Department of Health 8: Hum an Services Centers for Medimre 8: Medicaid Services JFK Federal Building, Govemm ent Center Room 2325 Bostm, MA 02203 CMS MEDICARE MEDICAID SERVICES Northeast Division of Survey 8: Certi?cation August 23, 2016 Dr. Edward Benz, Jr, MD, President CEO Dana-Farber Cancer Institute 450 Brookline Avenue Boston, MA 02115 Re: CMS Certi?cation Number: 220162 Survey ID: EQSF11, 08/04/2016 Initial Notice of Termination Dear Dr. Benz: Section 1865 of the Social Security Act (the Act) and Centers for Medicare Medicaid Services (CMS) regulations provide that a provider or supplier accredited by a CMS-approved Medicare accreditation program will be ?deemed" to meet all of the Medicare Conditions of Participation (CoPs) for hospitals. In accordance with Section 1864 of the Act, State Survey Agencies may conduct at direction, surveys of deemed status providers on a selective sampling basis, in response to a substantial allegation of noncompliance, or when CMS determines a full survey is required after a substantial allegation survey identifies substantial noncompliance. CMS uses such surveys as a means of validating the accrediting organization?s survey and accreditation process. A survey conducted by the Massachusetts Department of Public Health, Division Of Health Care Facility Licensure (State Survey Agency), at Dana-Farber Cancer Institute on August 4, 2016 found that the facility was not in substantial compliance with the following CoPs for hospitals: 42 CFR 482.12 - Governing Body 42 CFR 482.13 - Patient Rights 42 CFR 482.21 - Quality Assessment and Performance Improvement 42 CFR 482.22 - Medical Staff 42 CFR 482.23 - Nursing Services 42 CFR 482.24 - Medical Record Services As a result, effective August 4, 2016, your deemed status has been removed and survey jurisdiction has been transferred to the State Survey Agency. Page 2 - Dr. Edward Benz, Jr, MD, President CEO A listing of all deficiencies found is enclosed (Form CMS-2567, Statement of De?ciencies and Plan of Correction). When a hospital, regardless of whether it has deemed status, is found to be out of compliance with the CoPs, a determination must be made that the facility no longer meets the requirements for participation as a provider or supplier of services in the Medicare program. Such a determination has been made in the case of Dana-Farber Cancer Institute and accordingly, the Medicare agreement between Dana-Farber Cancer Institute and CMS is being terminated. The date on which the Medicare agreement terminates is November 21, 2016. The Medicare program will not make payment for services furnished to patients who are admitted on or after November 21, 2016. For inpatients admitted prior to November 21, 2016, payment may continue to be made for a maximum of 30 days of inpatient services furnished on or after November 21, 2016. You should submit as soon as possible, a list of names and Medicare claim numbers of beneficiaries in your facility on November 21, 2016 to Charles Reynolds, Federal Building, Room 2325, Boston, MA, 02203 to facilitate payment for services to these individuals. We will publish a public notice in the Boston Globe at least fifteen days prior to the termination date. Termination can only be averted by correction of the deficiencies, through submission of an acceptable plan of correction (P00) and subsequent verification of compliance by the State Survey Agency. The Form OMS-2567 with your dated and signed by your facility's authorized representative, must be submitted to the State Survey Agency no later than September 9, 2016. Please indicate your corrective actions on the right side of the Form CMS-2567 in the column labeled ?Provider Plan of Correction?, keying your responses to the de?ciencies on the left. Additionally, indicate your anticipated completion dates in the column labeled ?Completion Date?. Please send your plan of correction to: State Survey Agency (By E-mail) An acceptable must contain the following elements: 1. The plan for correcting each speci?c de?ciency cited; 2. The plan for improving the processes that led to the de?ciency cited, including how the hospital is addressing improvements in its systems in order to prevent the likelihood of recurrence of the de?cient practice; Page 3 Dr. Edward Benz, Jr, MD, President CEO 3. The procedure for implementing the if found acceptable, for each de?ciency cited; 4. A completion date for correction of each de?ciency cited; 5. The monitoring and tracking procedures that will be implemented to ensure that the is effective and that the speci?c de?ciencies cited remain corrected and in compliance with regulatory requirements; and 6. The title of the person(s) responsible for implementing the acceptable Copies of the Form OMS-2567, including copies containing the facility?s 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 P00 should not contain personal identi?ers, 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 an acceptable P00 is timely submitted, your facility will be revisited to verify necessary corrections. If CMS determines that the reasons for termination remain, you will be so informed in writing, including the effective date of termination. If corrections have been made and your facility is in substantial compliance, the termination procedures will be halted, and you will be noti?ed in writing. If your Medicare agreement is terminated and you wish to be readmitted to the program, you must demonstrate to the State Survey Agency and CMS that you are able to maintain compliance. Readmission to the program will not be approved until CMS is reasonably assured that you are able to sustain compliance. If your Medicare agreement is terminated and you do not believe this termination decision is correct, you may request a hearing before an Administrative Law Judge (ALJ) of the Department of Health and Human Services, Departmental Appeals Board. Procedures governing this process are set out in regulations at 42 C.F.R. Part 498. An appeal/request for hearing must be filed no later than sixty (60) calendar days from the date of receipt of the initial notice of termination. You must ?le your appeal electronically at the Departmental Appeals Board Electronic Filing System Web site (DAB E-File) at unless you have received approval from the Civil Remedies Division (CRD) to ?le in hardcopy. It is important that you also send a copy of your request for hearing to this office to the attention of: Survey Branch, Northeast Consortium Division of Survey Certi?cation, Centers for Medicare and Medicaid Services (CMS), JFK Federal Building, Room 2275, Government Center, Boston, MA 02203. A request for a hearing should identify the Page 4 - Dr. Edward Benz, Jr, MD, President CEO speci?c issues, the ?ndings of fact and the conclusions of law, if applicable, with which you disagree. You may be represented by counsel at a hearing at your own expense. If you have any questions, please contact Charles Reynolds at (617) 565-9156. Sincerely, F) J. William Roberson Associate Regional Administrator Northeast Division, Survey Certification Enclosure: Form OMS-2567 cc: State Survey Agency Joint Commission PRINTED: 08/2312016 DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED CENTERS FOR MEMCARE MEDICAID SERVICES NO. 0938?0391 STATEMENT OF DEFICIENCIES (X1) (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A. BUILDING COMPLETED 2201 62 3- WING 08I04I201 6 NAME OF PROVIDER OR SUPPLIER STREET ADDRESS. CITY, STATE. ZIP CODE 450 BROOKLINE AVENUE DANA-FARBER CANCER INSTITUTE BOSTON, MA 02115 (x4) ID SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDERS PLAN OF CORRECTION (x5) (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION TAG REGULATORY OR LSC IDENTIFYING INFORMATION) TAG CROSS-REFERENCED TO THE APPROPRIATE DATE DEFICIENCY) A 000 INITIAL COMMENTS A 000 A CMS authorized complaint survey was conducted (ACTS Reference Number MA00025139) on 8/1, 8/2, 8/3 and 8/4/16 at: Dana-Farber Cancer Institute 450 Brookline Avenue Boston, MA 02115 The following Conditions of Participation were reviewed and were found not to be met. Governing Body CFR 482.12 Patient Rights CFR 482.13 Quality Assessment and Performance Improvement CFR 482.21 Medical Staff CFR 482.22 Nursing Services CFR 482.23 Medical Record Services 482.24 The survey was conducted using a sample of 14 patient records. A043 482.12 GOVERNING BODY A043 There must be an effective governing body that is legally responsible for the conduct of the hospital. If a hospital does not have an organized governing body, the persons legally responsible for the conduct of the hospital must carry out the functions speci?ed in this part that pertain to the governing body This CONDITION is not met as evidenced by: Based on interviews, a review of meeting minutes, Hospital #1?s Medical Staff Bylaws Rules and Regulations. Hospital #1 ?s policies and procedures, the Amended and Restated Adult Oncology Inpatient Clinical Services Agreement, LABORATORY OR REPRESENTATIVES SIGNATURE TITLE (X6) DATE Any de?ciency statement ending with an asterisk denotes a de?ciency which the institution may be excused from correcting providing it is determined that other safeguards provide suf?cient protection to the patients. (See instructions.) Except for nursing homes. the ?ndings stated above are disclosable 90 days following the date of survey whether or not a plan of correction is provided. For nursing homes, the above ?ndings and plans of correction are disclosable 