house was 80F at midday while the outdoor temperature never rose past 32F.

The family spent the day together doing tasks that benefitted all.

Tomorrow, we have no shopping planned, just tasks that will further help us prepare for the heavy snows that are likely to start in a few weeks.  

This was my first Thanksgiving without my father, so we took time at dinner to pay tribute to those not present - my Father, Kathy's mother, and those who we've known in life who are no longer with us.

I hope you have a peaceful day and many things to be thankful for.   Although we all face many challenges, hopefully you still have a sense that the future will be even better than today.

Wednesday, November 27, 2013

Rethinking Certification

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As stakeholders in payer, provider, and government communities debate the optimal timing of ICD10, Meaningful Use Stage 2, ACA, and HIPAA Omnibus rule deadlines, it's becoming increasingly clear that many hospitals which attested in 2011 and 2012 will not have their 2014 edition certified software installed, training completed, and workflow re-engineered in time for the Stage 2 attestation deadlines.

Now that we have experience with two stages of Meaningful Use, it's also clear that a three year cycle is needed to ensure safe, high value, well adopted, introduction of new IT functionality.

Part of the problem, as I've discussed previously, is that the certification criteria are overly burdensome and in many circumstances disconnected from the attestation criteria, requiring very prescriptive features that go beyond the intent of Policy Committee and Standards Committee.

How did this happen?  When Meaningful Use Stage 2 regulations were being written, ONC entered a "quiet period" in which smart people wrote regulatory language and certification scripts isolated from the rest of the world to ensure there was no bias introduced.   This was a "waterfall methodology" in which elaborate specifications and a long planning process was followed by an isolated development process resulting in a single huge deliverable with little opportunity to validate the result, pilot the components, or revise/improve the product after the fact.  The flaws in the Stage 2 certification scripts are an artifact of the regulatory process itself.

Healthcare.gov taught us that waterfall approaches are risky.    A better approach would be to create certification scripts using an "agile methodology".   Standards and scripts to test them could be developed outside the regulatory process, with iterative stakeholder feedback, testing of components, and rapid cycle improvement.   The regulatory process could point to the standards which would have accompanying implementation guides and test scripts.   There would be no "quiet period" or isolation in the development of certification scripts.    Such an approach would significantly reduce future certification burdens.

In addition to this, I recommend an even more radical redesign of certification.

We should maintain attestation as a demonstration of performance, but limit certification to rigorous standards adoption and interoperability, not prescriptive functionality.

What do I mean?

The Meaningful Use Workgroup believes decision support should be expanded in the future.   I agree.   Although they are now looking at outcomes that demonstrate the use of decision support, their initial work included recommendations for very prescriptive decision support certification criteria including:

Ability to track CDS triggers
Ability to flag preference-sensitive conditions and provide decision support materials for patients
Check for a maximum dose /weight based calculation
Use of structured SIG standards
Consume external CDS interventions
Use info in systems to support maintenance of lists

In effect, this tells vendors how to enhance clinical decision support features.

Let me use analogy.

Suppose that the government decided USB thumb drives are a good thing.   Not only would they specify a USB 3.0 standard, they would require it is black, rectangular, and weighs 2 ounces.    Such prescriptive requirements would stifle innovation since today's USB drives might be in the shape of a key or even mimic a sushi roll.

When evaluating the success of the US healthcare IT program, Congress tends to focus on interoperability - why are there gaps in DOD/VA data sharing or few seamless transitions of care among inpatient and outpatient facilities?

If certification focused entirely on interoperability, EHRs would be a bit more like USB drives.  They might be big or small, black or red, key shaped or sushi shaped.  However, they'll work with any device you plug them into.

I've spoken with many EHR vendors (to remain unnamed) and all have told me that they created software that will never be used by any clinician but was necessary to check the boxes of certification scripts that make no sense in real world workflows.

If certification required rigorous demonstration of outbound and inbound interoperability with no optionality in the standards (use this standard OR that standard), Congress will be happy, patients will be happy, and vendors will be happy.

