choosing the correct corrective action - namss

Choosing the Correct Corrective Action

Session Code: TU16

Date: Tuesday, October 24

Time: 2:30 p.m. - 4:00 p.m.

Total CE Credits: 1.5

Presenter(s): Timothy Adelman, JD

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Presented By:Tim Adelman

[email protected](410) 224-3000

Agenda• Understanding Corrective Action v. normal Peer Review

• Understanding the purpose of Corrective Action

• Overview of the Legal Framework impacting the implementation of

Corrective Action

• Best practices for choosing an effective Corrective Action

Corrective Action v. Peer Review

Peer Review may refer to an entire process that includes routine reviews, focused reviews, investigation and corrective action.

Corrective Action is a specific action imposed on a practitioner to address substandard conduct. Corrective Action

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Peer Review

Examples of Peer Review

» Review of Quality Reports submitted by individuals

» Review of quality data (length of stay, blood loss, return to OR, etc.) to assess a practitioner’s performance.

» Review of complains by patients relating to care and treatment.

» Imposition of an FPPE4

Peer Review - FPPEFocused Professional Practice Evaluation

» FPPE is a “process whereby the organization evaluates the privilege-specific competence of the practitioner who does not have documented evidence of competently performing the request privileges” or may also be used “when a question arises regarding a currently privileged practitioner’s ability to provide safe, high quality patient care.” TJC MS.08.01.01

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Peer Review - FPPE• TJC: MS.08.01.01 Only Has 9 Elements of Performance:

– Period of evaluation for all initially requested

– OMS develops criteria for evaluating performance when care issues are identified

– Monitoring process includes:

• Criteria for monitoring, method for establishing monitoring plan specific to privilege, method for determining during and circumstances under external monitoring are required

– Consistently implemented

– Triggers are clearly defined

– Decision to monitor is based on current clinical competence, practice behavior and ability to perform privilege

– Criteria are developed that determine type of monitoring

– Measures employed to resolve performance issues are clearly defined

– Measures employed to resolve performance issues are consistently implemented

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3

Peer Review - FPPEFPPE is:

» a process to evaluate a practitioner’s performance.

FPPE is not:

» a corrective action but may include reportable actions, i.e. the requirement to have a proctor present for all surgical procedures.

"A good FPPE process allows a medical staff to bridge the gap between having no firsthand knowledge of a practitioner's competency to one in which we have sufficient information to allow monitoring of ongoing competency through the peer review process." - HealthleadersMedia, 2015

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Peer Review - FPPE

Examples of FPPE for cause:

» Chart review of next 10 cases

» Use of a proctor to evaluate performance in the Operating Room

» Interviews of Operating Room personnel to evaluate the practitioner’s conduct

» Interviews of staff to determine whether ongoing reachability issues

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Peer Review - FPPE

Examples of what is NOT a FPPE for cause:

» Mandating that a practitioner have no further complaints about reachability

» Removal from Emergency Department On-Call Roster

» Requirement to use surgical first assistant for all procedures.

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4

Peer Review - FPPESo FPPE is Done, Now What?

• Preferred: Convert to established OPPE process with no identified or actionable concerns

• Possible: Continuation or extended duration to validate or resolve concerns

• Possible: Modification of privileges, additional education or training

• Possible: Corrective action

Corrective ActionExamples of Corrective Action

» Requirement to have a proctor physical present for the next 10 surgical procedures

» Removal from ED on-call roster» Summary Suspension» Letters of reprimand» Termination of clinical privileges» Requirements to attend CME» Requirement to obtain a Physical/Mental

Health Evaluation

Reporting Obligations for Corrective Action

HCQIA

State Reporting Obligations

Hospital’s Response to Future Questions

Applicant’s Response to Future Questions

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Health Care Quality Improvement Act

HCQIA provides immunity for Professional Review Actions:

» “Action or recommendation of a professional review body . . . Which is based on the competence or professional conduct of an individual physician.” 42 U.S.C. 11151(9)


HCQIA - “Professional review action” means an action or recommendation of a professional review body which is taken or made in the conduct of professional review activity, which is based on the competence or professional conduct of an individual physician (which conduct affects or could affect adversely the health or welfare of a patient or patients), and which affects (or may affect) adversely the clinical privileges of the physician.


