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• “Given the flexibility provided for in the revised standard, a limited amount of revision is all that may be needed. In some cases, no revisions may be required.”– Frequently Asked Questions Regarding Standard
Every requirement set forth in Elements of Performance 12 through 36 must be in the medical staff bylaws. These requirements may have associated details, some of which may be extensive; such details may reside in the medical staff bylaws, rules and regulations, or policies. The organized medical staff adopts what constitutes the associated details, where they reside, and whether their adoption can be delegated. Adoption of associated details that reside in medical staff bylaws cannot be delegated. For those Elements of Performance 12 through 36 that require a process, the medical staff bylaws include at a minimum the basic steps, as determined by the organized medical staff and approved by the governing body, required for implementation of the requirement. The organized medical staff submits its proposals to the governing body for action. Proposals become effective only upon governing body approval. (See the Leadership chapter for requirements regarding the governing body’s authority and conflict management processes.)
• Medical staff bylaws must contain “every requirement” set forth in Elements of Performance 12 through 36, but only a basic framework, not all the details. Use EP’s 12 - 36 as a checklist against existing medical staff bylaws.
• For EP’s that require a process, the medical staff bylaws need only contain the basic steps required for implementation.
• The details do not have to appear in the medical staff bylaws.
• The details can be placed in freestanding policies, rules or regulations.
• EP 3 says that the details may reside in the medical staff bylaws, rules and regulations, or policies. Does it really make a difference where the organized medical staff (OMS) puts the details, as between the bylaws, the rules and regulations, or the policies?
• It can make a difference in the process for changing the details, and, accordingly, in the ease or lack thereof associated with amendments.
• Remember that the medical staff bylaws can only be amended by the voting members of the OMS, so if the details are in the bylaws a vote of OMS is required
• As between rules and regulations on the one hand and policies on the other, assume that the OMS has delegated to the Medical Executive Committee the authority to change the details. Look at EP 9.
If the voting members of the organized medical staff propose to adopt a rule, regulation, or policy, or an amendment thereto, they first communicate the proposal to the medical executive committee. If the medical executive committee proposes to adopt a rule or regulation, or an amendment thereto, it first communicates the proposal to the medical staff; when it adopts a policy or an amendment thereto, it communicates this to the medical staff. This Element of Performance applies only when the organized medical staff, with the approval of the governing body, has delegated authority over such rules, regulations, or policies to the medical executive committee.
• MS.01.01.01 can put the governing body (e.g., the hospital’s board of trustees) in a no-win situation.
• For example, suppose applicable law is amended, and an amendment to medical staff bylaws, rules or regulations is required in order to comply with the law as amended. (EP 4 provides that the medical staff bylaws, rules and regulations, and policies, the governing body bylaws, and the hospital policies must be compatible with each other and compliant with law.)
• If the organized medical staff (OMS) won’t agree to the change, the governing body is stuck, because only the OMS “adopts and amends” medical staff bylaws, subject to governing body approval (under EP 2).
• Members of the governing body have fiduciary duties (often articulated as a duty of care, a duty of loyalty, and a duty of obedience) that, if breached, can result in individual liability
In cases of a documented need for an urgent amendment to rules and regulations necessary to comply with law or regulation, there is a process by which the medical executive committee, if delegated to do so by the voting members of the organized medical staff, may provisionally adopt and the governing body may provisionally approve an urgent amendment without prior notification of the medical staff. In such cases, the medical staff will be immediately notified by the medical executive committee. The medical staff has the opportunity for retrospective review of and comment on the provisional amendment. If there is no conflict between the organized medical staff and the medical executive committee, the provisional amendment stands. If there is conflict over the provisional amendment, the process for resolving conflict between the organized medical staff and the medical executive committee is implemented. If necessary, a revised amendment is then submitted to the governing body for action.
• No. EP 11 allows for a process, where there is a need for an “urgent amendment” to the organization’s “rules and regulations,” in which the Medical Executive Committee can speak for the OMS (if the OMS has delegated that authority), and can provisionally adopt rules and regulations that comply with the law as amended, and, if it does so, the governing body may provisionally approve an urgent amendment.
• Neither EP 11 nor any other EP allows unilateral action by the governing body in amending the medical staff bylaws, or the medical staff rules and regulations.
• According to The Joint Commission, the answer lies in communication, collaboration and conflict resolution, by and among the governing body, the Medical Executive Committee, and the Organized Medical Staff.