Once we come up for air after ICD10, MU2, ACA, and HIPAA, I'll be watching any MU3 planning very closely to ensure we do not again make the same mistakes with certification scripts that are untested or too prescriptive.   Let's all focus on universal adoption of enhanced interoperability as a measure of success.

Thursday, November 21, 2013

Building Unity Farm - Making the Perfect Cider

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In North America, we think of apple cider as a non-alcoholic drink available for a few weeks in the Fall.   Before prohibition, most cider was fermented to 4-6% alcohol as a means of preserving it.  Cider was available from casks throughout the year.  John Adams drank a quart for breakfast every morning.   Puritan laws urged moderation and suggested no more than half a gallon of cider be consumed per day!

When I use the term cider, I mean fermented cider.

Over the past few years, there has been a resurgence of interest in craft ciders from such producers as Farnum Hill (Poverty Lane Orchards in Lebanon, NH), West County (Colrain, MA), and Julian (San Diego area)

Having tasted dozens of craft ciders, I know that creating the ideal Unity Farm cider will require significant experimentation.   I've read 5 books about traditional cider making and their collective advice is to balance a blend of sweet, sharp (tart), aromatic, and bitter (tannic) apples using this template

Sweet (30-60%)
Sharp (10-40%)
Aromatic (10-20%)
Bitter (5-20%)

The Unity Farm orchard yielded some apples this year, but not enough to press a batch of cider, so we purchased apples from local farms in Sherborn.

Last weekend we pressed 400 pounds of apples as follows

Sweet - Empire (1.5 bushels), Baldwin (1.5 bushels), Cortland (1 bushel), Spencer (.5 bushel), Macoun (.5 bushel)

Sharp - Stayman Winesap (1.5 bushels), Northern Spy (1 bushel), Granny Smith (.25 bushel)

Aromatic - McIntosh (1.5 bushels)

Bitter - although we wanted to add crab apples or Newtown Pippin, none were available

This mixture created 18.5 gallons of juice with a ph of 3.65 and a specific gravity of 1.055.  Using the template above, our distribution of apple types was

Sweet  54%
Sharp  30%
Aromatic 16%
Bitter 0%

I sterilized the cider with 50ppm of Potassium Metabisulfite (appropriate for a cider with a ph of 3.65) and let the sulfite decline for 48 hours before inoculating with Champagne yeast and yeast nutrients.    I used a 60 liter Spiedel fermenter.

The initial fermentation will take 2 weeks and then I will rack the cider and allow 2 additional weeks for the end of primary fermentation.   I'll assess the flavor and ph at that time and if necessary will encourage a secondary malolactic fermentation to reduce total acidity.

This batch will be still cider (not carbonated) so I will sulfite again and bottle into 22 ounce brown glass bottles.  I'm using an early 1900's cast iron bottle capper to ensure a good seal.

At Christmas time, I'll taste our sparkling and still cider experiments to gain a better understanding of the apple blending art.

We're looking forward to the output of our 33 apple trees in the next few years.    Using the sweet, sharp, aromatic, and bitter template we planted these trees in the Unity Farm orchard:

2 Empire (sweet)
  Braestar (sweet)
  Northern spy (sharp)
  Whitney Crab (bitter)
  Ben Davis (sweet)
  Winesap (sharp)
  Granny Smith (sharp)
  Cox Orange Pippin (sharp)
  Pink Lady (tart)
2 Red Delicious (sweet)
  Fuji (sweet)
  Macoun (sweet)
  Arkansas Black (bittersharp)
  MacIntosh (aromatic)
  Gala (sweet)
  Roxbury Russet (aromatic)
  Rome Beauty (sweet)
  Honeycrisp (sweet)
  Sheep nose (sweet)
  Cortland (sweet)
3 Kingston Black (bittersharp)
  Ashmead's Kernel (aromatic)
  Newtown Pippin (bitter)
  Golden Russet (aromatic)
2 Wickson's Apple (tart)
  Nehou Apple (bittersweet)
  Baldwin (sweet)
  Blacktwig (tart)

Most are heirloom cider apples from the UK and France.