Standards for Immunity under HCQIA» Reasonable belief action in furtherance of quality

healthcare» Reasonable effort to obtain the facts» Adequate notice and hearing procedures» Reasonable belief that action warranted by facts

Rebuttable presumption that immunity standards have been met

Must be overcome by preponderance of the evidence

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NPDB Reporting Obligations Denial of reappointment to hospital medical staff

» Report if MEC determines denial relates to professional competence or conduct that could adversely affect patient welfare

Denial of application by hospital governing body» Report if a result of a professional review action & related to professional competence

Summary Suspension for more than 30 days» Report if based on professional competence/conduct, and a result of a professional review action

Restriction on clinical privileges for more than 30 days» Report if result of professional review action based on professional competence/conduct leading

to the inability to exercise independent judgment

Termination of Privileges (distinct from termination of employment)» Report if a result of a professional review action & related to professional competence/conduct

Withdrawal while under investigation or to avoid investigation» Report

NPDB Reporting Obligations

Walker v. Memorial Health System of East Texas, (2/8/2017) Hospital imposed proctoring requirement for surgeon’s next five cases

In practice, the requirement remained in place for 30+ days

Hospital made a NPDB report stating it imposed a proctoring requirement that lasted longer than 30 days

Surgeon sought preliminary injunction requiring hospital’s submission of void report *also alleged business disparagement, tortious interference with contract, and racial discrimination

NPDB Reporting ObligationsWalker v. Memorial Health System of East Texas, (2/8/2017)

U.S. District Court judge granted preliminary injunction requiring hospital to submit void report

Proctoring requirement was not imposed for more than 30 days, therefore not reportable

“Although the hospital was aware of the reporting requirements (including the 30-day requirement)…it nevertheless decided to adopt a proctoring requirement that is silent as to duration.”

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NPDB Reporting ObligationsTakeaways from Walker

Restrictions on clinical privileges without a specific duration may not be reportable to NPDB

» examples: proctoring requirement for X cases; mandatory pre-procedure consults for certain types of cases; CME requirement before performing a future procedure

Summary suspensions versus clinical privileges

Courts give deference to NPDB Guidebook


May be a requirement for the Hospital or licensed providers to report certain corrective actions.

State reporting obligations may exist when a NPDB reporting obligation does not

Typically there is immunity for making reports

Need to verify peer review privilege to ensure only appropriate information is disclosed.


Example: Colorado Statutory Requirement (§ 25-3-107)

Mandatory to report any disciplinary action to:» suspend, » revoke, or » otherwise limit

the privileges of a licensed physician or podiatrist that is taken by a hospital governing board .

to the Colorado Medical Board or the Colorado Podiatry Board in the form prescribed by the appropriate Board.

The hospital must provide additional information as is “deemed necessary” by the Colorado medical board or the Colorado podiatry board to conduct a further investigation and hearing.

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Other Reporting Obligations

Some states may require a hospitals may have to respond to inquire for privilege verification.

If you do respond to privilege verification, make sure it is accurate. Kadlec Medical Center v. Lakeview Anesthesia Associates, 527

F.3d 412, 2008 U.S. App. LEXIS 10267 (5th Cir. La. 2008)

Practitioner may have to answer on applications for licensure or privileges about restrictions, limitations, suspension, or termination of privileges.

The risk of failing to take Corrective Action

“The evidence reveals that the instances of [Dr.] Albaghdadi’s abusive treatment of women were greater in number and severity than those involving men.”

“The evidence also suggests that the hospital was aware of Albaghdadi’s treatment of Kopp and others.”

Kopp v. Samaritan Health System

13 F.2d 264 (8th Cir., 1993)


Nieto v. Kapoor, 268 F.3d 1208 (10th Cir., 2001)

“Dr. Kapoor’s behavior – which led at least six people to leave the ENMMC, some to leave the state, and some of the profession of nursing altogether – affected not only the patients,, plaintiffs, and other employees of the Eastern New Mexico Medical Center, it arguably impacted the overall public health.”

