DEPARTMEN T OF H EALTH & H UMAN SERVICES
Centers for Med icare & Med icaid Services
Dallas Regional Office
1301 Young Street, Room 827
Dallas, Texas 75202

D IVISION OF S URVEY & CERTIFICATION , REGION VI

This notice revises the CMS letters dated December 12, 2017, and December 27, 2017, to modify
the survey findings and issue an amended CMS-2567.
January 19, 2018

CMS Certification Number (CCN): 459805
Hospital CMS Certification Number (CCN): 450193
OPTN: TXHI
Macon S. Woodard, MHSM, BSN, RN
Chi St Luke's Health Baylor College of Medicine Center
6720 Bertner
Houston, TX 77030
Dear Ms. Woodard:
On December 1, 2017, the Centers for Medicare & Medicaid Services (CMS) conducted an onsite
re-approval survey at Chi St. Luke’s Baylor College of Medicine Center Transplant Hospital.
Regulations at 42 CFR §488.3 require that a provider must be in compliance with applicable Medicare
Conditions of Participation. The following organ transplant programs were surveyed at Chi St. Luke's
Health Baylor College of Medicine Center Transplant Hospital:
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Adult Heart Only – AHO
Adult Kidney Only – AKO
Adult Liver - ALI
Adult Lung Only - ALO

Survey Findings
Chi St. Luke's Health Baylor College of Medicine Transplant Hospital is in substantial compliance with
the conditions of Participation found at 42 CFR §488.3 for the AKO, ALI, and ALO programs.
Therefore, your eligibility for Medicare participation remains in effect for AKO, ALI, and ALO.
Based on further administrative review, the CMS has determined the results of the survey findings
demonstrate that your transplant center for Adult Heart Only – AHO is out of compliance with the
following Conditions of Participation:
42 CFR §482.68 - Special Requirements for Transplant Centers – Reapproval, Tag X001
Deficiencies apply to the Adult Heart Only - AHO

 42 CFR §482.82 – Data Submit/Experience/Outcomes – Reapproval, Tag X0041
Deficiencies apply to the AHO
As a result of the findings, your AHO transplant program has been given a prospective Medicare
termination date of August 17, 2018 (210 days from the date of this letter).
The deficiencies cited in the enclosed CMS-2567 at 482.82 is based upon data provided by the
Scientific Registry of Transplant Recipients (SRTR). Because it is data from a specific time period as
defined by the Conditions of Participation, there is no action you may take to change or correct the
deficiency as written. However, if you believe that there are mitigating factors which have contributed
to this non-compliance and you wish CMS to reconsider the non-compliance based upon those
mitigating factors, please include your intent to apply for the reconsideration as your plan of correction
for the deficiency within 10 calendar days of the receipt of this letter.
You must then submit your formal application for consideration of mitigating factors to CMS at
SCG_Transplantteam@cms.hhs.gov. within 120 days of the date of this letter. The application must
include:
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A brief summary of the mitigating factors requested;
Rationale and supporting evidence for the mitigating factors request;
Internal program improvement that have been made to address the mitigating factors;
Program outcome data representing the time period following the most recent SRTR report to
current date;
Program QAPI material (QAPI plan, current dashboard, meeting minutes for the most recent 12
months);
Root Cause Analysis reports;
Any pertinent program protocols, policies, and procedures.

For additional information regarding an application for consideration of mitigating factors please visit
the CMS website at: https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/
CertificationandCompliance/Downloads/ConsiderationofMitigatingFactors.pdf.
Please be advised that if you do not choose to apply for consideration of mitigating factors for the
non-compliance cited in the enclosed report, the Medicare approval for the AHO will be terminated
within 30 calendar days from the date of receipt of this letter. If you do submit a plan of correction
that you intend to apply for reconsideration based on mitigating factors but do not submit the
application to CMS within 120 days of the date of this letter or CMS finds, after consideration of the
materials submitted as a part of the application, that the information you provided does not mitigate the
non-compliance, the termination of the AHO will proceed and you will be notified of the termination
date.
You should be aware that copies of the form CMS-2567 and POCs are releasable to the public upon
request in accordance with the provisions at 42 CFR §401.133.
Mitigating factors will not be considered or approved if the program has an outstanding finding of
Immediate Jeopardy (i.e., cases where non-compliance with any other Conditions of Participation has
caused or is likely to cause serious injury, harm or impairment or death, and where immediate
corrective action is needed).

 The regulation at 42 CFR §488.61 describes the general areas that will be reviewed in determining
whether a program can be approved based on mitigating factors. Please note that our intent is to
construe this provision quite narrowly given the factors for consideration outlined in the regulation and
our responsibilities to ensure compliance with the Medicare Conditions of Participation for transplant
programs. Transplant programs should refer to the CMS website for additional information about the
process.
The requirement that Chi St. Luke's Health Baylor College of Medicine must submit a plan to correct
its Medicare transplant program deficiencies before it is granted approval of the above listed transplant
program does not affect the current status of Chi St. Luke's Health Baylor College of Medicine as a
participating provider of hospital services in the Medicare Program.
If you have any questions please contact Jacque Smith at jacque.smith@cms.hhs.gov or at
214-767-4436.
Sincerely,

Shannon Hills-Cline,
Acting Manager Enforcement Branch
Enclosure: Form CMS-2567 (survey report)
cc: CMS Central Office; HCMS