To me the perfect cider is crisp, complex, and never cloying.   In a month, I'll have a better idea how close I've come.

Wednesday, November 20, 2013

Fine Tuning the National Healthcare IT Timeline

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I've recently written about healthcare.gov and the lesson that going live too soon creates a very unpleasant memory.

As I work with healthcare leaders in Boston, in New England, and throughout the country, I'm seeing signs that well resourced medical centers will struggle with Meaningful Use stage 2 attestation, ICD-10 go live, HIPAA Omnibus Rule readiness, and Accountable Care Act implementation, all of which have 2013-2014 deadlines.

People are working hard.   Priority setting is appropriate.   Funding is available.

The problem is that the scope is too big and the timeline is too short.

What are the risks?

Because of the complexity of the Meaningful Use stage 2 certification process, many stage 1 certified products have not yet been certified for stage 2.   Those that are stage 2 certified have only been recently introduced into the marketplace, making upgrades, training, testing, and full implementation before July 1, 2014 (the beginning of the last reporting period for hospitals which attested to stage 1 in 2011 and 2012) very challenging.   I believe that we could see hundreds of hospitals fail to attest to Meaningful Use stage 2 by the current deadline, despite their best efforts.

We learned from healthcare.gov that end to end testing with a full user load and complete data set is important to validate the robustness of an application.   ICD-10 go live for every provider and most payers (other than Workman's Comp) is 11 months away.    Does CMS have time for a full end to end test of all functionality with its trading partners?   I am concerned that not enough time is available.    Will most payers and providers be ready to process transactions on October 1, 2014?  Maybe.   Will new documentation systems, clinical documentation improvement applications, and computer assisted coding to ensure auditable linkage between the clinical record and the highly granular ICD-10 billing data be in place?  Doubtful.    Will RAC audits discover that not enough time was available for training, education, testing, innovation, and workflow redesign?  Certainly.    The risk of a premature ICD-10 go live will be the disruption of the entire healthcare revenue cycle in the US.   The consequences of a delay in enforcing ICD-10 use are minimal.

ONC federal advisory committees are taking testimony from multiple stakeholders regarding the technology and policy readiness of provisions in the HIPAA Omnibus rule such as the Accounting of Disclosures and private pay redaction requirements.    It's very clear that more time and more research is needed before these elements of the law can be enforced.

The Affordable Care Act has many provisions including a move from fee for service to reimbursement based on quality. Quality measures were to be automatically submitted using the QRDA standard.  On November 5, CMS backtracked and announced that they would not accept the QRDA formats and all reporting for January 2014 would revert back to a manual web upload process called GPRO.   It is clear that CMS is not ready to move forward with ACA implementation on the original planned timelines.

So what should we do to fine tune the national healthcare IT timeline?

Meaningful Use Stage 2 attestation timelines should be extended by 6 months to enable recently certified products to be fully implemented in a safe and thoughtful way.    90 day reporting periods for hospitals begin October 1, 2013 and for eligible professionals begin on January 1, 2014.  Attestation must be completed within one year.  Extending attestation to 18 months will give us time to implement new software upgrades properly.

ICD-10 enforcement deadlines should be extended by 6 months to enable additional testing and workflow redesign.  The October 1, 2014 deadline may work for some providers and payers. Transaction flow can begin if systems are functional.   However, a 6 month extension will enable providers and payers to revise and improve systems before a mandatory full cutover.   We need to do this to avoid another healthcare.gov situation.

The Accounting of Disclosures and private pay redaction aspects of the HIPAA Omnibus rule should be delayed until pilot implementations can be studied and lessons learned broadly shared, likely a year.

Affordable Care Act implementation should await for maturity in the tools needed to support care management and quality reporting, likely another year.

All of these projects can be done and are reasonable components of national efforts to improve quality, safety, and efficiency.

However, the well meaning people who devised the policy principles did not take into account the operational requirements to do all this work simultaneously.   We should keep moving forward on these goals, but need to adjust the pace.    We all want to finish the race and not collapse before the finish line.