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Nieto v. Kapoor, 268 F.3d 1208 (10th Cir., 2001)

Compensatory Damages - $1,875,000

Punitive Damages - $1,875,000


In re Peer Review Action

749 N.W. 2d 822 (Minn, 2008)

“Hospital repeatedly acted in manners contrary to its established safeguarding policies; it treated Physician differently from others who had been subjected to peer review; and it imposed a harshly public punishment against Physician without first attempting a less-extreme intervention.”


In re Peer Review Action

749 N.W. 2d 822 (Minn, 2008)

“The factual findings made by the district court are sufficient to support the conclusion that Hospital engaged in ‘the intentional doing of a wrongful act’ or ‘the willful violation of a known right’”.

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Legal Protections when taking Corrective Action

Case law upholding immunity

Cohlmia v. Cardiovascular Surgical Specialists2012 U.S. App. LEXIS 18877 (10th Cir., 2012)

Summers v. Ardent Health Services150 N.M. 123, 257 P.3d 943 (2011)

Couch v. Board of Trustees of the Memorial Hospital of Carbon County

587 F.3d 1223 (10th Cir., 2009)


Example - Rude or Aggressive Surgeon Phase 1 - Informal meeting with the physician to discuss

the behavior - not reportable Phase 2 - Issuing a letter of reprimand - not reportable Phase 3 - Implementation of an FPPE - not reportable Phase 4 - Require the practitioner to undergo a mental

health evaluation, anger management course, or other behavior modification program - not reportable


Example - Rude or Aggressive Surgeon Phase 5 - Imposition of a suspension not longer than 14

days to allow for an investigation into the conduct. - not reportable to NPDB but maybe to State

Phase 6 - Imposition of summary suspension while further corrective action is considered- reportable to NPDB if longer than 30 days and likely reportable to the State

Phase 7 – Termination of Clinical Privileges – Reportable

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Example – Impaired Physician due to suspect substance abuse. Phase 1 - Require the physician to be tested for substances - not

reportable to NPDB but suspected impairment may be reportable to the State

Phase 2 - The physician may take a medical leave of absence to address the concern - not reportable to NPDB but suspected impairment may be reportable to the State

Phase 3 - Require the practitioner to undergo a substance abuse or mental health evaluation - not reportable to NPDB but suspected impairment may be reportable to the State


Example – Impaired Physician due to suspect substance abuse.

Phase 4 – 14 day precautionary suspension to investigate - not reportable to NPDB but may be reportable to the State

Phase 5 - Imposition of summary suspension while further corrective action is considered- reportable to NPDB if suspension is longer than 30 days and likely reportable to the State

Phase 6 - Termination of Clinical Privileges – Reportable


Example – Impaired Physician due to mental or physical condition. Phase 1 - Informal meeting with the physician to discuss the

behavior - not reportable Phase 2 - Require the practitioner to undergo a mental health

evaluation or skills assessment evaluation. - not reportable Phase 3 - The physician may take a medical leave of absence while

the physician undergoes evaluation or treatment for the impairment - not reportable to NPDB but health concern impacting clinical care may be reportable to the State

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Example – Impaired Physician due to mental or physical condition. Phase 4 - Imposition of an FPPE that incudes proctoring or observing the

physician for a specific number of cases over a period of time or number of cases - Reportable to the NPDB if mandatory to have a proctor and imposed for more than 30 days and may be reportable to the State

Phase 5 – Imposition of 14 day suspension pending evaluation/investigation - not reportable to NPDB but may be to the State.




Example – The physician has a significant bad outcome in treatment a patient. Phase 1 - Informal meeting with the physician to

discuss the performance - not reportable Phase 2 - Imposition of an FPPE that focuses on chart

review as the means of evaluation - not reportable Phase 3 - Require the practitioner to undergo a

mental health evaluation or skills assessment evaluation - not reportable


Example – The physician has a significant bad outcome in treatment a patient. Phase 4 - physician may take a leave of absence while the

physician undergoes skills training - not reportable Phase 5 - Imposition of an FPPE that incudes proctoring or

observing the physician for a specific number of cases over a period of time or number of cases - Reportable to the NPDB if mandatory to have a proctor and imposed for more than 30 days and may be reportable to the State

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Example – The physician has a significant bad outcome in treatment a patient. Phase 6 – Imposition of 14 day suspension pending

evaluation/investigation - not reportable to NPDB but may be to the State.