14 days following the date these documents are made available to the facility. If de?ciencies are cited, an approved plan of correction is requisrte to contInued program participation. FORM Previous Versions Obsolete Event ID: EQSF11 Facility ID: 2335 If continuation sheet Page 1 of 37 DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MQICARE MEDICAID SERVICES PRINTED: 08/23/2016 FORM APPROVED OMB NO. 0938-0391 contracted services and a review of the physician credentialing process, the Governing Body of Hospital #1 failed to establish or maintain a separate and distinct Hospital from Hospital The Conditions of Participation were integrated with Hospital therefore, the Condition of Participation of Governing Body was not met. Failure to provide the independent oversight by Hospital #1 placed all potential patients at risk to receive poor quality of care. Findings include: The Governing Body failed to separately and independently examine the credentials and privileges to providers requesting membership or privileges to the medical staff of Hospital Please refer to A 341 The Governing Body failed to assess that all services provided under contract were separately and independently reviewed by the Governing Body to ensure quality care. Please refer to A 263 and A 273 The Governing Body failed to separately and independently approve policies and procedures governing care provided to patients. Please refer to A 118, A 398 and A 409 The Governing body failed to ensure that patients' rights were met. Refer to A 116 The Governing Body failed to ensure that Hospital STATEMENT OF DEFICIENCIES (X1) (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY AND PLAN OF CORRECTION IDENTIFICATION NUMBER: COMPLETED A. BUILDING 220162 8- WING 08I04I2016 NAME OF PROVIDER OR SUPPLIER STREET ADDRESS. CITY. STATE, ZIP CODE 450 BROOKLINE AVENUE DANA-FARBER CANCER INSTITUTE BOSTON, MA 02115 W, .0 SUMMARY STATEMENT OF DEFICIENCIES ID PLAN OF CORRECTION (st PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION TAG REGULATORY OR IDENTIFYING INFORMATION) TAG CROSS-REFERENCED To THE APPROPRIATE DAVE A 043 Continued From page 1 A 043 FORM Previous Versions Obsolete Event ID: EQSF11 Facility ID: 2335 If continuation sheet Page 2 of 37 DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE MEDICAID SERVICES PRINTED: 08/23/2016 FORM APPROVED OMB NO. 0938-0391 STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) IDENTIFICATION NUMBER: 220162 (X2) MULTIPLE CONSTRUCTION A. BUILDING B. WING (x3) DATE SURVEY COMPLETED 08I04I2016 NAME OF PROVIDER OR SUPPLIER DANA-FARBER CANCER INSTITUTE STREET ADDRESS. CITY. STATE, ZIP CODE 450 BROOKLINE AVENUE BOSTON, MA 02115 (X4) ID PREFIX TAG SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) ID PREFIX TAG PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DATE (X5) COMPLETION A 043 A 083 A115 Continued From page 2 #1 had a medical record service that was separate from Hospital Refer to A-431 482.12(e) CONTRACTED SERVICES The governing body must be responsible for services furnished in the hospital whether or not they are furnished under contracts. The governing body must ensure that a contractor of services (including one for shared services and joint ventures) furnishes services that permit the hospital to comply with all applicable conditions of participation and standards for the contracted services. This STANDARD is not met as evidenced by: Based on records reviewed and interviews, for 14 of 14 sampled patients, the Governing Body failed to ensure that services provided under contact and/or agreement were separate and independent from Hospital #2 to ensure care was provided safely and independently from Hospital Findings include: Refer to A 263 482.13 PATIENT RIGHTS A hospital must protect and promote each patient's rights. This CONDITION is not met as evidenced by: Based on observations, records reviewed and interviews, the Hospital failed for 3 of 14 sampled patients (Pt #12 and to have patient rights information and complaint/grievance A 043 A 083 A115 FORM Previous Versions Obsolete Event ID: EQSF11 Facility ID: 2335 If continuation sheet Page 3 of 37 DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION PRINTED: 08/23/2016 FORM APPROVED OIVIB NO. 0938?0391 (X1) IDENTIFICATION NUMBER: 220162 (X2) MULTIPLE CONSTRUCTION A. BUILDING B. WING (X3) DATE SURVEY COMPLETED 08I04I2016 NAME OF PROVIDER OR SUPPLIER DANA-FARBER CANCER INSTITUTE STREET ADDRESS. CITY. STATE, ZIP CODE 450 BROOKLINE AVENUE BOSTON, MA 02115 (X4) ID PREFIX TAG SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) ID PREFIX TAG PLAN OF CORRECTION (x5) (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DATE COMPLETION A115 A116 Continued From page 3 policies that were independent from Hospital #2 and exclusive for patients of Hospital Findings include: Hospital #1's Complaint Policy and Procedure regarding patient complaints and grievances, dated 2/2016, indicated that Hospital #1 's policy excluded complaints from Hospital #1's inpatient units (5A, 5B and 6C). Hospital #1 used Hospital #25 policy and procedure regarding complaints for Hospital #1 's inpatients without appropriately adopting Hospital #25 policy and procedures. Hospital #1 '3 Welcome Packet, provided to Hospital #1 's inpatient units 5A, 5B and 60 have the name and logo of Hospital #2 on the booklet. Please refer to A-116 482.13(a) PATIENT RIGHTS: NOTICE OF RIGHTS Patients' Rights: Notice of Rights This STANDARD is not met as evidenced by: Based on observations, records reviewed and interviews, for 3 of 14 sampled patients (Pt #12 and Hospital #1 failed to separately and independently inform all patients of their rights. Findings include: During a tour of 60 on 8/1/16, the Surveyor observed 10 of Hospital #1's 30 licensed inpatient A115 A116 FORM Previous Versions Obsolete Event ID: EQSF11 Facility ID: 2335 If continuation sheet Page 4 of 37 DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION PRINTED: 08/23/2016 FORM APPROVED OMB NO. 0938-0391 (X1) IDENTIFICATION NUMBER: 220162 (X2) MULTIPLE CONSTRUCTION A. BUILDING B. WING (X3) DATE SURVEY COMPLETED 08I04I2016 NAME OF PROVIDER OR SUPPLIER DANA-FARBER CANCER INSTITUTE STREET ADDRESS. CITY. STATE. ZIP CODE 450 BROOKLINE AVENUE BOSTON, MA 02115 Nurse Director said she was not sure, but she beds. The ten rooms were numbered 51-60 and those patient beds were within the building of Hospital The Surveyor interviewed the Access Services Manager, employed by Hospital at 10:30 AM. on 8/4/16. Hospital #2's Access Services Manager said that for planned admissions, Hospital #2's Welcome Packet would be mailed to a patient by Hospital not Hospital Hospital #2's Access Services Manager said for those patients with an unplanned admission to Hospital #1's unit 5A. SB and 60, Hospital #2's Access Staff would go directly to Hospital #1 inpatient units and ensure those patients receive Hospital #2's Welcome Packet. During the tour, the Surveyor interviewed Patient #6 at approximately 2:00 PM. Patient #6 said he/she did not receive a copy of patient rights and was not informed how to ?le a complaint if he/she needed to ?le one. The Surveyor interviewed Hospital #2's Nurse Director during the tour of 60 on 8/1/16. The thought the Patient?s Rights were given to patients when they checked into the Admitting Of?ce or the Patient Rights were mailed to patients by the Admitting Of?ce of Hospital During a second tour of 6C at 9:50 AM. on 8/4/16, the Surveyor interviewed Patient #12. Patient #12 said he/she did not receive a copy of his/her rights as a Hospital #1 patient. The Surveyor interviewed Patient #13 at 10:00 (x4) .9 SUMMARY STATEMENT OF DEFICIENCIES lD PLAN OF CORRECTION (x5) (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION TAG REGULATORY OR LSC IDENTIFYING INFORMATION) TAG CROSS-REFERENCED TO THE APPROPRIATE DATE A116 Continued From page 4 A 116 FORM Previous Versions Obsolete Event ID: EQSF11 Facility ID: 2335 If continuation sheet Page 5 of 37 DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE MEDICAID SERVICES PRINTED: 08/23/2016 FORM APPROVED OMB NO. 0938-0391 The hospital must establish a process for prompt resolution of patient grievances and must inform each patient whom to contact to ?le a grievance. This STANDARD is not met as evidenced by: Based on records reviewed and interviews, for 3 of 14 sampled patients (Patient #12 and Hospital #1 failed to have complaint and grievance policies that were independent from Hospital #2 and were exclusive for the Patients at Hospital Finding include: Hospital #1's policy and procedure titled Patient ComplaintiGrievance/Request Management Process, dated 2/2016, indicated Hospital #1 developed a policy and procedure that excluded Hospital #1's inpatient units, 5A, SB and 6C. Hospital #1 ?s policy and procedure titled Patient Complaint/Grievance/Request Management Process, dated 2/2016, indicated that every effort will be made to resolve a grievance in 7 days and provide a written response of resolution to the STATEMENT OF DEFICIENCIES (X1) (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A. BUILDING COMPLETED 220162 B. WING 08/04/2016 NAME OF PROVIDER OR SUPPLIER STREET ADDRESS. CITY. STATE, ZIP CODE 450 BROOKLINE AVENUE DANA-FARBER CANCER INSTITUTE BOSTON, MA 02115 (x4) .0 SUMMARY STATEMENT OF DEFICIENCIES Io PLAN OF CORRECTION (x5) PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION TAG REGULATORY OR LSC IDENTIFYING INFORMATION) TAG CROSS-REFERENCED TO