Goal 7. Understand the concept of the genetic code and genes.
Describe meiosis, contrasting it with mitosis. Explain the
relationship between meiosis and genetics. Solve problems
involving human transmission genetics.
A. Meiosis Goal 7.01
attending these informational sessions with the donor and creating opportunities for the living donor to discuss issues, ask additional questions,
or request follow-up information. If the information is provided directly by the Living Donor Advocate, the
(b) A center that performs 50 percent or more of its
transplants in a 12-month period on adult patients must be
approved to perform adult transplants in order to be
approved to perform pediatric transplants.
This section applies only if both the adult and
We consider it implicit in any concept of adequate training that there
would be: (a) a thorough orientation to the programs policies and
procedures; (b) structured continuing education for nursing staff and
clinical transplant coordinators; and (c) an eva
Request the programs log of reported adverse events over the past 12
months (but not prior to June 28, 2007). Verify that the program
followed its policies on investigation, reporting, and analysis.
During the review of post-June 28, 2007 medical records
For transplant patients:
Review the transplant programs written clinical management policies for
the transplant and discharge phases of transplantation (including the posttransplant period following discharge from the hospital) including routine
Based on the requirement that the participating hospitals QAPI program
cover all areas of the hospital, the transplant programs QAPI program
must be incorporated into the hospitals overall QAPI program. The
transplant programs portion of the QAPI program
This standard applies when the transplant program sends its own team to
recover the an organ(s) that will be transplanted at that same transplant
center. Review the transplant program written policies and procedures to
verify that the programs organ recov
(c) Standard: Outcome Requirements.
(2) The required number of transplants must have been
performed during the time frame reported in the most
recent SRTR center-specific report.
(3) CMS will not consider a centers patient and graft
survival rates to be a
Initial approval for purpose of this section means the program is first
approved under these Conditions of Participation.
Review the most recent TPQR for the number of transplants performed
over the previous 12-month period.
The following types of program
482.92 Condition of Participation: Organ Recovery
Transplant centers must have written protocols for
validation of donor-recipient blood type and other vital
data for the deceased organ recovery, organ receipt, and
living donor organ transpla
(a) Standard: Patient and Living Donor Care.
The transplant centers patient and donor management
policies must ensure that:
(1) Each transplant patient is under the care of a
multidisciplinary patient care team coordinated by a
physician throughout the tr
Adverse Event Definition 482.70Adverse event means an untoward, undesirable, and usually
unanticipated event that causes death or serious injury, or the risk thereof.
As applied to transplant programs, examples of adverse events include
(but are not limit
Review the written patient selection policy to verify that it contains a
requirement for a prospective transplant candidate to receive a
psychosocial evaluation by a qualified healthcare professional PRIOR
TO PLACEMENT ON THE WAITING LIST. The policy is e
(b) Standard: Clinical Experience.
To be considered for re-approval, an organ-specific
transplant center must generally perform an average of 10
transplants per year during the re-approval period.
Review the most recent TPQR for the average number of
The QAPI program must includeInclude the participation of the transplant programs key personnel (Director, primary transplant surgeon,
primary transplant physician, clinical transplant coordinator, and nursing personnel). Examples of their participation
The kidney or kidney/pancreas transplant program must have ongoing
communication with all dialysis facilities associated with patients on the
transplant programs waiting list.
The transplant program must have written policies that describe the
(c) Standard: Patient Records.
Transplant centers must maintain up-to-date and accurate
patient management records for each patient who receives
an evaluation for placement on a centers waiting list and
who is admitted for organ transplantation.
(1) For e
A transplant program served by a single transplant surgeon and/or
transplant physician must have written policies and procedures in place
to inform the patients on the programs waiting list regarding: (a) the
potential unavailability of the transplant sur
(e) Standard: Transplant Team.
The transplant center must identify a multidisciplinary
transplant team and describe the responsibilities of each
member of the team. The team must be composed of
individuals with the appropriate qualifications, trainin
(1) Ensure that a prospective living donor receives a
medical and psychosocial evaluation prior to donation,
For a center that performs living donor transplants, verify that the
transplant programs policy requires that prior to donation, the
(4) The availability of alternative treatments for the
Prior to consent for donation, the donor must be informed of the alternate
treatment regimen(s) available to the transplant candidate in lieu of
receiving a donated organ. This d
Discussions regarding potential medical or psychosocial risks should
occur early in the evaluation process and with any major material change
in the patients medical or psychosocial condition.
Discussion of potential medical risks should include, at a min
Subpart E Requirements for Specialty Hospitals
(c) Standard: Participation in network activities.
Kidney transplant centers must cooperate with the ESRD
Network designated for their geographic area, in fulfilling
the terms of t
(1) The transplant surgeon is responsible for providing
surgical services related to transplantation.
Review a sample of post June 28, 2007 transplant recipients medical
records for evidence that the transplant surgeon performs or supervises
A qualified social worker is an individual who meets
licensing requirements in the State in which he or she
(1) Completed a course of study with specialization in
clinical practice and holds a masters degree from a
graduate school of social
Review the transplant programs written transplant patient selection
criteria. The selection criteria (medical, psychosocial, financial, etc.)
must clearly define the characteristics of the patients for whom the
program will and will not provide transplant
Attachment A: Organ Transplant Surveys, Interpretive Guidelines Interim 2.0
482.68 Special Requirements for Transplant
A transplant center located within a hospital that has a
Medicare provider agreemen
Surveyors will likely need to visit both sites to verify that the program
that is jointly-operated by the hospital and another Medicare-approved
heart transplant program and that the two programs are operating in a
Review the policies and
Note: This section does not apply to surveys for initial approval
During the course of the survey process (interviews, review of medical
records, waiting list, transplant list, etc.) note any extended period of
time when there were significa
The evaluation process begins at the time an individual is identified as a
potential transplant candidate and continues until the time the individual
is placed on the waiting list.
During the evaluation time period, the following topics, at a minimum,
approval under 482.80.
During the course of the survey process (interviews, review of medical records, waiting list, transplant list, etc.) note any extended period of time
when there were significant changes occurring at the transplant program which woul
Review the transplant programs policies and procedures to verify a
requirement that when an organ arrives at the transplant program, a
transplant surgeon and another licensed healthcare professional must
verify that the donors blood type and donor identif
Verify that the transplant programs policies and procedures for
nutritional services after June 28, 2007 outline how the transplant
program will determine when a complete nutritional assessment, dietetic
counseling, or nutritional intervention is warrante
(4) Inactivation of the transplant center.
Transplant programs will be required to notify CMS when the program is
1) unable to serve patients, as a group, for a sustained and significant
time period, where a period of 15 days or more is presu