Additional Corrective Actions to Consider

Asking a physician to voluntarily refrain from exercising privileges for a period of time

» The NPDB would likely consider this to be reportable. However, if the physician volunteers, without being asked, then this may not be reportable to the NPDB.

Requiring a second opinion before procedures» If there is not requirement for a concurring second opinion, then not

reportable.

Limitation to the number of patient encounters in a day » This is likely not reportable to the NPDB as this is not a restriction on

privileges but a limitation on volume. However, there is no clear guidance from NPDB as to how they would interpret the reporting obligation

Outside Resources for Corrective Actions

Comprehensive Physician Evaluation Programs» Physician Renewal Center» Vanderbilt Center for Professional Health» UC San Diego Physician Assessment and Clinical Education Program

Continuing Medical Education Programs» Require physician to obtain approval in advance for a CME program» Review the materials in advance approving the program to make

sure it is appropriate» Ensure there is adequate documentation to ensure the program

was completed.

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Outside Resources for Corrective Actions

Independent Physical or Mental Health Assessment» Ensure evaluator is approved in advance by Medical Staff Leader(s)» Ensure physician is required to execute any authorization necessary for the

evaluator to speak to the Medical Staff Leader(s)» Ensure evaluator is aware of the issues/concerns so a proper assessment can be

completed» Require physician to follow through with any ongoing treatment recommendations

Proctors» Consider whether you require physician to arrange for and pay for the cost of a

proctor» Ensure proctor has appropriate clinical privileges at the Hospital» Require the proctor to prepare a written evaluation following each case or at the

conclusion of a series of cases.» Assess who is covering the proctor’s liability in performing the role of proctor.

Concepts to Remember

Do not confuse FPPE with Corrective Action

Prefer to use escalating Corrective Action

Tailor Corrective Action to the specific substandard conduct to be addressed

Ensure you understand both NPDB and State reporting obligations

Ensure consistency between Medical Staff Bylaws, Rules, Regulations & Policies

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Questions?

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Description of Conduct Proposed Corrective Action Reporting Obligations

Surgeon is rude and aggressive

with Hospital staff while

preparing for or performing

surgery. Conduct may include

yelling at staff, throwing

instruments or other materials,

saying demeaning comments to

staff.

Informal meeting with the physician to

discuss the behavior. The discussion

should focus on identifying the

improper conduct, asking the

physician how he/she anticipates avoid

such conduct in the future, and

providing clear expectations moving

forward.

While this meeting is informal, a

report of the meeting should be

documented for the physician

credentials/peer review file.

This is not reportable to the NPDB

and likely not report to state

licensing agencies unless the state

has a specific required report for

disruptive conduct.

Issuing a letter of reprimand

identifying the specific conduct that is

unacceptable (reference policy and

bylaw provisions if applicable) and a

warning that further conduct may

result in the initiation of formal

corrective action.





disruptive conduct.

Implementation of an FPPE with the

purpose of focusing on professional

conduct. This would involve

interviewing staff on a periodic basis

to determine whether the physician is

acting appropriate. The physician

should be notified in advance of the

FPPE.





disruptive conduct. However, this

could be interpreted as an

"investigation" such that a

resignation or failing to reapply for

clinical privileges during this FPPE

could require a report to the NPDB

and/or state licensing agency.

Require the practitioner to undergo a

mental health evaluation, anger

management course, or other behavior

modification program. You may

permit the practitioner to select the

course but any course should be

approved in advance by a hospital or

medical staff leader. It is

recommended that the practitioner be

required to authorize a representative

of the Hospital or medical staff obtain

the findings, results and

recommendation of any such

evaluation or program.












If the conduct was egregious,

imposition of a suspension not longer

than 14 days to allow for an

investigation into the conduct.

