Conditions of Participation – Quality Improvement


Maybe the most frustrating element of Quality Improvement for us has always been that there is not a clear definition.  One agency may ‘QA’ notes as they come in but never go any further.  Another may collect data on countless areas of concern but never put into place a plan for improving those areas.  There are those agencies with a program that is great but so complex and time consuming that it never gets done.

All of that is changing.  Effective January 18, 2018, agencies must meet specific criteria in their Quality Assurance as written into the new Conditions of Participation.  The Condition reads as follows:

(484.65) The HHA must develop, implement, evaluate, and maintain an effective, ongoing, HHA-wide, data driven QAPI program.  The HHA’s governing body must ensure that the program reflects the complexity of its organization and services; involves all HHA services (including those services provided under contract or arrangement); focuses on indicators related to improved outcomes, including the use of emergent care services, hospital admissions and re-admissions; and takes actions that address the HHA’s performance across the spectrum of care, including the prevention and reduction of medical errors. The HHA must maintain documentary evidence of its QAPI program and be able to demonstrate its operation to CMS.

The short version:

  1. Your agency must have a QA program that is based on data
  2. It must reflect the complexity of the agency and include all services provided.
  3. Focus on indicators related to improved outcomes including:
    1. Adverse Events
    2. Use of emergent care services
    3. Hospital admissions and readmissions
  4. Takes action to address performance across the spectrum of the agency
  5. The agency must document its program and be able to show compliance to CMS.

This is not hard.  It does require time and buy in from employees in every department of the agency.  Agencies who invest the resources to make this happen will find themselves at the top of the list for star ratings and be every referral source’s darling.  But, it will not happen unless and until senior leadership in the agency buys into the process. With Gusto.

The standards that will be surveyed to determine compliance are similarly easy, but they are comprehensive.  Here they are  (paraphrased):

The agency must be capable of showing improvement in indicators for which there is evidence that health outcomes, care and patient safety will improve when action is taken to address those indicators  In other words, the indicators chosen by your agency must be useful.

And agencies must measure, analyze and track indicators, including adverse events and other aspects of performance that enable the agency to assess processes of care, services and operations.  Simply put, agencies will review data related to their chosen indicators to determine if their plans are working and the plan must include the frequency at which data is collected.  The governing body must approve the frequency of data collection.

Standard – Program Data

The agency must use data from OASIS when applicable as well as other relevant data in the design of its program to:

  1. Monitor effectiveness of service and quality of care
  2. Identify opportunities for improvement

The governing body is the person or group of persons who assume full legal authority and responsibility for the agency’s overall operations.  Ultimately, the buck stops at the governing body.  They write checks and approve budgets.  They can veto decisions.  It may be the owner of a small agency or a group of executives appointed by the boards of publicly traded companies.  Think CEOs, CFO’s and any other person with a job title beginning with a capital C.

So, the Governing body approves the data that will be collected as well as the frequency.  That means that if the data is not collected or is useless or does not result in improvement; ignorance on the part of the governing body will not be an acceptable excuse.  Truly, it never was acceptable but now it is in writing.

Medicare has already given agencies three indicators they expect to see written into the Quality Assurance plan; hospitalizations, emergent care and adverse events.  You’re halfway there but to be effective means determining why patients are visiting the hospital and receiving emergent care.  You already have much of that information in your transfer assessments.  You should know what percentage of your patients are hospitalized because of falls, wounds, medication errors, etc.  If more than a quarter of your patients are going to the hospital for unknown reasons, it could be that the clinicians completing the assessment aren’t taking the time to find out.  Now is the time to instill the importance of taking the effort to get the information required to complete a transfer assessment.

Potentially Adverse Events must be investigated, and action must be taken to prevent future occurrences.  This is not new but is overlooked with an alarming frequency.  Adverse Events retrieved in OASIS reports often have diminished value due to of the age of the data, but you can investigate Adverse Events as they happen while all staff involved with care are still employed and memories are still fresh.  The names of the Potentially Avoidable Events are self-explanatory, and a list provided to staff who complete discharge assessments or billing audits may be useful for identification prior to generating an outdated report.

Monitored Measures to Demonstrate and Track Sustained Improvement

For all activities undertaken to improve quality of care by the agency, there must be measures that are monitored to demonstrate improvement and track sustained improvements. It is a common occurrence for education to yield immediate results for a brief period of time with a return to baseline after a few weeks.

Performance Improvement Projects

Agencies must conduct performance improvement projects. The number and scope of distinct projects must reflect the scope, complexity and past performance of the agency.  Documentation will include a description of the project, the underlying reason for undertaking the project and measurable achievement.  The nature of the project is up to the agency but it must be related to data that has been and will be collected.

Governing Body Responsibilities

Finally, the governing body is responsible for ensuring that:

  • An ongoing program is defined, implemented and maintained
  • The Quality Assurance activities address priorities for improved care and patient safety and that all actions are evaluated for effectiveness.
  • Clear expectations for patient safety are established, implemented and maintained
  • That any findings of fraud or waste are appropriately addressed.

Regarding fraud and waste, the interpretive guidelines go on to say:

In the event that the HHA identifies a possibly illegal action by its employees, contractors or responsible/relevant physicians, it is the responsibility of the HHA to report the actions to the appropriate authorities according to the individual State laws and the nature of the action(s).

