CMS SOM App. Y, Tag Z057

An OPO must have a written agreement with 95 percent of the Medicare and Medicaid

participating hospitals and critical access hospitals in its service area that have both a

ventilator and an operating room and have not been granted a waiver by CMS to work

with another OPO. The agreement must describe the responsibilities of both the OPO

and hospital or critical access hospital in regard to donation after cardiac death (if the

OPO has a protocol for donation after cardiac death) and the requirements for hospitals at

§ 482.45 or §485.643. The agreement must specify the meaning of the terms ‘‘timely

referral’’ and ‘‘imminent death.’’

Interpretive Guidelines §486.322(a)

Request the written agreements for a percentage of the hospitals in the donation service

area. Either create a list of all hospitals and CAHs in the service area prior to going on

site or ask the OPO for a list of all hospitals and CAHs in their service area. Eliminate

those hospitals/CAHs in the service area that currently have waivers to work with another

OPO and ensure that the list of hospitals/CAHs for this OPO includes those facilities

outside the service area that have waivers to work with this OPO. The surveyor should

select the following sample size.

Less than 100 hospitals in the service area …………..Select 10% at random;

More than 100 hospitals in the service area…………..Select 05% at random.

If during the review of the sample, the surveyor determines that the OPO does not have a

current agreement with one or more hospitals/CAHs in their service area, request

additional information to determine whether the hospital/CAH has a ventilator and

operating room or whether the hospital/CAH has an approved waiver to work with

another OPO. Disregard any hospital/CAH that does not meet the criteria or has an

approved waiver in place. If the hospital(s) does meet these criteria or does not have an

approved waiver in place, expand the sample to a 100% review to verify that the OPO

has an agreement with at least 95% of the Medicare and Medicaid participating

hospitals/CAHs in the donation service area that have both a ventilator and an operating

room.

If the OPO for a donation service area has changed since the last survey, due to a CMS

change of designation or CMS approval of a merger of two OPOs, verify that the OPO

has effected new agreements with the Medicare certified hospitals and CAHs in the

service area. In those instances where there is no agreement and there is no pending

request for waiver (submitted within 30 days of the notice of change of designation), look

for written documentation to show effort by the OPO to obtain a new agreement. If such

documentation is available but the hospital or CAH refuses to enter into an agreement

with the newly designated OPO and there is no waiver request pending, do not cite the

OPO for a deficiency under this regulation but make a referral to the applicable State

Survey Agency for possible hospital/CAH complaint investigation per §482.45/§485.643.

If the OPO has a written agreement with any hospital/CAH outside of its service area

and cannot provide evidence of a waiver for that facility, either currently pending with

CMS or approved by CMS, (see approval requirements at §486.308(e)), cite a deficiency

under §486.322(a). Inform the OPO that the agreement must be terminated and the

facility must be given any necessary assistance to secure an agreement with its designated

OPO. Refer the finding to the applicable State Survey Agency for possible investigation

under §482.45 or §485.643 as appropriate.

Prior to going on-site, check the CMS OPO Database report to identify:

1. any waiver denials issued, or

2. any pending hospital/CAH request to return to its designated OPO after a previous

waiver approval.

During the on-site review, verify that there is a written agreement in place between the

OPO and any hospital or CAH within the OPO’s donation service area which requested a

waiver and the waiver was subsequently denied by CMS.

Review the agreements to ensure that they include the responsibilities of both the OPO

and the hospital/CAH and describe how they will work together collaboratively.

Deficiencies found at §486.303(g) should be cited at this regulation §486.322(a).

The hospital/CAH agreement should address:

a) Appropriate hospital staff participation in training provided by or approved by the

OPO;

b) Staff roles/expectations for approaching the families regarding possible donation;

c) Parameters for timely notification of the OPO of an imminent death (Agreement

should define “timely referral” and the clinical triggers which would indicate an

“imminent” death.)

d) Access by the OPO to hospital services such as laboratory services, radiological

services, operating room availability or anesthesia services on a 24/7 basis;

e) OPO access to hospital medical records and the arrangements for copies to be

made of the hospital medical records requested by the OPO;

f) Hospital/CAH staff role/responsibilities for management of organ viability;

g) Hospital/CAH staff role/responsibilities for procedures during Donation after

Cardiac Death (DCD), if applicable. (The hospital may elect to opt out of DCD.);

h) Hospital/CAH requirements for the qualifications that must be provided by the

OPO for organ recovery team members upon request by the hospital;

i) Notification of the OPO of any change in hospital privileges, which affect the

privilege of organ recovery, for any surgeon or other recovery personnel from the

hospital routinely recovering organs for the OPO; and

k) Roles and responsibilities of surgeons and other personnel recovering for an

OPO.

The OPO responsibilities should address:

a) The provision of:

1. timely communication and prompt response by the OPO on a 24/7 basis;

2. orientation training for new Designated Requestors and annual training for

all Designated Requestors;

3. annual hospital specific organ donation data.

b) The determination of the suitability of the donor;

c) The parameters for OPO interaction with hospital/CAH staff and families or the

legally authorized representative;

d) Use of sensitivity in discussions with families or with the legally authorized

representative;

f) The notification to the hospital/CAH of any OPO policy changes that affect the

role of the hospital/CAH in recovery, perfusion or transport;

g) The assurance that:

1. organ recovery teams are of the proper composition and qualifications;

2. proper documentation is prepared for the transplant program about the

recovered organ(s) including blood type and other identifying information;

h) The role of the OPO staff:

1. in organ/tissue management within the hospital/CAH; and

2. with the interactions with the family or the legally authorized representative

in cases of first person consent.

i) OPO roles, responsibilities and collaboration with the hospital staff on DCD, if

applicable.