Question: Did The Joint Commission issue a new FAQ regarding the use of non-licensed, non-employee individuals in a hospital, including health care industry representatives?

Yes.  The Joint Commission (“TJC”) issued the new FAQ yesterday.  The FAQ states that TJC has expectations regarding anyone entering a health care organization, and that to maintain patient safety, organizations need to be aware of who is entering, and their purpose.

The FAQ then states that there are additional expectations for non-licensed, non-employees that have a “direct impact on patient care” and uses as examples, health care industry representatives in operating rooms giving guidance to a surgeon, or training staff on equipment use, and surgical assistants brought in by surgeons, then lists these requirements and the Standards and Elements of Performance:

• Taking steps to ensure that patient rights are respected, including communication, dignity, personal privacy (RI.01.01.01, EPs 4, 5, and 7), and privacy of health information (IM.02.01.01, EPs 1 and 2);
• Obtaining informed consent in accordance with organization policy (RI.01.03.01, EPs 1, 2, and 13);
• Implementation of infection control precautions (IC.01.01.01, EP 1);
• Implementation of the patient safety program (LD.04.04.05, EP 1); and
• For non-employees brought into the organization by licensed independent practitioners, there are two additional requirements regarding qualifications and competence of these individuals (HR.01.02.05, EP 7 and HR.01.07.01, EP 5).  (This requirement does not apply to health care industry representatives as they are not under the direction of a licensed independent practitioner.)

The FAQ then notes that these are the minimum Standards, and that an organization may choose to apply other Standards, and/or more stringent requirements.  It concludes by stating that while TJC has received many questions regarding credentialing health care industry representatives, it does not require credentialing of these individuals, but that some professional organizations do recommend specific credentialing requirements for these individuals, and to check www.advamed.org for more information.

(From a Chief Medical Officer who recently attended The Peer Review Clinic)

Question: We are implementing the professional practice evaluation (peer review) process that we learned at The Peer Review Clinic.  I know that you recommend that a Leadership Council perform a “triage” function.  We are concerned that adding this step may slow down the process.  Why not just have the multi-specialty Professional Practice Evaluation Committee (PPEC) serve that function?

Answer:  Here are the reasons why we recommend (and most hospitals we work with include in their professional practice evaluation process) a Leadership Council

1. It keeps all of the top Medical Staff Leaders who serve on the Leadership Council – President of the Medical Staff, Chair of the PPEC, CMO/VPMA and perhaps Credentials Chair – in the loop with regard to the cases that are being reviewed in the process.  Certainly, reports from all Department Chairs regarding cases they have reviewed are sent to the PPEC for its review, but that happens on the “back end.”  Having the Leadership Council triage on the front end helps to prevent cases from going into a “black hole” in the Departments and makes sure that cases are reviewed according to the appropriate procedures (See #2 below).  Could the PPEC serve this function?  Yes, but it is harder to schedule a committee to review and make those initial triage determinations so using the PPEC for that function is likely to hamper rather than expedite the process.
2. Not all cases that are identified for review should go through the peer review process, e.g., cases involving unprofessional conduct or that might involve a practitioner health issue.  Many hospitals are using the Leadership Council to address cases of unprofessional behavior that are identified or referred into the process.  Incidents of unprofessional conduct (or to use the Joint Commission’s latest phrase, “behaviors that undermine a culture of safety”) are usually much better and more consistently addressed through a Medical Staff Code of Conduct Policy with a small group of leaders (such as those on the typical Leadership Council) than by Department Chairs alone or by the PPEC.  Likewise, issues involving a practitioner health issue should be addressed through the Practitioner Health Policy, not through the peer review process.

Some hospitals have all cases go to the Leadership Council for triage and referral to the appropriate review process.  Others have “straightforward” cases involving clinical issues go directly to Department Chairs for review and “administratively complex” cases go to Leadership Council.  The “administratively complex” cases are those involving professional conduct or a possible health issue, those involving the Department Chair, or those where a troubling clinical pattern has developed with a practitioner that has not been resolved through previous interventions.

