DEPARTMENT OF HEALTH & HUMAN SERVICES Centers for Medicare & Medicaid Services CMS Philadelphia 801 Market Street, Suite 9400 Philadelphia, PA 19107-3134 Northeast Survey & Enforcement Division January 14, 2020 Sent via Email (confirmation of successful transmission constitutes proof of receipt) Newark Beth Israel Medical Center Newark Beth Israel Medical Center- Transplant Hospital 201 Lyons Avenue Newark, New Jersey 07112 Att: Darrell K. Terry, SR, President & Chief Executive Officer Darrell.Terry@rwjbh.org Denise Shepherd, Vice President, Quality and Safety Denise.Shepherd@rwjbh.org Dr. Matthew J. Shreiber, Chief Operating Officer Matthew.Schreiber@rwjbh.org Re: CMS Certification Number: 310002 CMS Certification Number: 319803 Dear Mr. Terry: IMPORTANT NOTICE - PLEASE READ CAREFULLY Section 1865 of the Social Security Act and implementing regulations permit a hospital accredited by The Joint Commission (TJC) or other applicable Accrediting Organizations to be deemed to meet all of the Medicare Conditions of Participation. 42 U.S.C. § 1395bb; 42 C.F.R. §488.4. Section 1864 of the above Act and the implementing regulation authorize the Secretary of Health & Human Services to conduct, on a selective sampling basis or in response to substantial allegations of non-compliance, surveys of accredited hospitals participating in Medicare as a means of validating the accreditation survey process. 42 U.S.C. § 1395aa; 42 C.F.R. §488.9. If, in the course of such a survey, a hospital is found not to meet one or more of the Medicare Conditions of Participation, the hospital will no longer be deemed to meet any Medicare Conditions of Participation. 42 U.S.C. § 1395bb (c); 42 C.F.R. §488.9. Also, we are required to place the hospital under Medicare State Agency survey jurisdiction until it is in compliance with all Medicare Conditions of Participation. The New Jersey Department of Health (The State Agency) completed a Revisit survey of the hospital, and the hospital’s Transplant Program, on December 18, 2019, in response to an Immediate Jeopardy that was identified on December 12, 2019. The State Agency determined that the facility implemented corrective measures to resolve the Immediate Jeopardy. As a result, CMS will not initiate administrative steps to terminate the facility’s Medicare agreement, retroactively January 4, 2020. Page 2 – Newark Beth Israel Medical Center However, the facility remains out of compliance with the participatory requirements and is required to submit an acceptable Plan of Correction. These findings, along with the resolution of the Immediate Jeopardy, are explained in the enclosed Form CMS-2567s (Statement of Deficiencies). CMS concurs with these findings and, as a result, has determined that the hospital remains out of compliance with the following Medicare Conditions of Participation for Hospitals: 42 C.F.R. § 482.13- Patient Rights 42 C.F.R. § 482.21- QAPI 42 C.F.R. § 482.51- Surgical Services In addition, the hospital’s Transplant Program remains out of compliance with the following Medicare Conditions of Participation for Hospitals- Subpart E- Requirements for Specialty Hospitals- Special Requirements for Transplant Programs: 42 C.F.R. § 482.68- Special Requirements for Transplant Centers 42 C.F.R. § 482.96- Quality Assessment/Performance Improvement 42 C.F.R. § 482.102- Patient and Living Donor Rights You are advised that failure to achieve compliance with the Conditions of Participation, in accordance with the time frames set forth in an acceptable plan of correction, will result in the initiation of action to terminate your facility from the Medicare program. We will initiate administrative steps to terminate your Medicare agreement by March 21, 2020, if compliance is not achieved and verified prior to that date. The State Agency may perform monitoring visits to determine your progress toward correcting the deficiencies. At this time, these findings do not affect your hospital's accreditation, its Medicare payments, or its status as a participating provider of hospital and Transplant services in the Medicare program. However, you are required to submit an acceptable plan of correction regarding these deficiencies. After the approved plan of correction is implemented and we have found that all of the Medicare Conditions of Participation for Hospitals, and the Transplant Program, are met, we will discontinue The State Agency’s survey jurisdiction. A copy of this letter is being forwarded to The Joint Commission (TJC) and The New Jersey Department of Health. A complete listing of all deficiencies is attached (CMS-2567). Newark Beth Israel Medical Center and Newark Beth Israel Medical Center- Transplant Hospital is required to submit an acceptable plan of correction, with time schedules, for all deficiencies cited as the result of the survey. You must submit your plan of correction within 10 calendar days of receipt of this letter to Tara Hurley, Supervising Healthcare Evaluator, New Jersey Department of Health via email at Tara.Hurley@doh.nj.gov or via fax at (609) 943-4977 with a copy to the attention of CAPT Maury Meredith, Centers for Medicare & Medicaid Services, via email at Maury.Meredith@cms.hhs.gov or via fax at (443) 380-6903. Please indicate your corrective actions on the right side of the Form CMS-2567 in the column labeled "Provider Plan of Correction" (PoC), keying your responses to the deficiencies on the left. You may document your corrective actions as a WORD document, but please ensure that you clearly reference the regulation to the respective PoC. Additionally, indicate your anticipated completion dates in the column labeled "Completion Date", or on the WORD document. As a reminder an authorized representative must sign, date and return the 2567(s) to our office, in addition to submitting the PoC. An acceptable PoC must contain the following elements: Page 3 – Newark Beth Israel Medical Center 1. The plan for correcting each specific deficiency cited; 2. The plan for improving the processes that led to the deficiency cited, including how the hospital is addressing improvements in its systems in order to prevent the likelihood of recurrence of the deficient practice; 3. The procedure for implementing the PoC, if found acceptable, for each deficiency cited; 4. A completion date for correction of each deficiency cited (the corrective action completion dates must be acceptable, generally no longer than 60 days from the date of this notice); 5. The monitoring and tracking procedures that will be implemented to ensure that the PoC is effective and that the specific deficiencies cited remain corrected and in compliance with the regulatory requirements; and 6. The title of the person(s) responsible for implementing the acceptable PoC. Copies of the Form CMS-2567, including copies containing the facility’s PoC, are releasable to the public in accordance with the provisions of Section 1864(a) of the Act and 42 C.F.R. § 401.133(a). As such, the PoC should not contain personal identifiers, such as patient names, and you may wish to avoid the use of staff names. It must, however, be specific as to what corrective action the hospital will take to achieve compliance, as indicated above. If you believe this notice of findings that Newark Beth Israel Medical Center and Newark Beth Israel Medical Center- Transplant Hospital does not comply with the Medicare Conditions of Participation for hospitals is incorrect, you may request an informal reconsideration. If you wish to do so, please write me at the email address below within 15 days of receipt of this letter. You should state why you consider the finding to be incorrect and you should submit any evidence and arguments which you may wish to bring to our attention. A request for an informal reconsideration does not relieve you of your responsibility to timely submit the aforementioned plan of correction. We thank you for your cooperation and attention to this matter. If you have any questions, please contact me at (215) 861-4180 or via email at Roxanne.Rocco@cms.hhs.gov . Sincerely, Roxanne Rocco Manager, Northeast Acute & Continuing Care Branch Survey & Operations Group Northeast Survey & Enforcement Division Centers for Medicare & Medicaid Services Enclosure: CMS-2567s cc: The New Jersey Department of Health The Joint Commission