Governing Body

§482.12 

CMS has revised the CoP regarding governing body to permit one governing body to oversee multi-hospital “system” governance structures—for example, where a parent health care system board also acts as the governing body for its member hospitals.  This type of structure is favored for reasons of efficiency, effectiveness and integration.  Importantly, and diverging from the proposed version of the changes to this CoP, CMS has also included a new requirement that one or more members of the hospital’s medical staff be made part of the governing body of the hospital.  The stated reason for this change is to increase the communication between the governing body and medical staff and to provide a formalized link between the governing body and the medical staff; however, it is a requirement that some hospitals—such as governmental hospitals where the governing body is appointed by governmental action or through election—may be unable to meet. 

Hospitals must ensure that their governing body structure meets CMS requirements and is compliant with state and federal law.  The revised CoP does not preempt state or federal laws that may require separate governing bodies.  Hospitals must also ensure that they have a member of the medical staff on the governing body moving forward.  Where a governing body has oversight of more than one hospital, it is not required that a member of each medical staff be on the governing body, but rather that one medical staff member from one of the medical staffs provides representation.  Governing documents outlining the composition of the governing body, such as corporate bylaws, may need to be amended in order to facilitate this change.  CMS is aware of the issue raised by those hospitals that have limited control over the composition of their governing bodies, and may address this concern in future guidance. 

Patient Rights – Restraint-Related Death Reporting

§482.13

Hospitals have long been required to report to CMS deaths that occur while patients are in restraint or seclusion, or recently following a period of restraint or seclusion.  Under the revised CoPs, hospitals need not report to CMS the death of patients in (or who have recently been in) two-point soft wrist restraints without seclusion.  This will help differentiate between patients who expire in restraints used in the post-operative period, such as those who are critically ill and have restraints only to prevent removal of ventilator tubes, IV lines and the like, from those whose death is more closely related to the use of restraint or seclusion.  Hospitals must create an internal log of these patient deaths and provide the log to CMS upon request.  CMS also proposes enhancements to restraint death reporting to include electronic and facsimile reporting, and a requirement that report of restraint death to CMS or logging on the internal hospital log be noted in the patient’s medical record. 

Hospitals should review and revise their restraint death reporting policies and procedures to reflect those types of restraint-related deaths that require reporting versus those that may be recorded on an internal log, as well as the permissible manner of reporting and the need to document in the patient’s medical record reporting to CMS or inclusion in a log.  Hospitals must ensure that staff are educated on the revised policies.  A tracking log of deaths of patients in soft wrist restraints must be developed to include the information points required by CMS:  the patient’s name, date of birth, date of death, attending physician, medical record number, and primary diagnosis or diagnoses.  Deaths meeting the criteria for inclusion in an internal log must be logged within seven days of the death.  

Medical Staff – Definition of Medical Staff

§482.22

The CoPs have been revised to include a broader definition of medical staff that includes non-physician practitioners who are granted privileges.  This will give hospitals the flexibility to allow other practitioners, such as advanced practice nurses, physician assistants and pharmacists, to be part of the medical staff and to perform functions within their scope of practice within that structure. 

Hospitals may consider using the broader definition of medical staff, but are not required to do so.  If the governing body proposes a broader definition of medical staff, changes in the medical staff bylaws will be necessary to ensure consistency.  Changes to the medical staff bylaws may not be made unilaterally, meaning that changes cannot be made by the hospital without the input and approval of the medical staff.  As such, any changes to the medical staff bylaws will require close coordination with the medical staff. 

Medical Staff – Medical Staff Leadership

§482.22

CMS has revised the CoPs to provide that a podiatrist may be responsible for organization and conduct of the medical staff—essentially permitting podiatrists to serve in medical staff leadership positions where not otherwise prohibited by state law. 

Hospitals may choose to expand the role of podiatrists within their existing medical staff structure, but are not required to do so. 

Nursing Services – Nursing Care Plans

§482.23

The CoPs revisions permit nursing care plans to be maintained as stand-alone plans or as part of a single interdisciplinary care plan that addresses nursing and other disciplines.  This is a change from the prior requirements for a separate nursing care plan. 

Hospitals may choose to have a combined interdisciplinary care plan or a separate nursing care plan.  Policies and procedures that refer to the nursing care plans must be revised to reflect any changes in process, and education of nursing staff must be undertaken to ensure a consistent understanding within the nursing staff structure. 