Certainly, a Leadership Council is not absolutely required.  But most hospitals that have implemented it have found it to significantly enhance the effectiveness and efficiency of the process.

Upcoming dates for The Peer Review Clinic:

• October 4-6, 2012 • Fairmont Scottsdale Princess
• February 7-9, 2013 • Disney Boardwalk
• May 2-4, 2013 • Ritz-Carlton, New Orleans

Question:

Emergency Departments have been volatile places for a time now, so our hospital has had a policy on managing difficult ED patients for a while.  But now our staff is clamoring about disruptive inpatients and visitors, Security wants to post large “no weapons allowed” signs at all access points of the hospital, and searching patients and visitors has been raised.  What kind of policies are hospitals putting into place to try to manage all of this?  And just what the heck is going on?

Answer:

Patient violence and disruption are becoming increasingly common, and scary.  Violence (or the threat of it) has led hospitals to adopt no weapons policies, which include appropriate signage and the searching of patients and visitors, as needed, in the ED.  Disruptive patient policies are becoming more common.  (Disruptive patients are different from violent patients.  Disruptive patients are noncompliant as to hospital rules, respecting staff and personnel, and rules of civility.)   Disruptive family members of patients are not uncommon.  Hospitals have adopted policies concerning the taking of audio recordings, photographs or moving images by cell phone or other handheld devices to prevent visitors from taping the care of patients (for potential use against those providing the care).   In-service programs on defusing violence and/or escalating situations are often held in multiple hospital units, not simply the ED.  Outpatient clinics and practices are dealing with more disruptive patients and visitors.  Physicians are trying to deal with patients who are getting multiple medication prescriptions from multiple providers. (These patients often use multiple pharmacies to prevent discovery of their ruse.)   Physician “firings” of patients because of this behavior are on the rise.  So are firings due to patient noncompliant behavior.

The reasons for all this?  There are many:  enhanced levels of stress (high unemployment and depressed wages); mental instability issues (psychiatric and drug and alcohol-based); societal breakdowns in civil behavior; hospitals as prime spots for emotional distress, outbursts and confrontations; hospitals open 24 hours a day; the list goes on and on.  There is no easy answer to this, nor any one answer.  That’s why we are seeing hospitals adopting more behavioral policies of these kinds (and behavioral patient treatment contracts) to try to manage difficult situations in all parts of the hospital, and with all populations of the hospital.

Question:

Thanks for the clarification a couple of weeks ago on the recent CMS Memorandum (S&C-12-17) regarding providers writing orders for outpatient hospital services.  As a follow-up question, are we required to check excluded provider status or query the National Practitioner Data Bank (“Data Bank”) for these ordering practitioners who do not hold clinical privileges at our hospital?

Answer:

The CMS Memorandum does not specifically require a hospital to check excluded provider status or query the Data Bank for these practitioners.  However, a hospital is required to develop a policy that describes how it will handle these practitioners.

Even though not required by the CMS Memorandum, a hospital may want to check excluded provider status.  Many of the outpatient services these practitioners may order may be an item or service that is paid for in whole or in part by a federal health care program.  If the practitioner is excluded, the hospital would be subject to denial of payment and possible civil monetary penalties.

Since the ordering practitioners are not being granted clinical privileges, there is no requirement to query the Data Bank.  If a hospital decides that it does want a Data Bank report, it could require the practitioner to self-query.

QUESTION:

Can our hospital’s Institutional Review Board (“IRB”) be structured like and function as a medical staff committee?

ANSWER:

No.  The federal Food and Drug Administration regulations pertaining to IRBs, 21 C.F.R. §56.101 et seq., define an IRB as “any board, committee, or other group formally designated by an institution to review, to approve the initiation of and to conduct periodic review of biomedical research involving human subjects.”  The Department of Health and Human Services’ regulations echo the “institutional” aspect of the formal designation of IRBs (45 C.F.R. Part 46).  Federal regulations require the IRB to be a committee formally designated by a hospital’s Governing Board to review biomedical research involving human subjects at the hospital.