THE APPROPRIATE DATE A 116 Continued From page 5 A 116 AM. on 8/4/16. Patient #13 said he/she did not receive a copy of his/her rights as a Hospital #1 patient. During both tours of SC on 8/1 and 8/3/16, the Surveyor observed and reviewed Patient #12 and #13's medical records that were in a binder type note book as well as their electronic record. Patient #12 and #13's medical record did not indicate that Hospital #1 informed Patient #12 and #13 of their Patient Rights and Responsibilities. A 118 PATIENT RIGHTS: GRIEVANCES A118 FORM Previous Versions Obsolete Event ID: EQSF11 Facility ID: 2335 If continuation sheet Page 6 of 37 DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE SERVICES PRINTED: 08/23/2016 FORM APPROVED OMB NO. 0938-0391 complainant. The policy indicated that if a resolution was not possible in 7 days, then it was resolved within 30 business days. The Surveyor interviewed Hospital#1's Patient and Family Program Manager at 8:30 AM. on 8/3/16. The Patient and Family Program Manager said that that she was responsible for coordinating outpatient complaints and responding back to complainants. The Patient and Family Program Manager said that the complaints for the inpatients are the responsibility of staff at Hospital The Surveyor reviewed four patient complaints, dated from January 2016 to July 2016. The investigations from the outpatient complaints did not include a written response of resolution as required by Hospital #1's policy and procedure. The two complaints from the inpatient log were in a ?le that belonged to Hospital The Surveyor reviewed Hospital #1 's Complaint Log, dated January 2016 to July 2016, two complaints from the Outpatient Log and two complaints from the Inpatient Log were reviewed. Hospital #1's Complaint Log indicated three complaints were not resolved within 30 business days as indicated in Hospital #1's policy and procedure. Further review of Hospital #1's policy and procedure titled "Patient Complaint/Grievance/Request Management Process", dated 2/2016. did not contain the procedure of how a patient was to contact the Quality Improvement Organization if they had a complaint regarding quality of care or disagree STATEMENT OF DEFICIENCIES (X1) (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY AND PLAN OF CORRECTION IDENTIFICATION NUMBER: COMPLETED A. BUILDING 0 220162 3- 08I04I2016 NAME OF PROVIDER OR SUPPLIER STREET ADDRESS. CITY. STATE, ZIP CODE 450 BROOKLINE AVENUE DANA-FARBER CANCER INSTITUTE BOSTON, MA 02115 (x4) ID SUMMARY STATEMENT OF DEFICIENCIES lD PLAN OF CORRECTION (x5) paenx (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION TAG REGULATORY OR LSC IDENTIFYING INFORMATION) TAG CROSS-REFERENCED TO THE APPROPRIATE DATE A 118 Continued From page 6 A118 FORM Previous Versions Obsolete Event ID: EQSF11 Facility ID: 2335 If continuation sheet Page 7 of 37 DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE MEDICAID SERVICES PRINTED: 08/23/2016 FORM APPROVED OMB N0. 0938-0391 STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) IDENTIFICATION NUMBER: 2201 62 (X2) MULTIPLE CONSTRUCTION A. BUILDING B. WING (X3) DATE SURVEY COMPLETED 6 NAME OF PROVIDER OR SUPPLIER DANA-FARBER CANCER INSTITUTE STREET ADDRESS. CITY. STATE. ZIP CODE 450 BROOKLINE AVENUE BOSTON, MA 02115 (X4) ID PREFIX TAG SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) ID PREFIX TAG PLAN OF CORRECTION (x5) (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DATE DEFICIENCY) COMPLETION A118 A 263 Continued From page 7 with a coverage decision (for example discharge). 482.21 QAPI The hospital must develop, implement and maintain an effective, ongoing, hospital-wide, data-driven quality assessment and performance improvement program. The hospital's governing body must ensure that the program re?ects the complexity of the hospital's organization and services; involves all hospital departments and services (including those services furnished under contract or arrangement); and focuses on indicators related to improved health outcomes and the prevention and reduction of medical errors. The hospital must maintain and demonstrate evidence of its QAPI program for review by CMS. This CONDITION is not met as evidenced by: Based on record review and interviews, Hospital #1 failed to have its own exclusive Quality Assessment/Performance Improvement Program (QAPI) that was independent from Hospital #2 to ensure the quality of services for the patients of Hospital Findings included: 1. Based on records reviewed and interviews, Hospital #1 failed to have an independent Quality Assurance Performance Improvement (QAPI) Plan that: measured, analyzed and tracked quality indicators and other aspects of performance and that assessed processes of A118 A 263 FORM Previous Versions Obsolete Event ID: EQSF11 Facility ID: 2335 If continuation sheet Page 8 of 37 DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION PRINTED: 08/23/2016 FORM APPROVED N0. 0938-0391 (X1) IDENTIFICATION NUMBER: 220162 (X2) MULTIPLE CONSTRUCTION A. BUILDING B. WING (x3) DATE SURVEY COMPLETED 08l04l201 6 NAME OF PROVIDER OR SUPPLIER DANA-FARBER CANCER INSTITUTE STREET ADDRESS. CITY. STATE, ZIP CODE 450 BROOKLINE AVENUE BOSTON, MA 02115 (x4) ID PREFIX TAG SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) ID PREFIX TAG PLAN OF CORRECTION (x5) (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DATE COMPLETION A 263 Continued From page 8 care, hospital service and operations, de?ned and incorporated quality indicator data according to de?nitions of the Governing Body that speci?ed the frequency and detail of the data collection and monitored the effectiveness and safety of services and quality of care. See A 273 2. Based on records reviewed and interviews, Hospital #1 failed to take actions through the hospital's QAPI program to: assess those services provided under contract, identify quality and performance problems, implement appropriate corrective or improvement activities and ensure the monitoring and sustainability of those corrective or improvement activities. See A 308 3. Based on records reviewed and interviews, Hospital #1 failed to have an independent QAPI program that: identi?ed and reduced medical errors and adverse patient events, analyzed their causes and implemented preventative actions and mechanisms that included feedback and learning throughout Hospital See A 286 4. Based on records reviewed and interviews, Hospital #1 failed to: have a performance improvement program separate from Hospital #2 whose efforts addressed priorities for improved quality of care and patient safety, ensure that all improvement actions were evaluated and failed to determine the number of distinct improvement projects that would be conducted annually. A 263 FORM Previous Versions Obsolete Event ID: EQSF11 Facility ID: 2335 If continuation sheet Page 9 of 37 DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE MEDICAIDLSERVICES PRINTED: 08/23/2016 FORM APPROVED OMB NO. 0938-0391 STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) IDENTIFICATION NUMBER: 2201 62 (X2) MULTIPLE CONSTRUCTION A. BUILDING B. WING (X3) DATE SURVEY COMPLETED 08I04l201 6 NAME OF PROVIDER OR SUPPLIER DANA-FARBER CANCER INSTITUTE STREET ADDRESS. CITY. STATE, ZIP CODE 450 BROOKLINE AVENUE BOSTON, MA 02115 (X4) ID PREFIX TAG SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) ID PREFIX TAG PLAN OF CORRECTION (x5) (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DATE DEFICIENCY) COMPLETION A 263 A 273 measure, assess, improve and sustain Hospital #1 's performance and reduce risks to patients. Continued From page 9 See A 309 5. Based on records reviewed and interviews, Hospital #1 failed to allocate hospital resources to Instead Hospital #1 relied upon Hospital its contracted service, to perform these functions and took no independent responsibility to see that quality and performance improvement were maintained and sustained. See A 315 DATA COLLECTION 8: ANALYSIS Program Scope (1) The program must include, but not be limited to, an ongoing program that shows measurable improvement in indicators for which there is evidence that it will improve health outcomes (2) The hospital must measure, analyze, and track quality indicators and other aspects of performance that assess processes of care, hospital service and operations. (b)Program Data (1) The program must incorporate quality indicator data including patient care data, and other relevant data, for example, information submitted to, or received from, the hospital's Quality Improvement Organization. (2) The hospital must use the data collected to-- Monitor the effectiveness and safety of services and quality of care; and (3) The frequency and detail of data collection must be speci?ed by the hospital?s governing A 263 A 273 FORM Previous Versions Obsolete Event ID: EQSF11 Facility ID: 2335 If continuation sheet Page 10 of 37 DEPARTMENT OF HEALTH AND HUMAN SERVICES PRINTED: 08/23/2016 FORM APPROVED CENTERS FOR MEDICARE MEDICAID SERVICES OMB No. 0938-0391 STATEMENT OF DEFICIENCIES (X1) (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A. BUILDING COMPLETED 220162 3- 08l04l2016 NAME OF PROVIDER OR SUPPLIER DANA-FARBER CANCER INSTITUTE STREET ADDRESS. CITY. STATE. ZIP CODE 450 BROOKLINE AVENUE BOSTON, MA 02115 (X4) ID PREFIX TAG SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) ID PREFIX TAG PLAN OF CORRECTION (x5) (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DATE DEFICIENCY) A 273 Continued From