Nursing Services – Medication Administration

§482.23

The revised CoPs permit hospitals to develop patient self-administration programs for certain medications. 

Hospitals that intend to develop a program for self-administration must first put in place a program that addresses safety and accuracy concerns, including the development and implementation of policies and procedures to address security of the medications as well as the method of documentation administration in the patient’s medical record.  Hospitals have the flexibility to design a program with the level of control they desire.  

Nursing Services – Administration of Blood Transfusions and Intravenous Medications

§482.23

The revised CoPs have changed the requirement for non-physician personnel to have special training to administer blood transfusions or intravenous medications, and refer instead to such administration being done in accordance with state law and medical staff policies and procedures. 

Hospitals should consider whether or not their methods of administration and education comply with the revised condition of participation.  Hospital requirements may be more stringent than the CoPs, to the extent this is determined appropriate by the hospital.  (Note that the revised CoP references administration of blood transfusions and intravenous medications pursuant to “medical staff” policies and procedures, where many hospitals likely have nursing or other clinical policies that are the basis for administration within the hospital.) 

Nursing Services – Orders by Other Practitioners

§482.23 

CMS will permit orders for drugs and biologicals to be prepared and administered on the order of practitioners other than a physician in accordance with hospital policy and state law.  This change allows non-physicians to write orders to the extent it is within their scope of practice to do so and state law and hospital policy permit it. 

Hospitals should determine whether or not their current medication ordering and administration policies reflect the CMS requirements, and update the policies to reflect this requirement as desired. 

Medical Record Services – Standing Orders

§482.24

The revised CoPs permit hospitals to utilize standing orders, order sets and protocols, which tools must be reviewed and approved by the medical staff, nursing and pharmacy before implementation.  All standing orders, order sets and protocols are to be based on nationally recognized and evidence-based guidelines and recommendations. 

To the extent such tools are used, hospitals should align policies, procedures and practices to reflect the CoP requirements for standing orders, order sets and protocols. 

Medical Record Services – Verbal Orders

§482.24

CMS has made final the temporary provision that permits authentication of verbal orders by the practitioner placing the order or another practitioner who is caring for the patient, as long as they meet hospital and state law requirements for writing orders.  All orders must be dated, timed and signed.  CMS has also removed the requirement that orders be authenticated within 48 hours and instead will defer to applicable state law to establish authentication time frames. 

Hospitals may wish to revisit their verbal order policies and procedures to determine whether or not changes are warranted.  As with standing orders, it is possible for a hospital to choose to be more restrictive than the CMS CoP in setting verbal order requirements.  The timing for authorization of orders requirement in some states is 48 hours, which in those cases negates the benefit of the timeline’s removal from the CoPs. 

Infection Control

§482.42

The revised CoPs eliminate the requirement for a hospital to maintain a separate infection control log.  CMS has acknowledged that hospitals already monitor infections and have various surveillance methods in place, and has determined that a separate infection control log is therefore obsolete. 

Infection control preventionists should evaluate their existing monitoring and tracking mechanisms to be confident that they are sufficiently tracking infection control and prevention matters.  Any separate log maintained to ensure compliance with the CoP can be discontinued as of the effective date of the revised CoPs. 

Outpatient Services

§482.54

CMS has acknowledged that it is outdated and burdensome for a hospital to have a single individual acting as the director of outpatient services to oversee outpatient service departments in a hospital, and has removed the requirement from the CoPs.  

Hospitals may choose to revisit the manner in which they designate the director of outpatient services, and may now implement a departmental or other organizational structure that clarifies the roles and responsibilities of department directors.

Transplant Center Process Requirements

§482.92

The revised CoPs eliminate a duplicative requirement that organ recovery teams conduct a blood type and other final data verification process before organ recovery.  This change is geared toward reducing duplication of efforts related to organ procurement, as this information is verified twice elsewhere in the process. 

Hospitals should revisit their organ procurement policies to ensure there is no duplication or requirements for the additional check to occur.  Because hospitals will be expected to comply with their policies and procedures, to the extent such a check is included in the policy, they will be expected to comply with the policy. 

Critical Access Hospitals –Provision of Services

§485.635

The revised CoPs bring a welcome change for critical access hospitals (CAHs).  CAHs may now provide diagnostic and therapeutic services, laboratory services, radiology services and emergency procedures under arrangements, and need not be limited to services provided directly by hospital staff. 

CAHs are now free to evaluate the best way of providing the identified services and utilize outside providers as the CAH determines appropriate.