lb Baylor St. Luke's I ca I ce nte 6720 Bertner Ave. MC 2?1 14 Transplant Services Houston, TX 77030 January 29, 2018 Shannon Hills-Cline Acting Manager, Enforcement Branch Department of Health Human Services Centers for Medicare Medicaid Services Dallas Regional Of?ce 1301 Young St. Room 827 Dallas, TX 75202 Dear Ms. Hills-Cline, In response to the onsite transplant re-approval survey conducted on December 1, 2017 at CHI St. Luke?s Health, Baylor St. Luke?s Medical Center and the revised letter received on January 19, 2018, please ?nd the attached required Plan of Correction documentation. Please contact me if you have any questions. Macon Woodard, MHSM, BSN, RN Nurse Manager Cardiothoracic Transplant Programs Transplant Services Baylor St. Luke?s Medical Center 6720 Bertner Ave, MC 2?1 14A Houston, TX 77030 832.355.3425 (0) 832.355.9006 DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED CENTERS FOR MEDICARE 8: MEDICAID SERVICES OMB NO. 0938-0391 STATEMENT OF DEFICIENCIES not MULTIPLE CONSTRUCTION AND PLAN OF CORRECTION IDENTIFICATION NUMBER A. BUILDING COMPLETED assess a WING 1201:2017 NAME OF PROVIDER OR SUPPLIER STREET ADDRE SE Ci'f?r'. STATE. ZIP CODE A Medicare Transplant Re-approval survey was conducted on site from 11128117 through 12I01l17. The entrance conference convened on 11/28/17 at 0940 hours with Hospital Administration and the Transplant Program staff. An exit conference conducted on 120111? at 1430 hours included the hospital's Administrators and Transplant Program staff. All citations are from samples drawn from cases subsequent to the effective date of Subpart within the last three years. Each de?ciency statement includes a reference to the organ program to which the de?cient practice applies. The Medicare Transplant Re-approval included the following type of organ transplant programs: Adult Heart Only (AHO). Adult Kidney Only (AKO). Adult Live (ALI). and Adult Lung Only (ALO). The de?ciencies below are cited as a result of 42 CFR ?4az.ea through The plan of correction however must relate to the process and outcomes of all patients af?liated with the AHO. AKO. ALI. and ALO programs. Glossary: AHO Adult Heart Only AKO Adult Kidney Only ALI Adult Liver ALO Adult Lung Only CMS The Centers for Medicare Medicaid Services SRTR Scienti?c Registry of Transplant Recipient TPQR Transplant Program Quarterly Report Baylor St. Luke's Medical Center is committed to improving quality and patient safety. This Plan of Correction (P00) is submitted as part of the ongoing effort to provide the highest quality Of care to our patients and to meet federal and state requirements. Leadership. as described throughout this POC. including but not limited to the. Chief Executive Officer. Chief of Transplant Services and the Manager of Cardlothoracic Transplant Programs. have assisted in the development and implementation of this POC. Noti?cation of the Bgard and Leagg?hig The Board and Leadership are noti?ed of organ speci?c quality care measures and outcomes through a bi-directional committee structure. The hospital quality department establishes the format and methods of reporting and provides umbrella oversight for transplant OAPI. Organ speci?c OAPI Council Committee's report to The Transplant Executive Quality Steering Committee. which reports to The Hospital Management Review Committee. The Hospital Management Review Committee reports to the Quality and Patient Safety Sub-committee of the Board. which reports directly to CHI St. Luke's Board. QAPI Oversight The OAPI Council Committee is the organ speci?c OAPI Council. involving organ specific leadership and staff. All organ speci?c staff members attend OAPI Council Committee meetings including Coordinators. Dieticians. Social Workers. Pharmacists. Financial Counselors. Transplant Management. Transplant Physicians and Surgeons. Transplant Quality Staff and other key members of the transplant team. Organ speci?c policies are reviewed and approved by the QAPI Council Committees. - The Transplant Executive Quality Steering Committee is the programmatic OAPI committee involving programmatic and hospital quality leadership. - The Management Review Committee is the Organization's OAPI Committee involving hospital and quality leadership. Transplant Services reports through Transplant OAPI to the Management Review Committee. 