page 10 body. This STANDARD is not met as evidenced by: Based on record review and interview, Hospital #1 failed to have an independent Quality Assurance Performance Improvement (QAPI) Plan that: measured, analyzed and tracked quality indicators and other aspects of performance and that assessed processes of care, hospital service and operations, de?ned and incorporated quality indicator data according to de?nitions of the Governing Body that speci?ed the frequency and detail of the data collection and monitored the effectiveness and safety of services and quality of care. Findings included: 1. Review of Hospital #1's Quality Improvement Plan and Quality Assurance contract with Hospital #2 did not identify any indicators of quality or aspects of performance for monitoring and evaluation regarding Hospital Review of the inpatient clinical sen/ices agreement, updated in April 2016, indicated Hospital #1 contracted with Hospital #2 to jointly provide Quality Assurance to facilitate achievement of excellence in clinical care delivery in the inpatient clinical units using a reliance on a partnership with the clinical and administrative leaders of Hospital #2 to prioritize, support, lead and evaluate clinical improvement activities. Hospital #2 would provide program structure such as quality measurement, reporting and A 273 FORM Previous Versions Obsolete Event ID: EQSF11 Facility ID: 2335 If continuation sheet Page 11 of 37 DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEQICARE MEDICAID SERVICES PRINTED: 08/23/2016 FORM APPROVED NO. 0938-0391 STATEMENT OF DEFICIENCIES (X1) AND PLAN OF CORRECTION IDENTIFICATION NUMBER: 2201 62 (X2) MULTIPLE CONSTRUCTION A. BUILDING B. WING (X3) DATE SURVEY COMPLETED (18/04/201 6 NAME OF PROVIDER OR SUPPLIER DANA-FARBER CANCER INSTITUTE STREET ADDRESS. CITY, STATE. ZIP CODE 450 BROOKLINE AVENUE BOSTON, MA 02115 (x4) .0 SUMMARY STATEMENT OF DEFICIENCIES pREle (EACH DEFICIENCY MUST BE PRECEDED BY FULL TAG REGULATORY OR LSC IDENTIFYING INFORMATION) ID PREFIX TAG PLAN OF CORRECTION (X5) (EACH CORRECTIVE ACTION SHOULD BE COMPLETION CROSS-REFERENCED TO THE APPROPRIATE DATE DEFICIENCY) A273 Continued From page 11 improvement, patient safety teams, performance improvement and decision support and internal and external reporting. Hospital #2 would serve as a member on Hospital #1's Joint Committee on Quality Improvement and Risk Management (JQRIM) and on Hospital #1's Quality Leadership Council. Under the agreement, Hospital #2 would de?ne and measure key performance indicators of quality, safety and operations of Hospital #1's inpatient population. Hospital #2 would oversee safety reporting systems, safety culture and just culture systems and would facilitate performance improvement projects. Metrics were to be sent to Hospital #1's Quality Improvement Department to compile and present to the Quality Leader Council group which is a sub-committee of the board level JQRIM committee. The Surveyor review the minutes of the Quality Leadership Council, dated 7/3/2015 and 12/3/2015 (January 3, 2016 meeting minutes were requested but not provided). In the 12/3/2015 minutes, under Quality Improvement, results of a Press Ganey Survey (patient satisfaction survey) were discussed that re?ected combined survey results of both Hospital #1 and Results indicated that the inpatient pods of Hospital #1 were performing as a lower rate when compared to inpatient pods at Hospital #2 regarding the patients overall rating the hospital, recommendation of the hospital and communication with nurses and doctors. The minutes indicated an internal investigation was ongoing to determine why there was a difference between Hospital #1 and Hospital #25 inpatient pods satisfaction rates. The next steps would be an internal improvement process. There was no A 273 FORM Previous Versions Obsolete Event ID: EQSF11 Facility ID: 2335 If continuation sheet Page 12 of 37 DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICAID SERVICES PRINTED: 08/23/2016 FORM APPROVED OMB NO. 0938-0391 . further documentation to indicate that a performance improvement was planned or provided. The Joint Committee on Quality Improvement and Risk Management minutes indicated that under data and performance measures, review of dashboard quarterly reported data focused on patient experience, patient events (falls with injury) and the integrated electronic health record as well as pediatric satisfaction scores from the outpatient and associated oncology services from other hospitals. It also indicated that a quick review of a "more detailed quarterly departmental report" was reportedly done with no other areas requiring a focused review. The Joint Committee on Quality Improvement and Risk Management minutes indicated the 2015 Infection Control Plan data was not available for presentation at that time and only staff ?u vaccination compliance was reviewed. When the Surveyor requested quarterly data for just the inpatient pods of Hospital it took three days after the request for Hospital #1 to produce the data. During an interview on 8/3/2016 at 8:00 AM, Hospital #1's Risk Manager said that the data was combined with Hospital #25 but could be separated down to each pod for Hospital When the quarterly department report was received there was no data recorded for Hospital #1 since October 2015 for the areas of care coordination, nursing oncology, blood transfusion standards, central venous line related bacteremia. management of chemotherapy side effects, hand hygiene compliance, pain management to include completion of pain STATEMENT OF DEFICIENCIES (X1) (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A BUILDING COMPLETED 0 220162 3- 08/04/2016 NAME OF PROVIDER OR SUPPLIER STREET ADDRESS. CITY. STATE. ZIP CODE 450 BROOKLINE AVENUE DANA-FARBER CANCER INSTITUTE BOSTON, MA 02115 (x4) ID SUMMARY STATEMENT OF DEFICIENCIES ID PLAN OF CORRECTION (x5) 13125le (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION TAG REGULATORY OR LSC IDENTIFYING INFORMATION) TAG CROSS-REFERENCED TO THE APPROPRIATE DATE DEFICIENCY) A 273 Continued From page 12 A 273 FORM Previous Versions Obsolete Event ID: EQSF11 Facility ID: 2335 If continuation sheet Page 13 of 37 DEPARTMENT OF HEALTH AND HUMAN SERVICES PR'ygEazAgs?faw?g CENTERS FOR MEDICARE MEDICAID SERVICES OMB NO. 0938-0391 STATEMENT OF DEFICIENCIES (X1) (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A. BUILDING COMPLETED 0 220162 08l04l2016 NAME OF PROVIDER 0R SUPPLIER STREET ADDRESS. CITY. STATE. ZIP CODE 450 BROOKLINE AVENUE BOSTON, MA 02115 (x4) ID SUMMARY STATEMENT OF DEFICIENCIES ID PLAN OF CORRECTION (x5) PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION TAG REGULATORY OR LSC IDENTIFYING INFORMATION) TAG CROSS-REFERENCED TO THE APPROPRIATE DATE DEFICIENCY) DANA-FARBER CANCER INSTITUTE A273 Continued From page 13 A273 assessments, nutrition, and pharmacy measures to include median time to drug availability. There was no Catheter Associated Urinary Tract Infection (CAUTI) data since April 2015. Review of the JQRIM (Governing Body level review) minutes through 7/2016 did not indicate any mention of performance improvement activities related to the Press Ganey results of patient satisfaction on the inpatient pods. A 286 482.21 PATIENT SAFETY A 286 Standard: Program Scope (1) The program must include, but not be limited to, an ongoing program that shows measurable improvement in indicators for which there is evidence that it.will identify and reduce medical errors. (2) The hospital must measure, analyze, and track patient events Program Activities (2) Performance improvement activities must track medical errors and adverse patient events, analyze their causes, and implement preventive actions and mechanisms that include feedback and learning throughout the hospital. Executive Responsibilities, The hospital's governing body (or organized group or individual who assumes full legal authority and responsibility for operations of the hospital), medical staff, and administrative of?cials are responsible and accountable for ensuring the following: (3) That clear expectations for safety are established. FORM Previous Versions Obsolete Event ID: EQSF11 Facility ID: 2335 If continuation sheet Page 14 of 37 DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE MEDICAID SERVICES PRINTED: 08/23/2016 FORM APPROVED OVIB NO. 0938-0391 This STANDARD is not met as evidenced by: Based on records reviewed and interviews, the Hospital failed to have an independent QAPI program that identi?ed and reduced medical errors and adverse patient events, analyzed their causes and implemented preventative actions and mechanisms that included feedback and learning throughout the hospital. Findings included: Hospital #1 contracted with Hospital #2 to identify serious and/or unexpected patient outcomes through mechanisms such as safety reporting systems, quality measurement reports, medical record reviews and provider reports. Sentinel events would be reviewed by both Hospital #1 and Hospital #25 Risk Management (RM) staff and hospital committees to ensure that any and all necessary external reporting was completed per regulatory requirements under Hospital #1?s license. Hospital #2 would serve as a member on Hospital #1's Medical Staff Executive Committee (MSEC), the combined Quality Improvement Committee and various other safety committees. Hospital #2 would also report to Oncology leadership (made up of members from both Hospital #1 and Hospital