Following the investigation, action

should be taken to (1) further evaluate

the physician's performance; (2)


but may be report to state licensing

agencies. The practitioner would

be considered under an


resignation while under this

suspension would require a report

impose corrective action; or (3) close

the matter.

to the NPDB and/or state licensing

agency. If the conduct is egregious or

repetitive and the conduct may result

in an imminent danger to the health of

any individuali, imposition of

summary suspension while further

corrective action is considered.

If the suspension is not longer than

30 days, this is not reportable to

the NPDB but may be report to

state licensing agencies. If the

suspension is longer than 30 days,

then it is reportable to the NPDB

and likely the state licensing

agency.

If the conduct is egregious or

excessively repetitive, a

recommendation to terminate or not

renew clinical privileges. Remember,

unless the physician is also summarily

suspended, the physician may continue

to exercise their clinical privileges

until they have exhausted their due

process rights under the Medical Staff

Bylaws.

Termination of clinical privileges is

reportable once the action is final,

i.e. the governing body has upheld

the recommendation and

hearing/appeal rights are exhausted.


The physician appears impaired

due to suspect substance abuse.

If permitted by the Medical Staff

Bylaws, Rules, Regulations or

policies, immediately require the

physician to be tested for substances.

If the results are positive, review the

results with the physician during an

informal meeting and recommend the

physician enroll in the state physician

health program.

Suspected impairment while

practicing medicine is typically

reportable to state licensing

agencies by Hospital and maybe by

physicians individually. Some

states do not require a report by the

Hospital if the physician self-refers

to the physician health program.


unless there is an associated

professional review action that last

longer than 30 days.

If the physician test positive for

substance or admits to substance abuse

while treating patients or on-call, the

physician may take a medical leave of

absence to address the concern. It is

recommended that the Medical Staff

Bylaws prohibit returning from a

medical leave of absence until

approved by the medical staff leaders

or hospital administrator.

Suspected impairment while

practicing medicine is typically

reportable to state licensing

agencies by Hospital and maybe by

physicians individually. Some

states do not require a report by the

Hospital if the physician self-refers

to the physician health program.


unless there is an associated

professional review action that last

longer than 30 days.


substance abuse or mental health

evaluation. You may permit the

practitioner to select the course but

any course should be approved in

advance by a hospital or medical staff

leader. It is recommended that the

practitioner be required to authorize a

representative of the Hospital or










medical staff obtain the findings,

results and recommendation of any

such evaluation or program.



If the facility is concerned that the

practitioner is not safe to practice

while the substance abuse or mental

health evaluation is being performed, a

suspension may be imposed not longer

than 14 days to allow for evaluation

and investigation into the conduct.



agencies due to suspected

impairment while treating patients

or due to the length of a suspension.

The practitioner would be

considered under an "investigation"

such that a resignation while under

this suspension would require a

report to the NPDB and/or state

licensing agency. If the impairment is egregious,

imposition of summary suspension

while further corrective action is

considered.








agency.

If the conduct is egregious, a

recommendation to terminate or not

renew clinical privileges. Remember,

unless the physician is also summarily





Bylaws.







The physician appears impaired

due to mental or physical

limitations. This may include

the aging practitioner who

appears to have reduction in

his/her clinical or cognitive skill.

Mandating a physical/mental

evaluation or skills assessment

based solely on age may be a

violation of the ADA/ADEA.

There must be some associated

(observed) conduct that indicates

an impairment.


discuss the concerns. The discussion

should focus on identifying the

concerned conduct, methods to reduce

the effect of the impaired due to

mental or physical limitations (such as

using a surgical 1st assistance or

voluntarily relinquishing privileges for

certain procedures).









concerns of provider impairment.


mental health evaluation or skills

assessment evaluation. You may


evaluator or assessment course but the

evaluator or assessment course should

be approved in advance by a hospital

or medical staff leader. It is







However, this could be interpreted

as an "investigation" such that a



of the Hospital or medical staff to

obtain the findings, results and


evaluation or assessment course.




