Summer 2018
Vol 116.1

LEGAL PERSPECTIVES

In the Trenches:

My Year of Conducting "Mock" Agency Inspections of Medical Practices

"So, you're a consultant now?  Why no longer practicing law?"  I hear those questions almost daily nowadays.  My response is always the same: "Nope.  I'm still a lawyer, and boy do I miss sitting at my desk."  The truth is ... I absolutely understand why physicians keep asking me.  I've spent the past year doing something a tad unusual for a healthcare lawyer - conducting on site "mock" agency inspections of medical practices and licensed facilities.  Physicians invite me to come to their offices, go through them from top to bottom, point out the good and the bad, remove non-compliant items, educate their staffs, and, overall, get things in tip top shape.  All of this is done as a preventative and cost-saving measure with an eye toward minimizing administrative and financial risk, promoting regulatory compliance, and improving patient health and safety.

 

The idea to start offering "mock" inspections came to me a year ago after leaving yet another hearing before a state administrative agency where my physician client had been aggressively criticized about areas of non-compliance in his medical practice.  My client faced very serious consequences for not only his wallet due to heavy fines but also for his professional license.  I kept arguing that many of the standards my client was being held to during the hearing were not written in the agency's regulations, which was met with a repeated and resounding agency response of, "He should know better."  Really?  Should my client have known better?  Why?  What resources were out there for my client?  With all that is expected of physicians in the current healthcare environment and with all of the pressures facing practitioners on a daily basis, how is it reasonable to expect him to know every single non-regulated rule governing his practice?  I couldn't answer any of those questions in the affirmative and knew deep down that something needed to be done about it.  What if doctors could have a friendly outsider come in to review compliance measures and to educate staff before agency investigators surprise them?  Something had to be done.  So, I did it.

 

I'm happy to say, these inspections have been incredibly productive.  I am starting to see real change for the better implemented in medical practices and a growing awareness of regulatory requirements and "expectations".  Physicians and their staffs are engaged with me in this collaborative process, and the right questions are being asked - in addition to, "when did you stop practicing law?"  But in all seriousness, I'm extremely proud of my clients for hearing me, actually listening, challenging me and the 'powers that be', telling their peers, and adapting to the strictures of our current healthcare environment.  I work collaboratively with medical practices to identify areas of vulnerability and to either remove them altogether or to find the most reasonable, cost-effective ways of achieving regulatory compliance within a budget.  I believe that doctors feel a level of comfort and relief having me come to their offices and always know I am just a phone call or text away.  Their staffs receive a very detailed placard indicating what to do and how to react if they are ever met with an unfortunate "surprise" at their office - because, and I have seen it before, that is always the pivotal moment when they panic, lose the ability to think clearly, and often make the wrong decision to simply let inspectors in instead of waiting for an advocate to be present on their side.  Together, we work as a team to level the playing field, to enforce their rights, and to make sure that no bounds are crossed during an ambush inspection.

 

With hundreds of mock agency inspections under my belt, I've learned a few things too:

Your Office Staff is an Extension of YOU:  While the responsibility of compliance falls on the practitioner, I have been surprised at the amount of office staff/staff members who were unfamiliar with proper policies and procedures.  Share this information with staff, and put them to work to help the cause.  Who's purging expired medications?  Who's running and logging sterilizers?  Who's in charge of updating policies and manuals?  It takes a village, people.  Also, I have heard staff members shouting the names of patients in ear shot of other patients (a HIPAA no-no) and be what I will call "less than professional" to people who call the office or to patients at the glass window.  It takes one unhappy patient to report the office to an agency.  Just one.

 

  1. Pharma Representatives Are Not Abiding by the New Law:  I cannot tell you how many extravagant catered lunches I have seen brought into my clients' medical practices by pharmaceutical reps who clearly do not adhere to the $15 per person regulated requirement.  From full expensive Italian food spreads, to fresh chopped salads with sliced filet mignon on top, to sparkling cider or Perrier abundantly flowing, there is a flagrant disregard for the new law (like it or hate it) and no education offered by the rep.  When present for these opportunities, I brazenly ask for the receipt, get a head count, do some quick math, and point out the problem.  Then I grab some lunch!

  2.  This Experience Certainly Has Not Gone Without Injuries: From slips and falls on spills, to dog bites (two to be exact), to inventory falling on my head, to drawers falling out on me, to stumbling off ladders and foot stools, to twisted ankles in parking lots, to scalpel cuts, I have pretty much run the gamut.