• Improving Quality of Care • Protecting Participants with Immunity and Confidentiality • Minimizing Claims (from both physician and patient)• Meeting Joint Commission Requirements
• Failure to follow controlling authority in (1) – (4) can put hospitals in a cross-fire from three directions – Patients – Members of the Medical Staff – Joint Commission
• Horns of the Dilemma – Get sued by the patient, if you fail to take corrective
action against the bylaws – Get sued by the MD, if you do take corrective action
• How does a hospital "monitor and oversee" physician care? Through its Medical Staff by – Credentialing– Recredentialing– Performance Improvement– Peer Review– Corrective Action/Professional Review
• If a professional review action meets all the standards specified in section 11112(a) of HCQIA, no person shall not be liable in damages under any law
• What must a hospital do to bring itself within the safe harbor of HCQIA?
• 42 U.S.C. § 11112(a).For purposes of immunity, a professional review action must be taken(1) in the reasonable belief that the action was in the
furtherance of quality health care (2) after a reasonable effort to obtain the facts of the matter (3) after adequate notice and hearing procedures are
afforded to the physician involved (4) in the reasonable belief that the action was warranted by
the facts known after such reasonable effort to obtain facts and after meeting the requirement of paragraph (3)
• Summary: Adhere to (1)-(4) and immunity attaches to the proceedings
• A professional review action shall be presumed to have met the preceding standards necessary for immunity unless the presumption is rebutted by a preponderance of the evidence
• The Statute puts the B/P on the person/entity who seeks to attack the recommendations sought to be enforced
• The lesson here: The law does not place the B/P on the Hospital (although the Hospital, through bylaws, hearing plan, etc. can place the burden on itself)
• B/P is NOT on the hospital to show clinical deficiencies, disruptive behavior or anything else
• Many hearings turn on the question of who has the B/P
• Bylaws usually answer the question
Example #1: B/P is on hospital to prove by a preponderance of the evidence
Example #2: B/P is on practitioner to prove by clear and convincing evidence that the hospital's decision was arbitrary, unreasonable, or not supported by the evidence
• A health care entity is deemed to have met the adequate notice and hearing requirement of HCQIA if the following conditions are met or waived – The physician has been given notice stating:
• that a professional review action has been proposed
• the reasons for the proposed action • the physician has the right to request a hearing • the physician's rights at the hearing
Practitioner Rights At The Hearing• An impartial “decider” is:
– a mutually acceptable" arbitrator – a hearing officer appointed by the entity – a panel not in "direct economic competition”
• Representation by an attorney • To have a record made of the proceedings (but must pay for his/her
own copy) • To call, examine, and cross-examine witnesses • To present evidence determined to be relevant by the hearing
officer, regardless of its admissibility in a court of law • To submit a written statement at the close of the hearing • To receive the written recommendation of the panel, including a
statement of the basis for the recommendations • To receive a written decision of the health care entity, including a
• If suspension/restriction of clinical privileges is less than 14 days, during which an investigation is being conducted, OR
• In the case of summary suspension, where the failure to act "may result in an imminent danger to the health of any individual" – Practitioner may be suspended, with hearing to come
Joint Commission: Elements Of Performance For MS 01.01.01 Which Are Related To Corrective Action• EP 28
– Indications for automatic suspension of a practitioner's MS membership or clinical privileges • EP 29
– Indications for summary suspension of a practitioner's MS membership or clinical privileges • EP 30
– Indications for recommending termination or suspension of medical staff membership, and/or termination, suspension, or reduction of clinical privileges
• EP 31– The process for automatic suspension of a practitioner's medical staff membership or clinical
privileges • EP 32
– The process for summary suspension of a practitioner's medical staff membership or clinical privileges
• EP 33– The process for recommending termination or suspension of medical staff membership,
and/or termination, suspension, or reduction of clinical privileges • EP 34
– The fair hearing and appeal process, which at a minimum shall include • The process for scheduling hearings and appeals • The process for conducting hearings and appeals
• EP 35– The composition of the fair hearing committee
• There are mechanisms including a fair hearing and appeal process for addressing adverse decisions regarding reappointment, denial, reduction, suspension, or revocation of privileges that may relate to quality of care, treatment, and services issues
• Designed to allow the practitioner the opportunity to:– Defend himself/herself before an impartial panel – Appeal any adverse decision to the GB
• The MS implements a process to identify and manage matters of individual health for licensed independent practitioners which is separate from actions taken for disciplinary purposes
• Duty to provided education regarding impairing conditions
• Goal is to optimize professional functioning consistent with protection of the Patient
• Bylaw provisions should comply with Joint Commission requirements relating to fair hearing and corrective action
• Bylaw provisions should comply with the minimum standards of HCQIA, but not more
• Bylaw provisions should comply with state and federal law so as to insure confidentiality
• Document, document, document throughout the course of a corrective action
Result: Improve the quality of care, maintain confidentiality of privileged documents, protect your institution and those who participate in the process by guaranteeing HCQIA immunity from civil action damages