The physician may take a medical

leave of absence while the physician

undergoes evaluation or treatment for

the impairment. It is recommended

that the Medical Staff Bylaws prohibit

returning from a medical leave of

absence until approved by the medical

staff leaders or hospital administrator.

This is not reportable to the

NPDB. It may be reportable to a

state licensing agency if report for

impairment is required.

Imposition of an FPPE that incudes

proctoring or observing the physician

for a specific number of cases over a

period of time or number of cases. For

example, the physician must be

observed 10 times over the next 30

cases or 30 days.



licensing agencies as the FPPE but

do not restrict the privileges as

there is not a specific mandate to

have a proctor/observe for a

specific patient encounter.







Imposition of an FPPE that requires a

proctor or observer for a specific

number of cases or time period. For

example, the physician must have a

proctor or observe present for the next

10 cases or for each patient encounter

over the next 30 days.

The difference between this action and

the one above is that the physician

cannot perform a specific procedure

without a proctor or observer present.

This is reportable to the NPDB if

the restriction is imposed for more

than 30 days and may also be

reportable to the state licensing

agencies.

If the proctoring/observer

requirement can be completed

within 30 days, then it would not be

reportable to the NPDB.

This could be interpreted as an








while the mental health evaluation or

skills assessment is being performed, a














licensing agency.

If it is believed that the impairment

may result in an imminent danger to

the health of any individual,


while further evaluation or corrective

action is considered.








agency.

If the impairment is significant, the

medical may make a recommendation

to terminate or not renew clinical

privileges. Remember, unless the

physician is also summarily





Bylaws.







The physician has a significant

bad outcome in treatment a

patient. For example, the

physician perforates the colon

during a procedure, does not

recognize the perforation, fails

to appreciate the cause of the

patient's demise in the days

following the procedure and the

patient suffers physical harm.


discuss the clinical performance. The

discussion should focus on identifying

concerns with the clinical

performance, asking the physician how

he/she anticipates address the clinical

concerns, and providing clear

expectations moving forward.







licensing agencies.

Imposition of an FPPE that focuses on

chart review as the means of

evaluation. This may include a

retrospective review of patient charts

and may require the physician to

provide access to their office charts to

further evaluate the patient care.



licensing agencies.








mental health evaluation or skills

assessment evaluation. You may


evaluator or assessment course but the

evaluator or assessment course should

be approved in advance by a hospital

or medical staff leader. It is



of the Hospital or medical staff to

obtain the findings, results and


evaluation or assessment course.












The physician may take a leave of

absence while the physician undergoes

skills training. It is recommended that

the Medical Staff Bylaws prohibit

returning from a leave of absence until

approved by the medical staff leaders

or hospital administrator.

This is not reportable to the

NPDB. It may be reportable to a

state licensing agency.

Imposition of an FPPE that incudes

proctoring or observing the physician a

specific number of times over a period

of time or number of cases. For

example, the physician must be

observed 10 times over the next 30

cases or 30 days.



licensing agencies as the FPPE but

do not restrict the privileges as

there is not a specific mandate to

have a proctor/observe for a

specific patient encounter.







Imposition of an FPPE that requires a

proctor or observer for a specific

number of cases or time period. For

example, the physician must have a

proctor or observe present for the next

10 cases or for each patient encounter

over the next 30 days.

The difference between this action and

the one above is that the physician

cannot perform a specific procedure

without a proctor or observer present.

This is reportable to the NPDB if

the restriction is imposed for more

than 30 days and may also be

reportable to the state licensing

agencies.

If the proctoring/observer

requirement can be completed

within 30 days, then it would not be

reportable to the NPDB.

This could be interpreted as an








while the mental health evaluation or

skills assessment is being performed, a














licensing agency. If it is believed that the impairment

may result in an imminent danger to

the health of any individual,


while further evaluation or corrective

action is considered.








agency.

If the impairment is significant, the

medical may make a recommendation

to terminate or not renew clinical

privileges. Remember, unless the

physician is also summarily





Bylaws.






i See The Joint Commission Sentinel Event Alert, Issue 40: Behaviors that undermine a culture of safety, July 9,

2008.

choosing the correct corrective action - namss

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