Therefore, we recommend that the IRB be created by a Board resolution and thereafter function as a committee of the hospital, rather than the medical staff, with its independent authority derived from the Board.  For this reason, a medical staff committee should not act as the IRB.  There may be substantial overlap of the IRB membership with those of a medical staff committee.  However, the IRB should be constituted as a separate committee of the Board in accordance with the membership requirements set forth in the federal regulations.

Question: Why does Horty Springer always schedule its audio conferences during clinic hours?  It is very difficult for a busy physician to carve out these blocks of time.  How about 11:30 or noon?

Answer: We get this question a lot, so we thought we’d take a minute to address it, as we have always struggled to find a time that works best for all.  The problem is that we serve physicians and hospitals in five different time zones!  This makes it difficult – if not impossible – for us to find a time that is convenient for all, or even most.

But don’t be discouraged!  We appreciate your interest in our programs and this is why we make all of our audio conferences available on CD and MP3.  This provides even the busiest professional the opportunity to listen at his or her convenience.

 

Check out our library of past titles on our new website (yes, we really do want to show it off!) or keep an eye out for upcoming audio conferences coming to an iPod near you!

Question:

Like most hospitals, we’re employing more and more physicians.  We’ve been struggling with how to conduct peer review of these employed physicians.  Should we use the Medical Staff peer review process, or should we address concerns via the employment contract using the Human Resources process?

Answer:

Many hospitals are struggling with this question.  Ideally, the Medical Staff and HR processes can be integrated to take advantage of the unique advantages of each.  It would be impossible to address this question fully in this limited space, but here are some general thoughts.

We recommend that once a concern about an employed physician is logged in to the hospital’s central repository (you do have a central repository, right?), the person or entity responsible for employment decisions be notified.  This may be a hospital-affiliated physician group, or it may be the HR department within the hospital.  (We’ll refer to this person or entity as the “employer.”)

The content of this notification has to take into account the state’s peer review law.  Some states permit the free flow of information among peer review entities, while other state laws do not address this topic.  Where it is not clear that state law permits the sharing of peer review information, one option is for the employer to be notified that a concern has been raised without providing copies of documentation.

Once the employer has been notified that a concern exists, it can choose to review the matter itself or it can ask that the matter be reviewed via the Medical Staff process.  Presumably, employers will be more likely to deal with behavioral concerns on their own, while they may be more likely to defer to the Medical Staff process to review clinical issues.

If the employer does review the matter on its own, it must notify the Medical Staff process of its resolution of an issue.  Importantly, if those responsible for the Medical Staff process are unhappy with the employer’s resolution of a concern, they have the authority to review the matter independently via the Medical Staff process.

If the employer asks the Medical Staff to review an issue, the employer can be kept in the loop by having the person responsible for employment decisions (or a designee) take part in the Medical Staff’s review of the issue (this may be the VPMA or the physician in charge of the hospital-affiliated group).  This is perhaps the safest approach to protect the peer review privilege, depending on state law.  If at any point during this process the employer concludes that the physician’s employment should be terminated, the employer may do so (subject to the procedures set forth in the employment contract).

There are numerous other factors that must be considered, such as whether the physician’s contract has an “incident and coterminous” provision, whether it has a “no cause” termination provision, whether litigation is likely if a physician is terminated, and so on.  But the key point is that it is possible to integrate and coordinate the Medical Staff and HR processes.

For more information on these issues, please join us in Chicago on April 12-14 for The Peer Review Clinic.  Mornings will be devoted to discussions of how hospitals can design a more effective peer review process, while afternoons are free to let you explore all the museums, parks and other attractions of Chicago. 

Question: We were confused by a recent CMS Transmittal that seems to indicate that all providers writing orders for hospital outpatient services (i.e, rehabilitation and respiratory care) must be privileged by the hospital. This requirement would create huge headaches for us and our patients. Can you clarify CMS’s position on this issue?

Answer:

This issue has been on the minds of many, ever since CMS published Transmittal 72 back in November.  It stated that certain hospital outpatient services could only be ordered by practitioners who had been granted clinical privileges to do so.