I have taken liberties with the actual language.  The full text of the new Conditions of Participation can be found here.  Ultimately it is the responsibility of each agency to understand the CoP’s and we hope we are able to help you.  But we are not now and never will be a substitute for any regulatory body or document.

Next up in the new Conditions of Participation is Infection Control which will be discussed in detail next week.  For now, agencies will do well to pull all relevant OASIS reports and outcomes so that a plan can be put in place.

As always, if you need help implementing the new Conditions of Participation, you know who to contact.

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Nina Pham


 

The CDC, among others, have suggested that perhaps more training is needed to ensure that direct health care workers are properly using protective equipment.   According to that line of thought, poor Nina Pham simply did not know what she was doing when she picked up a touch of Ebola from her patient.  If only she had more education on how to put on gloves and a gown, this whole disaster could have been avoided.

I think not.

I posted my dismay regarding re-educating nurses on FaceBook and was amazed at how smart my friends are.

One non-nurse, Michelle said that education was a way to protect the facility.  In other words, when a policy is violated, the hospital is able to assure any surveyor or lawyer that they did, indeed, provide the education and training and have therefore met their responsibility.  Sadly, a successful healthcare facility (and by successful, I mean isn’t closed down) must cover all bases to minimize damages.  I would probably waste time and resources re-teaching PPE, too if I had to make the decisions.

She also pointed out that maybe protocols are not strictly enforced when the risks are lower which could lead to bad habits.  I agree.  Ever notice how MRSA is already a problem when we start monitoring hand hygiene?  (I love that.  Hand hygiene – soon there will be an aisle in the supermarket for hand hygiene products instead of soap, antibacterial gel and hand lotion.)

Lisa Selman Holman pointed out how very miserable PPE is to wear.  She is right.  It is hot and sticky, nothing fits right and it is ugly in the most unforgiving way.  I have yet to figure out how looking like Big Bird assists in the infection control process. Healthcare workers, especially those with a fashion sense, can’t wait to take it off.

If ever there was a time to spend money, this would be it.  Athletic clothing manufacturers have done amazing things with sports gear.  It seems like a clothing manufacturer who exists because they make comfortable, functional clothes that can wick away perspiration, kill enough germs to smell good and keep a body warm in water might be able to help design something comfortable, disease proof, easily taken on and off  with the assistance of an infection control specialist.

Sara Kawaguchi came up with the idea of having two people involved – one present simply to observe.  I love this idea and it is cheap to do when considering the stakes.  Having never met Miss Pham, I can only assume that she didn’t tear a glove, look at it and say, ‘Oh darn,’ and carry on with restarting an infiltrated IV line.   If she breached protocol, it was likely unnoticed by her.

My cousin, Steve, is a physician and his response was simple.

1) we are human
2) we make mistakes
3 there is no room for a mistake here, in flight or in surgery

There’s a lot of truth in that but we can minimize mistakes.  Even the world famous Quality Assurance plan designed by Toyota, Six Sigma refers to only six errors in a million.  When it comes to Ebola, nobody wants to be one of the six.

The Checklist Manifesto by Atul Gawande is written by a surgeon who almost killed a patient because he forgot to do something very simple and standard prior to surgery – type and match blood.  After this near catastrophe that left his confidence shaken, he set about researching how to prevent errors.  It turned out that aviation history was marred by the crash of the first B17 in which several people died.  It almost took Boeing aircraft out of the game completely.  The solution included a checklist which enabled the (highly skilled and trained pilots) to fly 12 planes a total of 1.8M miles without incident.  It is now used universally.

Checklists are not designed to educate anyone.  If you have ever turned in visit notes only to find out that you forgot to write a narrative because you were interrupted, you are prone to human error.  If you have ever been called about a bill you know you paid only to find the stamped envelope in your purse, you could have used a checklist.  They are designed to let you pick up where you left off in the event something slips your mind, you are preoccupied or there is chaos all around you.  They ground and center the user.

There are undoubtedly numerous approaches to improving the safety of healthcare workers but re-educating the staff in a critical care unit on how to put on and take off PPE is an intervention for the hospital – not the nurses.  Don’t tell me that the staff in an intensive care unit requires more schoolin’ to put on gowns, masks and gloves.  Make them more comfortable so they aren’t urgently ripped off like they were on fire the minute you clear the room.  Have someone else watch.  Use a check list.  Doing more of what was done in the past because it didn’t work doesn’t quite make sense to me.

What the healthcare staff needs the most is a cure for Ebola.  When it comes to caring for a patient with Ebola, especially at the end of life, perhaps the most important changes will come about from the staff who were actually there doing the job.  If the blame game stops and the focus is directed to increased protection of healthcare workers, why not consult that handful of clinicians who are the only ones in the United States to have cared for Ebola patients in US hospitals?

I know that you join The Coders in wishing Godspeed to Nina Pham’s recovery.  She was able to be there for a patient isolated from his family and friends when he needed them the most.  People like Nina Pham do not put their own lives on the line for a paycheck.  She has a calling and I pray she will be back at work sooner than later.

Also,  let’s not forget that Nina Pham is not alone.  A few dozen other healthcare workers who took the same risk as Nina Pham and so far, have been free of symptoms.  These include the staff in Dallas as well as Nebraska and GA where two other Ebola patients have been treated.  They are no less heroic because they have not contracted Ebola; they just haven’t made the news and I hope they don’t any time soon.