Tuesday, November 19, 2013

Social Networking for Good

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I've written about many aspects of social networking in the past such as

*Security risks and policy implications

*Support for research collaboration

*Applications in performance improvement

*Opportunities to reduce the provider documentation burden

One aspect I have not written about previously is the use of social networking for good such as fund raising for noble causes.

Just as I mentor 2-3 graduate students at a time, my wife has mentored fellow artists and supported them via Hatchfund

Although I've donated my time to various technology accelerators such as Rock Health, Tech Stars and Healthbox, I've not spent time on Kickstarter  or other crowd funding websites.

My wife told me tonight that she has made small contributions to worthwhile causes in the art, farming advocacy, and social cause areas.

Whether it's philanthropy, angel investing, or creating good karma, I find donation decisions to be very personal.    I've written many times that I want to make a difference and seeing tangible results on a small scale by using a social networking fundraising site seems more tangible than a donation to a large and anonymous organization.

Over the next year, I'll be working on creating my own social networking for good to fund innovation in healthcare IT.

In the meantime  I'll be paying more attention to crowd funding sites as I allocate my own contributions.

Thursday, November 14, 2013

Building Unity Farm - The Powder House Keeper

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One of the great benefits of owning a colonial era property is that you never know what you're going to find.

James Bullard was born in Sherborn on August 25, 1762 and died on June 30, 1828.

He's buried in our backyard.

As I've written about previously, the town of Sherborn stored its gunpowder on the Unity Farm property in the Powder house from 1800-1857. The Powder House was accessed via Powderhouse Lane, next to the Bullard Family home at 33 Main Street.   James Bullard was assigned the role of Powder House keeper, which was especially convenient since the Powder House was about 100 feet from his back door.

The Bullard Family home is now called the Sherborn Inn and the Powder House has been dismantled, although the foundation is still visible and accessible via Unity Farm's Marsh Trail.

James was married to Mary Harding on November 9, 1786.

On the day of their 227th wedding anniversary I was cutting wood on Unity Farm's Gate Path.   The late fall sun shone through the leafless forest and reflected off a piece of bluestone in the forest.   I looked closer and found that the light was coming from James Bullard's gravestone, near one of our old pasture walls.

As I looked around the grave I noticed an old cedar with something hanging on it.  Above the grave, an old wooden snow sled, silvered and shrinking with age, hung from a branch.   There's no brand, no label, and no clear attribution on the sled.     Was this James Bullard's "rosebud"?  Was his gravesite located on his favorite sledding hill on the land behind his 1700's home?



Mary Harding,  James' wife, died in 1796 at the age of 33 and is buried in the Plain Burial Ground in Sherborn.   James is buried on our farm under a mysterious gravestone in the woods, guarded by an old cedar supporting an ancient snow sled.

I'm not sure what it all means, but of all the Revolutionary War artifacts on Unity Farm, the grave of the Powder House keeper was not something I expected to find.

Wednesday, November 13, 2013

The November HIT Standards Committee

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The November HIT Standards Committee focused on the current status of certification and attestation, readiness of standards for patient generated data, ONC S&I Framework progress, and the overall HITSC workplan.

Jacob Reider, Acting National Coordinator, joined us and offered his perspective on the work ahead as a physician, informatician and marathon runner.   Our goals include meaningful use, as well as many other future looking functions required by many stakeholders in industry, government, and academia.

We reviewed the themes of the meeting which importantly focused on the scope, timing, and resources we need to be successful.  Doing too much, too fast, with limited resources is not going to get us to the finish line.

We started the meeting with a Policy update from Jodi Daniel  including FDASIA, Joint Commission and safety efforts.   An important foundation to that discussion was presentation of the current state of certified technology adoption.

Next, Leslie Kelly Hall presented preliminary high level recommendations from the Consumer Technology Workgroup for the standards required to collect data from patients and devices as well as enable bidirectional care coordination and communication with providers.

Doug Fridsma presented an S&I Framework Update of projects funded by ONC and other government agencies.  I asked the Standards Committee to comment on the scope of work - should we recommend more or less S&I initiatives given available resources?   We recognized that many of these initiatives are funded outside of the Meaningful Use process, so priority setting is up to ONC and its paying customers.