on falls, medication events (these metrics are reported to the Care Improvement Team and to the Joint team) and SRE's (Serious Reportable Events), which are reported to the Joint Committee. Review of the Joint Committee on Quality Improvement and Risk Management (JQIRM) STATEMENT OF DEFICIENCIES (X1) (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A BUILDING COMPLETED 220162 3- 08IO4I2016 NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY. STATE. ZIP CODE 450 BROOKLINE AVENUE DANA-FARBER CANCER INSTITUTE BOSTON, MA 02115 (x4) ID SUMMARY STATEMENT OF DEFICIENCIES ID PLAN OF CORRECTION (x5) PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION TAG REGULATORY OR LSC IDENTIFYING INFORMATION) TAG CROSS-REFERENCED TO THE APPROPRIATE DATE DEFICIENCY) A 286 Continued From page 14 A 286 FORM Previous Versions Obsolete Event ID: EQSF11 Facility ID: 2335 If continuation sheet Page 15 of 37 DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE MEDICAID SERVICES PRINTED: 08/23/2016 FORM APPROVED OMB NO. 0938-0391 STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (x1) IDENTIFICATION NUMBER: 220162 (X2) MULTIPLE CONSTRUCTION A. BUILDING B. WING (x3) DATE SURVEY COMPLETED 6 NAME OF PROVIDER OR SUPPLIER DANA-FARBER CANCER INSTITUTE STREET ADDRESS. CITY. STATE, ZIP CODE 450 BROOKLINE AVENUE BOSTON, MA 02115 (x4) ID PREFIX TAG SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) ID PREFIX TAG PLAN OF CORRECTION (st (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED To THE APPROPRIATE DATE DEFICIENCY) COMPLETION A 286 A 308 Continued From page 15 committee minutes, 12/18/2015, indicated that the committee was comprised of members from Hospital #1 and Hospital Other events such as Central Line Acquired Blood Stream Infections (CLABSI) and oral chemotherapy safety in the pediatric cancer population was also discussed from three institutions (Hospital #1 Hospital #2 and the pediatric specialty Hospital The JQRIM minutes indicated that the Senior Director of Patient Safety, an employee of Hospital presented to the JQRIM Committee the process on safety reporting in Hospital #23 computerized system. The presentation indicated that the reports were reviewed by department managers, risk management, patient medication safety of?cer at Hospital #2 and if the event caused any level of harm the report is automatically emailed to a senior leadership for review. Root cause analyses were conducted for serious or potentially serious events as well as selected near misses. An internal safety coding team reviewed all reports and standardized the event type and severity level coding. A multidisciplinary review committee which included nurses, pharmacists and representatives from all the relevant clinical areas reviewed the select cases for follow-up and trended data and the data was used to drive improvement. 482.21 QAPI GOVERNING BODY, STANDARD TAG The hospital's governing body must ensure that the program re?ects the complexity of the hospital?s organization and services; involves all hospital departments and services (including those services furnished under contract or arrangement) The hospital must maintain and A 286 A 308 FORM Previous Versions Obsolete Event ID: EQSF11 Facility ID: 2335 lf continuation sheet Page 16 of 37 DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE MEDICAID SERVICES PRINTED: 08/23/2016 FORM APPROVED OIVIB NO. 0938-0391 STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDERISUPPLIERICLIA IDENTIFICATION NUMBER: 2201 62 (X2) MULTIPLE CONSTRUCTION A. BUILDING B. WING (x3) DATE SURVEY COMPLETED 08I04I2016 NAME OF PROVIDER OR SUPPLIER DANA-FARBER CANCER INSTITUTE STREET ADDRESS. CITY. STATE, ZIP CODE 450 BROOKLINE AVENUE BOSTON, MA 02115 (X4) ID PREFIX TAG SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) ID PREFIX TAG PLAN OF CORRECTION (X5) (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DATE DEFICIENCY) COMPLETION A 308 Continued From page 16 demonstrate evidence of its QAPI program for review by CMS. This STANDARD is not met as evidenced by: Based on records reviewed and interviews, Hospital #1 failed to take actions through the hospital's QAPI program to: assess those services provided under contract, identify quality and performance problems, implement appropriate corrective or improvement activities and ensure the monitoring and sustainability of those corrective or improvement activities. Findings included: 1. Review of the list of contracted services provided by Hospital #1 indicated that Hospital #1 had contracted for 33 services from Hospital #2 to include but not limited to: admitting and patient registration, care coordination/utilization review, central processing, clinical compliance and risk management, environmental services, food and dietary services, health information services; human resources; infection prevention and control; information systems, nutrition, patient care plans and nursing services, pharmacy services, physician services, quality assurance, radiology, rehabilitation services and respiratory care services. According to the contracted service agreements, each ?scal year the department was to complete a standardized scorecard detailing performance in their quality metrics for the year and submit it to the Medical Director of Inpatient Medical Oncology Service and the Associate Chief Nurse of Oncology of Hospital This staff would review the scorecards and determine any corrective actions and provide a summary to A 308 FORM Previous Versions Obsolete Event ID: EQSF11 Facility ID: 2335 If continuation sheet Page 17 of 37 DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE MEDICAID SERVICES PRINTED: 08/23/2016 FORM APPROVED OMB NO. 0938-0391 STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) IDENTIFICATION NUMBER: 2201 62 (X2) MULTIPLE CONSTRUCTION A. BUILDING B. WING (X3) DATE SURVEY COMPLETED 08I04I2016 NAME OF PROVIDER OR SUPPLIER DANA-FARBER CANCER INSTITUTE STREET ADDRESS. CITY. STATE. ZIP CODE 450 BROOKLINE AVENUE BOSTON, MA 02115 (X4) ID PREFIX TAG SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) ID PLAN OF CORRECTION PREFIX TAG THE APPROPR DEFICIENCY) (EACH CORRECTIVE ACTION SHOULD BE (X5) COMPLETION IATE DATE A 308 A 309 Continued From page 17 Oncology Leadership at Hospital Each department would be scheduled for an annual report to Oncology Leadership forums, as appropriate, to the service provided. Presentations may be consolidated as needed (for example one consolidated in Patient presentation to JQRIM (Joint Committee on Quality Improvement and Risk Management) by the Medical Director of Inpatient Medical Oncology Service and the Associate Chief Nurse of Oncology from Hospital On 8/3/2016, at 8:00 AM, Hospital #1's senior management team was asked to produce any documentation to indicate that the JQRIM (governing body) had assessed, through its QAPI program, all the contracted services for quality and safety as well as review of performance improvement programs for monitoring and sustainability in those services in the past two years. By the end of the day, the management team was unable to produce the requested information that Hospital #1's QAPI process had independently evaluated all the contracted services. QAPI EXECUTIVE RESPONSIBILITIES The hospital's governing body (or organized group or individual who assumes full legal authority and responsibility for operations of the hospital), medical staff, and administrative of?cials are responsible and accountable for ensuring the following: 1) That an ongoing program for quality improvement and patient safety. including the reduction of medical errors. is de?ned. A 308 A 309 FORM Previous Versions Obsolete Event ID: EQSF11 Facility ID: 2335 If continuation sheet Page 18 of 37 DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE MEDICAID STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION PRINTED: 08/23/2016 FORM APPROVED OMB NO. 0938-0391 (X1) PROVIDERISUPPLIERICLIA IDENTIFICATION NUMBER: 220162 (X2) MULTIPLE CONSTRUCTION A. BUILDING B. WING (X3) DATE SURVEY COMPLETED 08I04I201 6 NAME OF PROVIDER OR SUPPLIER DANA-FARBER CANCER INSTITUTE STREET ADDRESS. CITY, STATE, ZIP CODE 450 BROOKLINE AVENUE BOSTON, MA 02115 (X4) ID PREFIX TAG SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) ID PREFIX TAG PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPR DEFICIENCY) (X5) COMPLETION IATE DATE A 309 Continued From page 18 implemented, and maintained . (2) That the hospital-wide quality assessment and performance improvement efforts address priorities for improved quality of care and patient safety and that all improvement actions are evaluated. (5) That the determination of the number of distinct improvement projects is conducted annually. This STANDARD is not met as evidenced by: Based on records reviewed and interviews, Hospital #1 failed to: have a performance improvement program separate from Hospital #2 whose efforts addressed priorities for improved quality of care and patient safety, ensure that all improvement actions were evaluated and determine the number of distinct improvement projects that would be conducted annually. Findings included: Hospital #1's QAPI plan was requested. A document titled "Quality Improvement Plan", revised in April 2016, indicated that each department is responsible for: reviewing new and existing processes and routines relevant to each performance area, developing, collecting and monitoring key quality indicator to measure performance, assessing