5720 BERTNER ST LUKES EPISCOPAL HOSPITAL TRANSPLANT HOUSTON. at man not) IO SUMMARY STATMENT or DEFICIENCIES IO PLAN OF CORRECTION Ixs; (EACH DEFICIENCY MUST BE PRECEOEO aY FULL ACTION SHOULD BE COMPLETE TAG REGULATORY OR LSC IDENTIFYING TAG CROSS-REFERENCED To THE APPROPRIATE DATE 000 INITIAL COMMENTS: 000 INITIAL COMMENTS. LABORATORY DIRECT OR PROVIDERISUPP 5 SIGNATURE Any de?ciency statement ending with an asterisk other safeguards provide suf?cient protection to 1 following the date of survey whether or not a plan patients (See Instructions Except for nursing homes. the ?ndings stated above are disclosable 90 days correction is provided For nursing homes the above findings and plans of correction are disclosable 14 (550 days following the data these documents are made available to the facility. If de?ciencies are cited. an approved plan of correction ls requisite to continued program participation ?97/ denotes a de?ciency which the institution may be excused from correcting providing it is detennlned that FORM [02-991 Previous Versions Obsolete Event ID: V7JM11 Facility ID: 920030 If continuation sheet Page 1 of DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE MEDICAID SERVICES FORM APPROVED FORM APPROVED OMB NO. 0938-0391 STATEMENT OF DEFICENCIES PROVTDERISUPPLIERICLIA MULTIPLE CONSTRUCTION SURVEY AND PLAN OF CORRECTION IDENTIFICATION NUMBER A. BUILDING COMPLETED 459005 B. WING 12ID1I2017 NAME OF PROVIDER on suppose smear cm. snare zn= cone 8720 BERTNER ST LUKES EPISCOPAL HOSPITAL TRANSPLANT HOUSTON, TX 77030 ID SUMMARY STATMENT OF DEFICIENCIES ID PLAN OF CORRECTION PREFIX DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETE TAG REGULATORY OR LSC IDENTIFYING TAG CROSS-REFERENCED TO THE APPROPRIATE DATE - The individuats as described in the corrective action will be responsible for providing updates as outlined in the Monitoring Plan section of the P00. X001 Baylor St. Luke's Medical Center believes that there are 01-29-18 001 SPECIAL REQUIREMENTS FOR TRANSPLANT mitigating factors which have contributed to this non? CENTERS compliance and would like CMS to reconsider the non- AHO 432.68 compliance. Baylor St. Luke's Medical Center will be submitting a formal application for mitigating factors. Please accept the intent to apply as our plan of correction. A tranSplant center located within a hospital that has a Medicare provider agreement must meet the conditions of participation Speci?ed in ?482.72 through ?482.104 in order to be granted approval from CMS to provide transplant services. Unless speci?ed otherwise. the conditions of participation at ?432.72 through ?482.104 apply to heart. heart-lung. intestine. kidney. liver. lung. and pancreas centers. In addition to meeting the conditions of participation speci?ed in ?482.72 through ?482.104. a transplant center must also meet the conditions of participation speci?ed in ?482.1 through {548257. This CONDITION is not met as evidenced by: This facility's AHO program's staff did not meet this condition based on their failure to meet certain conditions of participation speci?ed in 42 CFR ?482.82. All other conditions have been met by the program excluding those identified in this report per samples reviewed. Findings: 1. This facility's AHO program was found de?cient at condition X041: ?482.82. DATA SUBMITIEXPERIENCEIOUTCOMES - REAPPROVAL 482.82 041 041 AHO Except as speci?ed in paragraph of this section and $5488.61 of this chapter. transplant FORM CHIS-2567 [02-991 Previous Versions Obsolete Event WJM 11 Facility lD: 920030 If continuation sheet Page 2 of 5 DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE 8: MEDICAID SERVICES FORM APPROVED FORM APPROVED OMB NO. 0938-0391 STATEMENT OF DEFICIENCIES PROVIDERJSUPPLIERICLIA AND PLAN OF CORRECTION IDENTIFICATION NUMBER. 459805 0(2) MULTIPLE CONSTRUCTION (XS) DATE SURVEY A BUILDING COMPLETED WING NAME OF PROVIDER OR SUPPLIER ST LUKES EPISCOPAL HOSPITAL TRANSPLANT STREET ADDRESS CITY. STATE. ZIP CODE 6720 BERTNER HOUSTON. TX ?030 ID PREFIX TAG SUMMARY STATMENT OF DEFICIENCIES DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) ID PREFIX TAG PROVIDER PLAN OF CORRECTION - CORRECTIVE ACTION SHOULD BE COMPLETE CROSS-REFERENCED TO THE APPROPRIATE DATE DEFICIENCY) 041 045 AHO Continued From page 2 centers must meet all data submission. clinical experience. and outcome requirements in order to be re-approved. This CONDITION is not met as evidenced by: Based on a review of the AHO program's October 2017 Transplant Program Quarterly Report (T FOR). it was determined that the program did not meet the regulatory expected outcomes for patient and graft survival rates for 1-year post transplant outlined in 42 CFR $5482.82 