Doug Fridsma also presented the Standards Committee workplan priorities as suggested  by HIT Standards Committee members.     Although we need to separate the "mediums" into those we do and those we don't, there was uniform consensus that a focus on image exchange, quality measurement, referral workflow, record locator services, and care plans makes great sense.

A very productive meeting.

Thursday, November 7, 2013

Building Unity Farm - The Duck Pond

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As I've written about recently, Fall has been a busy time at Unity Farm.  We completed our first harvest, pressed cider, picked mushrooms, planted winter vegetables, and cared for young animals.  

Although we have a year round stream running through the farm, we do not have a pond for our ducks, deer, raccoons, opossums, and other local fauna to access standing water during the winter.

This Fall we built a small pond near the barnyard.

In New England, we have very rocky soil, so we had no shortage of boulders for pond building.   Our mushroom farming work generated many spare logs.   All the building materials for a pond were already on the Unity Farm property.

We needed two things to succeed - someone to provide pond building expertise and someone who could move/carve/assemble rocks.   Together, John Novak and Sean Cudmore created the duck pond pictured above.

The engineering includes a bog area that acts as natural filter, many plants to provide oxygenation, and a pattern of circulation that keeps the surface free of debris.

The ducks are 6 weeks old and soon will be given the run of the barnyard.   Our experience with ducks thus far is that they live for water.   Our 10 ducks drink (or groom with) about 3 gallons of water per day.  They have a talent for turning any dry soil into mud.   They're not shy about spending the day in their outdoor pen no matter what the weather.   I'm convinced the pond will be paradise for them.

Maintaining a pond in winter will be a learning experience for me.   As one of the few unfrozen water sources for nearly a square mile, the Unity Farm duck pond will be very popular.

Wednesday, November 6, 2013

Quality Measurement 2.0

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I've written several posts about the frustrating aspects of Meaningful Use Stage 2 Certification.   The Clinical Quality Measures (CQMs) are certainly one of problem spots, using standards that are not yet mature, and requiring computing of numerators and denominators that are not based on data collected as part of clinical care workflow.

There is a chasm between quality measurement expectations and EHR workflow realities causing pain to all the stakeholders - providers, government, and payers.   Quality measures are often based on data that can only be gathered via manual chart abstraction or prompting clinicians for esoteric data elements by interrupting documentation.

How do we fix CQMs?

1.  Realign quality measurement entity expectations by limiting calculations (call it the CQM developers palette) to data which are likely to exist in EHRs.   Recently, Yale created a consensus document, identifying data elements that are consistently populated and of sufficient reliability to serve in measure computations.   This is a good start.

2.  Add data elements to the EHRs over time and ensure that structured data input fields use value sets from the Value Set Authority Center (VSAC) at NLM.    The National Library of Medicine keeps a Meaningful Use data element catalog that is likely to expand in future stages of Meaningful Use.

3.   Greatly reduce the number of CQMs required by private and public entities to a consistent, manageable number.  That way we can focus on ensuring integrity of data elements used in quality measures.

This approach will create a “healthy tension.”   If HHS restricts measure developers from using an infinite number of data elements,  measure developers will express concern that available technology is limiting quality measurement.  If measure developers continue to include data that does not exist in the EHR, then developers will create burdensome add-on data entry screens to prompt providers for extra information just for the sake of CQM.

A few years ago, Jacob Reider (now the Acting National Coordinator) created these slides that illustrate how to cross the Quality Measurement chasm - modify expectations of quality measurement developers, while also enhancing EHRs with value sets from the VSAC and continuing to develop standards that support quality measurement (such as FHIR), optimizing workflow and usability.

As I've said before, I will do everything in my power to support Jacob Reider, ONC and "polishing" of Meaningful Use Stage 2.

Revising CQMs is likely to be a high priority of the HIT Standards Committee over the next year.    Watch for that discussion at the November 13 HIT Standards Committee meeting.