and interpreting data collected to formulate recommendations, actions and evaluation, developing activities and processes to comply with external regulatory standard and reporting to appropriate oversight committee on results of quality improvement activities. A 309 FORM Previous Versions Obsolete Event ID: EQSF11 Facility ID: 2335 If continuation sheet Page 19 of 37 DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE MEDICAID SERVICES PRINTED: 08/23/2016 FORM APPROVED OMB NO. 0938-0391 STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) IDENTIFICATION NUMBER: 220162 (X2) MULTIPLE CONSTRUCTION A. BUILDING B. WING (x3) DATE SURVEY COMPLETED 08l04l2016 NAME OF PROVIDER OR SUPPLIER DANA-FARBER CANCER INSTITUTE STREET ADDRESS. CITY. STATE, ZIP CODE 450 BROOKLINE AVENUE BOSTON, MA 02115 (X4) ID PREFIX TAG SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) ID PREFIX TAG PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) (X5) COMPLETION DATE A 309 A315 Continued From page 19 Each department manager was responsible and accountable for monitoring, evaluating and improving the care and services provided by their department and for those contracted services related to the provision of safe oncology care. Managers will ensure that quality improvement data was gathered, aggregated and reported to the appropriate oversight committee for review and corrective action was implemented in a timely manner. The plan did not determine, for each department, what distinct improvement projects would be performed in 2016. The Surveyor interviewed the Associate Chief Nurse for Hospital #2 at 2:00 P.M.on 8/3/2016. The Associate Chief Nurse for Hospital #2 said that performance improvement in nursing quality is done through nursing at Hospital #2 and encompasses the inpatient pods of Hospital All data is collected and evaluated for all patient units including the inpatient areas of Hospital When trends are noted, the nurse managers of the each pod are noti?ed and are asked to address care issues. Each manager of Hospital #1 's inpatient units were employees of Hospital #2 and managed other inpatient units of Hospital Performance improvements for issues such as pressure sores, Catheter Associated Urinary Tract Infections (CAUTI) may be the same for all inpatient units for both hospitals and not speci?c to Hospital The Associate Chief Nurse for Hospital #2 said that nursing quality issues were reviewed at Hospital PROVIDING ADEQUATE RESOURCES A 309 A315 FORM Previous Versions Obsolete Event ID: EQSF11 Facility ID: 2335 If continuation sheet Page 20 of 37 PRINTED: 08/23/2016 DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED CENLERS FOR MQDICARE MEDICAID SERVICES 0le NO. 0938-0391 STATEMENT OF DEFICIENCIES (X1) Ix2) MULTIPLE CONSTRUCTION (x3) DATE SURVEY AND PLAN or CORRECTION IDENTIFICATION NUMBER: BUILDING COMPLETED 220162 8- WING 08/04/2016 NAME OF PROVIDER DR SUPPLIER STREET ADDRESS. CITY, STATE. ZIP CODE 450 BROOKLINE AVENUE DANA-FARBER CANCER TIT NS BOSTON, MA 02115 (x4) .9 SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDERS PLAN OF CORRECTION (st PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION TAG REGULATORY OR LSC IDENTIFYING INFORMATION) TAG CROSS-REFERENCED To THE APPROPRIATE DATE DEFICIENCY) A 315 Continued From page 20 A 315 [The hospital's governing body (or organized group or individual who assumes full legal authority and responsibility for operations of the hospital), medical staff, and administrative of?cials are responsible and accountable for ensuring the following:] (4) That adequate resources are allocated for measuring, assessing, improving, and sustaining the hospital's performance and reducing risk to patients. This STANDARD is not met as evidenced by: Based on records reviewed and interviews, Hospital #1 failed to allocate resources to measure, assess, improve and sustain Hospital #1 '8 performance and reduce risk to patients. Instead Hospital #1 relied upon Hospital its contracted service, to perform these functions and took no independent responsibility to ensure that quality and performance improvement were maintained and sustained. Findings included: Hospital #1 contracted it quality assurance and performance improvement activities to Hospital #2 with little oversight. Hospital #1 had appointed a Director of Quality and a Risk Manager who worked with Hospital Hospital #2 reviewed all patient safety events, conducted investigations and root cause analyses when required which were shared with Hospital Although the Director of Quality and the Risk FORM Previous Versions Obsolete Event ID: EQSF11 Facility ID: 2335 If continuation sheet Page 21 of 37 DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE MEDICAID SERVICES PRINTED: 08/23/2016 FORM APPROVED OMB NO. 0938-0391 STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) IDENTIFICATION NUMBER: 2201 62 (X2) MULTIPLE CONSTRUCTION A. BUILDING B. WING (X3) DATE SURVEY COMPLETED 08IO4I2016 NAME OF PROVIDER OR SUPPLIER DANA-FARBER CANCER INSTITUTE STREET ADDRESS. CITY. STATE, ZIP CODE 450 BROOKLINE AVENUE BOSTON, MA 02115 (x4) ID PREFIX TAG SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) ID PREFIX TAG PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPR DEFICIENCY) (X5) COMPLETION IATE DATE A315 A 338 A341 Continued From page 21 Manager attended Hospital #1's Joint Committee on Quality Improvement and Risk Management (JQRIM) and were members of Hospital #1 '8 Quality Leadership Council, all the data was collected. analyzed and measured by Hospital Hospital the contracted service. presented all the data at these meetings. Performance measures were designed and implemented by Hospital 482.22 MEDICAL STAFF The hospital must have an organized medical staff that operates under bylaws approved by the governing body, and which is responsible for the quality of medical care provided to patients by the hospital. This CONDITION is not met as evidenced by: The Governing Body failed to enforce the Medical Staff Bylaws to ensure that the Bylaws applied equally to all staff as it relates to credentialing and privileging. See A 341 MEDICAL STAFF CREDENTIALING The medical staff must examine the credentials of all eligible candidates for medical staff membership and make recommendations to the governing body on the appointment of the candidates in accordance with State law, including scope-Of-practice laws, and the medical staff bylaws, rules, and regulations. A candidate who has been recommended by the medical staff and who has been appointed by the governing body is subject to all medical staff bylaws, rules, and regulations, in addition to the requirements contained in this section. This STANDARD is not met as evidenced by: A315 A 338 A341 FORM Previous Versions Obsolete Event ID: EQSF11 Facility ID: 2335 If continuation sheet Page 22 of 37 DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE MEDICAID SERVICES PRINTED: 08/23/2016 FORM APPROVED OMB NO. 0938-0391 Based on records reviewed and interviews Hospital #1 failed to provide a consistent, separate and independent process that applied equally to all staff as it related to credentialing and privileging. Findings included: The Surveyor interviewed the Chair of the Credentialing Committee at 3:15 PM. on 8/2/16. The Chair of the Credentialing Committee said that there was overlapping of the credentialing processes between Hospital #1 and Hospital #2 and it was a symbiotic relationship. The Surveyor interviewed the Credential Representative from Hospital The Credential Representative said that Hospital #1 and #2 had a joint credentialing system in place for many years. The Credential Representative provided the Surveyor with a copy of a letter from the State Board of Registration in Medicine (BORM), dated 12/1/2001. The BORM letter indicated a uni?ed approach to credentialing would improve ef?ciency and reduce duplication. The Surveyor interviewed the Credential Representative from Hospital #1 at 10:55 AM. on 8/4/16. Credential Representative #1 said that Hospital #1 relied on Hospital #2 to provide to Hospital #1 a jointly credentialed candidate's primary source veri?cation, education and training, hospital af?liations, professional references, board certi?cations, insurance information and claims, Ongoing Professional Practice Evaluation (OPPE) and Focused Professional Practice Evaluation (FPPE) and STATEMENT OF DEFICIENCIES (x1) (x2) MULTIPLE CONSTRUCTION (x3) DATE SURVEY AND PLAN OF CORRECTION IDENTIFICATION NUMBER: COMPLETED A. BUILDING 220162 B- WING 08/04/2016 NAME OF PROVIDER OR SUPPLIER STREET ADDRESS. CITY. STATE, ZIP CODE 450 BROOKLINE AVENUE DANA-FARBER CANCER INSTITUTE BOSTON, MA 02115 (x4) .0 SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDERS PLAN OF CORRECTION (st PREHX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION TAG REGULATORY OR IDENTIFYING INFORMATION) TAG CROSS-REFERENCED To THE APPROPRIATE DATE DEFICIENCY) A 341 Continued From page 22 A 341 FORM Previous Versions Obsolete Event ID: EQSF11 Facility ID: 2335 If continuation sheet Page 23 of 37 PRINTED: 08l23l2016 DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED CENTERS FOR MEDICARE MEDICAID SERVICES NO. 0938-0391 STATEMENT OF DEFICIENCIES (X1) (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A. BUILDING COMPLETED 220162 3- 08/04/2016 NAME OF PROVIDER OR SUPPLIER STREET ADDRESS. CITY, STATE. ZIP CODE 450 BROOKLINE AVENUE DANA-FARBER CANCER INSTITUTE BOSTON, MA 02115 (x4) .0 SUMMARY STATEMENT OF