for a 3-year re-approval period. Findings: 1. A review on 11128117 of the October 2017 CMS Transplant Program Quarterly Report (T PQR) which contained data from the July 2017 Scienti?c Registry of Transplant Recipients (SRTR) Center Specific Report on outcomes showed for patients transplanted, between 0110014 to 06130116. the AHO program had higher than expected 1-year patient deaths and graft failures for transplant patients and was considered unacceptable as outlined in X045. Reference tag X045 for TPQR SRTR reported data results and staff interview OUTCOME REAPPROVAL CFR 482.82 CMS will not consider a center's patient and graft survival rates to be acceptable if: A center's observed patient survival rate or observed graft survival rate is lower than its expected patient survival rate and graft survival rate; and (ii) All three of the following thresgolds are crossed over: 041 045 FORM CMS-2567 {02-99} Previous Versions Obsolete Event ID WJM11 Facility ID: 920030 If continuation sheet Page 3 of5 DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE 8. MEDICAID SERVICES FORM APPROVED FORM APPROVED OMB NO. 0938-0391 STATEMENT OF DEFICIENCIES (X1) MULTIPLE CONSTRUCTION (X3) DATE SURVEY AND PLAN OF CORRECTION IDENTIFICATION NUMBER. A. BUILDING COMPLETED 459505 B. WING NAME OF PROVIDER OR SUPPLIER ST LUKES EPISCOPAL HOSPITAL TRANSPLANT STREET ADDRESS. CITY. STATE. ZIP CODE 8720 BERTNER HOUSTON, TX 77030 ID PREFIX TAG SUMMARY STATMENT OF DEFICIENCIES DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING ID PREFIX TAG PLAN OF CORRECTION CORRECTIVE ACTION SHOULD BE COMPLETE CROSS-REFERENCED TO THE APPROPRIATE DATE DEFICIENCY) 045 Continued From page 3 The one-sided p-value is less than 0.05, (B) The number of observed events (patient deaths or graft failures) minus the number of expected events is greater than 3, and (C) The number of observed events divided by the number of expected events is greater than 1.5. This ELEMENT is not met as evidenced by: Based on a review of the most recent Transplant Program Quarterly Report (T PQR) containing the July 2017 Scienti?c Registry of TranSpIant Recipients (SRTR) outcomes data. it was determined the AHO program's staff did not meet the regulatory outcome reqirements outlined in 42 CFR S482.82 (3) for the 1-year patient and graft survival rates. Findings: 1. A review on 11128l17 of the data from the October TPOR containing the July 2017 SRTR outcomes indicated for patients transplanted between 01l01114 to 06/30/16 that the AHO program's 1-year patient deaths and graft failures rates were signi?cantly higher than expected and considered unacceptable. 2. Data results for 1-year graft survival was reported as follows for the most recent SRTR Center? Speci?c Report for July 2017: a) Expected Graft Failure: 5.6 b) Actual Graft Failure: 12 c) p-value (signi?cance): 0.013 3. Data results for 1-year patient survival was 045 FORM [02-99] Previous Versions Obsolete Event ID V71M11 Facility ID: 920030 If continuation sheet Page 4 of 5 DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICAID SERVICES FORM APPROVED FORM APPROVED OMB NO. 0938-0391 STATEMENT OF OEFICIENCIES PROVIDERISUPPLIERIICLIA (X2) MULTIPLE CONSTRUCTION SURVEY AND PLAN OF CORRECTION IDENTIFICATION NUMBER A. BUILD COMPLETED 459805 B. WING 130112017 NAME OF PROVIDER OR SUPPLIER STREET ADDRESS. CITY STATE ZIP CODE reported as follows for the most recent SRTR Center-Speci?c Report for July 2017: a) Expected patient death: 5.33 b) Actual patient death: 11 c) p-value (signi?cance): 0.021 4. in a staff interview on 12IO1I17 at 1130 hours with AHO Transplant Physician #1 . it was veri?ed that the AHO program's management staff were aware that the 1-year graft failure and patient death rates were higher than expected. explained that the program's staff conducted an internal review and hired a Transplant Management Group to review the graft failures and patient deaths. explained that issues were identi?ed with the major issue being surgical technique with one of the heart transplant surgeons. who was no longer practicing. am BERTNER sT LUKES EPISCOPAL TRANSPLANT HOUSTON, Tx man In} ID SUMMARY STATMENT 0F DEFICIENCIES ID PROVIDER PLAN OF CORRECTION {st PREFIX DEFICIENCY MUST BE PRECEDED FULL PREFIX CORRECTIVE ACTION SHOULD BE COMPLETE TAO REGULATORY OR IDENTIFYING INFORMATION) TAO To THE APPROPRIATE DATE DEFICIENCY) 045 Continued From page 4 045 FORM CHIS-2567 [02-99) Previous Versions Obsolete Event ID: Facility ID: 920030 If continuation sheet Page 5 of 5