CMS SOM App. W, Tag C-1511

tissue bank and eye bank in educating staff on donation issues, reviewing death

records to improve identification of potential donors, and maintaining potential

donors while necessary testing and placement of potential donated organs, tissues,

and eyes takes place.

§485.643(f) For purpose of these standards, the term “organ” means a human

kidney, liver, heart, lung, pancreas, or intestines (or multivisceral organs).

Interpretive Guidelines §485.643(e)

Appropriate staff, including all patient care staff, must be trained regarding donation

issues and how to work with the OPO, tissue bank and eye bank. Those CAH staff who

may have to contact or work with the OPO, tissue bank and eye bank staff, must have

appropriate training on donation issues including their duties and roles.

The training program must be developed in cooperation with the OPO, tissue bank and

eye bank, and should include, at a minimum:

• Consent process;

• Importance of using discretion and sensitivity when approaching families;

• Role of the designated requestor;

• Transplantation and donation, including pediatrics, if appropriate;

• Quality improvement activities; and

• Role of the organ procurement organization.

Training should be conducted with new employees annually, whenever there are

policy/procedure changes, or when problems are determined through the CAH’S QA

program.

CAHs must cooperate with OPOs, tissue banks and eye banks in regularly/periodically

reviewing death records. This means that a CAH must develop policies and procedures

which permit the OPO, tissue bank and eye bank access to death record information that

will allow the OPO, tissue bank and eye bank to assess the CAH’S donor potential,

ensure that all deaths or imminent deaths are being referred to the OPO in a timely

manner, and identify areas where the CAH, OPO, tissue bank and eye bank staff

performance might be improved. The policies must address how patient confidentiality

will be maintained during the review process.

The CAH must have policies and procedures, developed in cooperation with the OPO,

that ensure that potential donors are maintained in a manner that maintain the viability of

their organs. The CAH must have policies in place to ensure that potential donors are

identified and declared dead within an acceptable time frame by an appropriate

practitioner.

Survey Procedures §485.643(e)

• Review inservice training schedules and attendance sheets.

• How does the CAH ensure that all appropriate staff have attended an educational

program regarding donation issues and how to work with the OPO, tissue bank,

and eye bank?

• Verify by review of policies and records that the CAH works with the OPO, tissue

bank, and eye bank in reviewing death records.

• Verify that the effectiveness of any protocols and policies is monitored as part of

the CAH’S quality improvement program.

• Validate how often the reviews are to occur. Review the protocols that are in

place to guide record reviews and analysis.

• Determine how confidentiality is ensured.

• Verify that there are policies and procedures in place to ensure coordination

between the facility staff and the OPO staff in maintaining the potential donor.

• Determine by review, what policies and procedures are in place to ensure that

potential donors are identified and declared dead by an appropriate practitioner

within an acceptable timeframe.