DEFICIENCIES ID PLAN OF CORRECTION (st pREle (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION TAG REGULATORY OR LSC IDENTIFYING INFORMATION) TAG CROSS-REFERENCED TO THE APPROPRIATE DATE DEFICIENCY) A 341 Continued From page 23 A 341 requests for clinical privileges for the candidates seeking credentials with the Medical Staff at Hospital Credential Representative #1 said Hospital #1 would then provide primary source veri?cation of the candidate for licensure. National Data Base information, and the System for Award Management before presenting the candidate to Hospital #1 's Credential Committee for approval. Credential Representative #1 said if the candidate was not to be jointly credentialed with Hospital then Hospital #1 would compile all of the candidate's credential requirements for presentation to the Credential Committee. Hospital #1 ?s Cardio-Pulmonary Resuscitation (CPR) Manual, dated 6/2014, indicated a pediatric anesthesiologist from an adjoining Pediatric Specialty Hospital (Hospital Should perform pediatric intubations (the placement of a ?exible plastic tube into the windpipe to maintain an open aiwvay) for Hospital #1 ?s pediatric patients. The Surveyor interviewed the Manager of Quality and Safety at 4:20 PM. on 8/3/16. The Manager of Quality and Safety said that while there were a number of credentialed Anesthesiologists from Hospital #3 who regularly provided services to the pediatric patient at Hospital #1 in an emergency, the responding Anesthesiologist from Hospital #3 might not have been credentialed or hold privileges at Hospital The Surveyor interviewed the Nurse Director Of Hospital #1 ?s Outpatient Satellite Treatment Center at 9:35 AM. on 8/3/16. The Nurse Director of Hospital #1 Outpatient Satellite FORM Previous Versions Obsolete Event ID: EQSF11 Facility ID: 2335 If continuation sheet Page 24 of 37 DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE MEDICAID SERVICES PRINTED: 08/23/2016 FORM APPROVED OMB NO. 0938-0391 STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) IDENTIFICATION NUMBER: 220162 (X2) MULTIPLE CONSTRUCTION A. BUILDING B. WING (X3) DATE SURVEY COMPLETED 08I04I2016 NAME OF PROVIDER OR SUPPLIER DANA-FARBER CANCER INSTITUTE STREET ADDRESS. CITY. STATE. ZIP CODE 450 BROOKLINE AVENUE BOSTON, MA 02115 (x4) ID PREFIX TAG SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) ID PREFIX TAG PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) (X5) COMPLETION DATE A 341 A 385 Continued From page 24 Treatment Center said when an emergency response Code Team or Rapid Response) was needed by a patient receiving treatment at Hospital #1?s outpatient center, the emergency response team working at adjoining Hospital #4 provides the emergency care to Hospital #1 '5 patient. The Nurse Director of Hospital #1 's Outpatient Satellite Treatment Center said the responders from Hospital #4 included the Chief of Medicine, a Critical Care Unit Nurse, the Nurse Educator or Nursing Supervisor, Anesthesia and Respiratory Therapy. The undated Service Agreement (Code Team Services) indicated that Hospital #4 would provide emergency response Code Team or Rapid Response) to Hospital #1 's outpatient unit with staff performing services on behalf of Hospital The Surveyor interviewed the Nurse Director of Hospital #1 ?s Outpatient Satellite Treatment Center at 9:35 AM. on 8/3/16. The Nurse Director of Hospital #1 's Outpatient Satellite Treatment Center provided Hospital #4's policy for the Rapid Response Team, dated December 2012. The Nurse Director of Hospital #1's Outpatient Satellite Treatment Center said this policy was used during an emergency response at Hospital #1 's outpatient satellite. Hospital #4's policy indicated the response team included a critical care nurse, a medical house of?cer, and a respiratory therapist, all of whom worked for Hospital 482.23 NURSING SERVICES A341 A 385 FORM Previous Versions Obsolete Event ID: EQSF11 Facility ID: 2335 If continuation sheet Page 25 of 37 DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE MEDICAID SERVICES PRINTED: 08/23/2016 FORM APPROVED OMB NO. 0938-0391 STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) IDENTIFICATION NUMBER: 2201 62 (x2) MULTIPLE CONSTRUCTION A. BUILDING B. WING (X3) DATE SURVEY COMPLETED 08/04/201 6 NAME OF PROVIDER OR SUPPLIER DANA-FARBER CANCER INSTITUTE STREET ADDRESS. CITY. STATE, ZIP CODE 450 BROOKLINE AVENUE BOSTON, MA 02115 (X4) ID PREFIX TAG SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) ID PREFIX TAG PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) (X5) COMPLETION DATE A 385 supervised by a registered nurse. Continued From page 25 The hospital must have an organized nursing service that provides 24-hour nursing services. The nursing services must be furnished or This CONDITION is not met as evidenced by: Based on records reviewed and interview, Hospital #1 failed to create an independent organized nursing service department separate from Hospital #2's nursing services to ensure that nursing service needs were met for the patients of Hospital Findings included: Hospital #1 failed to provide administrative nursing oversight for Hospital #1 's thirty inpatient beds including the determination of the types and numbers of nursing personnel and staff necessary to provide nursing care to patients on these units. See A 386 Hospital #1 failed to ensure that contract nursing staff met all licensing, education and certi?cation requirements of Hospital See A 394 Hospital #1 failed to ensure that contracted nursing staff adhered to Hospital #1's policies and procedures or that Hospital #1 provided supervision and evaluation of the clinical activities of each contracted staff person. See A 398 A 385 FORM Previous Versions Obsolete Event ID: EQSF11 Facility ID: 2335 If continuation sheet Page 26 of 37 DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION PRINTED: 08/23/2016 FORM APPROVED NO. 0938-0391 (X1) IDENTIFICATION NUMBER: 220162 (X2) MULTIPLE CONSTRUCTION A. BUILDING B. WING (X3) DATE SURVEY COMPLETED 08/041201 6 NAME OF PROVIDER OR SUPPLIER DANA-FARBER CANCER INSTITUTE STREET ADDRESS. CITY. STATE, ZIP CODE 450 BROOKLINE AVENUE BOSTON, MA 02115 (X4) ID PREFIX TAG SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) ID PREFIX TAG PLAN OF CORRECTION (x5) (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DATE DEFICIENCY) COMPLETION A 385 A 386 I The Wee President ofAdult Nursing and Clinical Continued From page 26 Hospital #1 failed to establish policies to govern the use of blood products. See A409 482.23(a) ORGANIZATION OF NURSING SERVICES The hospital must have a well-organized service with a plan of administrative authority and delineation of responsibilities for patient care. The director of the nursing service must be a licensed registered nurse. He or she is responsible for the operation of the service, including determining the types and numbers of nursing personnel and staff necessary to provide nursing care for all areas of the hospital. This STANDARD is not met as evidenced by: Based on records reviewed and interview Hospital #1 failed to create an independent and separate nursing service governed by accepted policies and procedures and fully responsible for the operation of the nursing service including the scheduling of nursing personnel to provide care for patients. Findings included: Services was interviewed at 8:40 AM. on 8/1/16. The Wee President of Adult Nursing and Clinical Services said Hospital #1 had a joint contract with Hospital #2 to provide nursing care to the inpatient units. The Surveyor interviewed Unit 5A Registered Nurse (RN) #1 at 9:00 AM. on 8/1/16. RN #1 said A 385 A 386 FORM Previous Versions Obsolete Event ID: EQSF11 Facility ID: 2335 If continuation sheet Page 27 of 37 PRINTED: 08/23/2016 DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED CENTERS FOR MEDICARE MQICAID SERVICES 0le NO. 0938-0391 STATEMENT OF DEFICIENCIES (X1) (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A. BUILDING COMPLETED 220162 8- WING 08/04/2016 NAME OF PROVIDER OR SUPPLIER STREET ADDRESS. CITY. STATE. ZIP CODE 450 BROOKLINE AVENUE - CE DANA FARBE AN INSTITUTE BOSTON, MA 02115 (x4) ID SUMMARY STATEMENT OF DEFICIENCIES ID PLAN OF CORRECTION (x5) PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION TAG REGULATORY OR LSC IDENTIFYING INFORMATION) TAG CROSS-REFERENCED TO THE APPROPRIATE DATE DEFICIENCY) A 386 Continued From page 27 A 386 she and all the staff working on the unit were employed by Hospital RN #1 said Hospital #2 provided all of the services to the patients on the unit including care coordination, pharmacy. food, transport and infection control. The Surveyor interviewed Unit 58 Registered Nurse (RN) #2 at 10:40 AM. on 8/1/16. RN #2 said when a patient on the unit required a medical emergency response team i.e. the Code Team (Cardiac Arrest), the Rapid Response (a patient exhibiting signs of clinical deterioration) or a STAT Nurse (additional nursing staff). Hospital #2 provided these response teams. RN #2 said these were specially trained teams who would respond to emergencies on both Hospital #1 and #23 patient units located within the tower building. The Surveyor interviewed the Risk Manager for Hospital #2 at 10:55 AM. The Risk Manager for Hospital #2 said if a Hospital #1 patient required IV (Intravenous) therapy services or placement of a peripherally inserted central catheter (PICC), the nursing team working at Hospital #2 would be called to