  3.  I am Honored and Humbled at the Opportunity to be Allowed to Literally & Figuratively Look at the Skeletons in Your Closets.  Some of the issues we have discussed have been sensitive in nature, and I appreciate the chance to consult and offer guidance on areas of vulnerability in your practices. Some of these issues involve practices investing in more machinery, instruments, and staff, which I recognize can pose a new financial burden on medical practices.  I have truly enjoyed when these inspections have morphed into a collaborative discussion about how to best suit the needs of the practice taking into account so many different areas of concern for a practitioner.  Someone recently nicknamed me "La Consigliere" because I come in and advise on everything.  I must admit, I kind of like that one.

  4. I Have Experienced Tremendous Empathy for Many Physicians: Most physicians are simply trying to follow state and federal regulations and have been surprised by all of the "extra" requirements that they are being held to.  Some of the discussions I have had during these inspections have been spirited in nature, while others were outright arguments.  It is extremely challenging to be in a position where I am offering advice to physicians based upon unofficial guidelines, especially when to achieve compliance will put a financial strain on the practice.  Many practitioners have become frustrated and have demanded that agencies put all requirements in writing so they can be followed.  The problem with this is once guidelines are memorialized in writing there is no room to challenge them, no wiggle room, and no "gray area" for me to protect you. The key takeaway from all of these experiences is that, working together, we can pretty much button up all areas of concern for a practice and face a surprise ambush together as a team.  Problems are better known and assessed, than ignored. I am happy to see that most practitioners share that mindset.  We are already starting to see that these proactive measures may actually be having a beneficial impact on the defensibility of agency claims against physicians and a decrease in the sheer number of claims.  I stand in your corner should the need ever arise.

  5. The Following Key Areas Are Being Assessed by Agency Inspectors During Surprise Inspections:
    • Expired medications, samples, creams, lotions, test tubes, OTC medications
    • Unmarked, open multi-dose vials
    • Non-compliant sharps containers and sharps disposal measures
    • Improper location of sharps containers
    • HIPAA violations
    • OSHA violations
    • Lack of employment policy & procedure manuals
    • Stark & Antikickback (State & Federal) violations
    • Non-compliant leases and subleases
    • Lack of equipment maintenance logs
    • Poor sterilization measures & policies
    • Prescription pad violations
    • X-ray machine violations and protocols
    • Unmarked alcohol/hydrogen peroxide/betadine dispensers or expired bottles of same
    • Sharp items in drawers readily accessible to patients
    • Hours not posted
    • Deficient patient sign-in sheets
    • Medical or biomedical items intermingled with foods
    • Uncleanliness & Clutter
    • Improper waste disposal or lack of documentation of same
    • Lack of appropriate and required policies

 

All it takes is one violation observed by one patient or one disgruntled former employee to ignite a fishing expedition as to all these areas during an ambush.The numbers are on the rise, and I have my suspicions as to why.In the past month, not only have I been called to intervene in an ambush of a client's office while mock inspecting another client's office, but also have had agency investigators ambush yet another client's office while I was mock inspecting it.You can't make these stories up.

 

Finding problems.  Creating solutions.  Taking on Goliath one practice at a time.  We fight together.

 

What a long strange trip it's been.

 

Gallagher Campanella LLC provides comprehensive legal solutions to clients in New Jersey, New York, and Pennsylvania

Attorneys Nan Gallagher and Gina Campanella

Nan Gallagher and Gina Campanella, are partners in thier full-service healthcare law firm, Gallagher Campanella LLC, with offices in Wyckoff and Morristown, New Jersey as well as in Manhattan.  They represent a broad spectrum of clients ranging from individual practitioners and medical practices to organized medical-dental staffs and societies. For more on Gallagher Campanella LLC, go to GCHealthLaw.com or e-mail them at nan@GCHealthLaw.com or gina@GCHealthLaw.com

 

© 2018 New Jersey Association of Osteopathic Physicians and Surgeons

The Journal is the official magazine of the New Jersey Association of Osteopathic Physicians and Surgeons (NJAOPS). NJAOPS is the sixth largest state affiliate of the American Osteopathic Association. NJAOPS represents the interests of more than 4,700 active osteopathic physicians, residents, interns and medical students. Founded in 1901, NJAOPS is one of the most active medical associations in New Jersey with 12 county societies.