This set off a firestorm in the provider community.  Hospitals pointed out that Transmittal 72 created a huge problem for community physicians (i.e., those without hospital privileges) and for physicians whose patients travel out of town or, worse yet, out of state.

Fortunately, CMS issued a new memorandum on February 17, 2012 clarifying its position and updating its original guidance.  In the new memorandum, CMS makes it clear that outpatient services in hospitals may be ordered by a practitioner who is:

• responsible for the care of the patient;
• appropriately licensed;
• acting within his/her scope of practice under state law; and
• authorized by the medical staff to order the applicable outpatient services in accordance with hospital policy.

However, the practitioner is not required to hold medical staff privileges at the hospital under this new superseding guidance.

Did you notice the number of cases in this week’s HLE that involved employed physicians?  We did!  Join Linda Haddad, Henry Casale and Charlie Chulack to learn more – “Integrating Employed Physicians into the Health System of the Future,” April 12?14 at the Fairmont, Chicago.

Question: We heard that the Health Care Reform law has several provisions on malpractice reform. Have those provisions been implemented?

Answer: The Patient Protection and Affordable Care Act (“PPACA”) does contemplate malpractice reform. Section 10607 of the PPACA provides for $50,000,000 to be awarded to states to develop and implement malpractice demonstrations. The demonstrations were meant to be alternatives to current tort litigation models and were to include both promotion of a reduction in medical errors and resolution of malpractice disputes. However, the distribution of these awards has been stalled by Congress’s unwillingness to fund the malpractice demonstrations. Nonetheless, some states have begun experimenting with malpractice reform. For example, Oregon is considering developing “safe harbor” legislation that would limit liability for those physicians who follow state-endorsed, evidence-based guidelines. Oregon is also studying the effects of defensive medicine and overutilization. Hospitals and health care systems are also testing ideas to reduce malpractice claims and amounts, such as the University of Michigan Health System’s disclosure program that found that there were fewer lawsuits and claims after the program was implemented. To find out more on this topic, please join Linda Haddad, Ian Donaldson and Charlie Chulack for the audio conference “Be Careful What You Ask for: Tort Reform and Malpractice Litigation” on Tuesday, March 6, 2012 from 1:00 p.m. – 2:00 p.m. Eastern Time.

Question: Our hospital recently became part of a multi-health care system. The Chief Medical Officer of the System announced, at a recent Medical Executive Committee meeting, that one of the System’s top priorities was to standardize the medical staff bylaws and related policies. We’re not sure what this will mean to us or what role, if any, we will get to play in the process. Can you help us?

Answer: Many health care systems are recognizing the importance of having similar bylaws, policies and procedures throughout their organization. The standardization makes it easier for physicians who want to move from one hospital in the System to another. If they meet the standards for appointment and privileges at one hospital, they will meet the standard at the other hospitals in the System. And, there won’t be new policies or procedures to learn as they move from one system facility to the next. This benefit also extends to the System’s Chief Medical Officer and legal counsel who, with standardization, will not be forced to follow completely different policies for similar situations that occur in the different hospitals.

Having the same or similar bylaws, policies and procedures has the added benefit of ensuring or at least facilitating similar outcomes with respect to credentialing and privileging decisions. Different standards, without a rational basis, could be hard to explain in a legal challenge brought by a physician who was appointed to one system hospital and rejected at another or by an injured patient in a malpractice claim.

For most medical staffs, living through a hospital merger, consolidation, or acquisition can be a bit unsettling. There are often lots of questions about the new organization, including how it will function, how much will change, and the role physicians will play in it.

Resisting the change (including trying to hold on to past bylaws, policies, and procedures) is probably not the most productive approach. It would be better to make sure that physician leaders from your organization play a role in the transition. Make sure you attend meetings that are scheduled to discuss the transition and that you read newsletters and other information published about the transition. It would also be a great idea to volunteer to serve on key transition committees, like the Bylaws Task Force.

Try to maintain an open mind during the transition and be willing to bend. And keep your eye on the issues that are really important.