perform this specialized service. The Surveyor interviewed the Interim Nursing Director at 11:40 AM. on 8/2/16. The Interim Nursing Director said she was employed by Hospital #2 and provided supervision to Hospital #1's contracted nursing staff. The Interim Nursing Director said she was responsible for scheduling and evaluating the contracted nursing staff. The Surveyor interviewed the Nurse Director of the Hospital #1's Outpatient Satellite Treatment Center at 9:35 AM. on 8/3/16. The Nurse FORM Previous Versions Obsolete Event ID: EQSF11 Facility ID: 2335 If continuation sheet Page 28 Of 37 DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE 8: MEICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION PRINTED: 08/23/2016 FORM APPROVED OMB NO. 0938-0391 (X1) IDENTIFICATION NUMBER: 220162 (X2) MULTIPLE CONSTRUCTION A. BUILDING B. WING (x3) DATE SURVEY COMPLETED 08/04/2016 NAME OF PROVIDER OR SUPPLIER DANA-FARBER CANCER INSTITUTE STREET ADDRESS. CITY, STATE. ZIP CODE 450 BROOKLINE AVENUE BOSTON, MA 02115 (X4) ID PREFIX TAG SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) ID PREFIX TAG PLAN OF CORRECTION (x5) (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DATE DEFICIENCY) COMPLETION A 386 A 394 Continued From page 28 Director of the Hospital #1 's Outpatient Satellite Treatment Center said when an emergency response (ie. Code Team or Rapid Response) was needed by a patient being treated at Hospital #1's outpatient center, the emergency response team working at adjoinig Hospital #4 provided the emergency care to Hospital #1's patient. The Nurse Director of the Hospital #1 's Outpatient Satellite Treatment Center said she only provided oversight to the eight (8) contract employees working in the Outpatient Center. LICENSURE OF NURSING STAFF The nursing service must have a procedure in place to ensure that hospital nursing personnel for whom current licensure is required have a valid and current licensure. This STANDARD is not met as evidenced by: Based on records reviewed and interviews, the nursing service of Hospital #1 failed to ensure that contract nursing staff employed by Hospital #2 met all licensing, education and certi?cation requirements of Hospital Findings included: The Surveyor interviewed the Interim Nursing Director at 11:40 AM. on 8/2/16. The Interim Nursing Director said she was employed by Hospital #2 and provided staff evaluation for Hospital #1's contracted nursing staff. The Interim Nursing Director said all newly hired contracted nurses were oriented at Hospital #28 new hire orientation program. The Interim Nursing Director said unit orientation was provided by the Nurse Educators from Hospital The Interim Nursing Director said orientation to Hospital #1's nursing A 386 A 394 FORM Previous Versions Obsolete Event ID: EOSF11 Facility ID: 2335 If continuation sheet Page 29 of 37 DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE MEDICAID SERVICES PRINTED: 08/23/2016 FORM APPROVED OMB NO. 0938-0391 STATEMENT OF DEFICIENCIES (X1) (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY units was provided by the contracted nurses from Hospital The Surveyor reviewed six contract nurses personnel and education records for Hospital #1 's contracted staff at 3:00 PM. on 8/2/16. The Interim Nursing Director assisted in the review. The records indicated the annual nursing review was completed by the Interim Nursing Director and the education was an on-Iine program furnished by Hospital Contract RN #1 's orientation summary, dated 1/28/14 thru 4/11/14, indicated the orientation to Hospital #1 was provided by Hospital including orientation to Hospital #28 Clinical Practice Manual, Patient Education Material and Blood Transfusion policy. The Surveyor interviewed the Float Pool Manager, employed by Hospital at 2:30 PM. on 8/2/16. The Float Pool Manager said there were ?fty ?ve (55) nurses eligible to be STAT or Code Nurses. The Float Pool Manager provided the Float Pool-Code RN Competency Schedule, dated 2015, to the Surveyor. The Float Pool-Code RN Competency indicated Hospital #23 code policies were used to evaluate competency. The Surveyor interviewed the Nurse Director of Hospital #1 's Outpatient Satellite Treatment Center at 9:35 AM. on 8/3/16. The Nurse Director of Hospital #1 ?s Outpatient Satellite Treatment Center said when an emergency response Code Team or Rapid Response) is needed by a patient being treated at Hospital #1 ?s outpatient satellite center, Hospital #4?s AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A. BUILDING COMPLETED 220162 B- WING 0810412016 NAME OF PROVIDER 0R SUPPLIER STREET ADDRESS. CITY. STATE, ZIP CODE 450 BROOKLINE AVENUE DANA-FARBER CANCER INSTITUTE BOSTON, MA 02115 (x4) ID SUMMARY STATEMENT OF DEFICIENCIES ID PLAN OF CORRECTION (x5) PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION TAG REGULATORY OR LSC IDENTIFYING INFORMATION) TAG CROSS-REFERENCED TO THE APPROPRIATE DATE DEFICIENCY) A 394 Continued From page 29 A 394 FORM Previous Versions Obsolete Event ID: EQSF11 Facility ID: 2335 If continuation sheet Page 30 of 37 DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE MEDICAID SERVICES PRINTED: 08/23/2016 FORM APPROVED OMB NO. 0938-0391 STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) IDENTIFICATION NUMBER: 220162 (X2) MULTIPLE CONSTRUCTION A. BUILDING B. WING (X3) DATE SURVEY COMPLETED 08l04l201 6 NAME OF PROVIDER OR SUPPLIER DANA-FARBER CANCER INSTITUTE STREET ADDRESS. CITY, STATE. ZIP CODE 450 BROOKLINE AVENUE BOSTON, MA 02115 (x4) ID PREFIX TAG SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) ID PREFIX TAG PLAN OF CORRECTION (st (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DATE DEFICIENCY) COMPLETION A 394 A 398 Continued From page 30 emergency response team provided the emergency care to Hospital #1 '8 patient. The Service Agreement indicated the response team members were to be employees in good standing from Hospital SUPERVISION OF CONTRACT STAFF Non-employee licensed nurses who are working in the hospital must adhere to the policies and procedures of the hospital. The director of nursing service must provide for the adequate supervision and evaluation of the clinical activities of non-employee nursing personnel which occur within the responsibility of the nursing services. This STANDARD is not met as evidenced by: Based on records reviewed and interview, Hospital #1 failed to ensure that contracted nursing staff adhered to Hospital #1 's policies and procedures or that Hospital #1 provided supervision and evaluation of the clinical activities for each contracted staff person. Findings included: The Surveyor interviewed Unit 53 Registered Nurse (RN) #3 at 8:40 AM. on 8/2/16. RN When RN #3 was asked to access the Hospital?s nursing policies and procedures, RN #3 demonstrated the on-Iine policy manual labeled as Hospital #23 nursing policy manual. The Surveyor interviewed the Associate Chief Nurse of Oncology. Medical and Integrative Nursing at 4:30 PM. on 8/2/16. The Associate Chief Nurse of Oncology. Medical and Integrative Nursing said she was employed by both Hospital A 394 A 398 FORM Previous Versions Obsolete Event ID: EQSF11 Facility ID: 2335 If continuation sheet Page 31 of 37 DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE MEDICAID SERVIQES PRINTED: 08/23/2016 FORM APPROVED OMB NO. 0938-0391 STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDERISUPPLIERICLIA IDENTIFICATION NUMBER: 2201 62 (x2) MULTIPLE CONSTRUCTION A. BUILDING B. WING (x3) DATE SURVEY COMPLETED 08I04I2016 NAME OF PROVIDER OR SUPPLIER DANA-FARBER CANCER INSTITUTE STREETADDRESS, CITY, STATE, ZIP CODE 450 BROOKLINE AVENUE BOSTON, MA 02115 (X4) ID PREFIX TAG SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) ID PREFIX TAG PLAN OF CORRECTION (x5) (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DATE DEFICIENCY) COMPLETION A 398 Continued From page 31 #1 and Hospital The Associate Chief Nurse of Oncology, Medical and Integrative Nursing said she managed ten (10) Nursing Directors who in turn supervised the Oncology Service including the three (3) units licensed to Hospital The Associate Chief Nurse of Oncology, Medical and Integrative Nursing said the ten Nursing Directors were employed by Hospital The Associate Chief Nurse of Oncology, Medical and Integrative Nursing said the Nurse Educators were employed by Hospital #2 and provided education, training and competency evaluation for Hospital #1's contracted nurses. The Associate Chief Nurse of Oncology, Medical and Integrative Nursing said the policies used on the inpatient units were solely from Hospital #2 and Oncology speci?c policies were written dually by Hospital #1 and The Surveyor interviewed the Interim Nursing Director at 11 :40 AM. on 8/2/16. The Interim Nursing Director said she was employed by Hospital #2 and provided supervision to Hospital #1 's contracted nursing staff including the performance evaluations for the contracted nursing staff. The Surveyor interviewed the Nurse Director of Hospital #1 ?s Outpatient Satellite Treatment Center at 9:35 AM. on 8/3/16. The Nurse Director of Hospital #1 's Outpatient Satellite Treatment Center said when an emergency response Code Team or Rapid Response) is needed by a patient being treated at Hospital #1 ?s outpatient center, adjoining Hospital #4?s emergency response team, including nurses, provided the emergency care to Hospital #1's patient. The Nurse Director of Hospital #1's A 398 FORM Previous Versions Obsolete Event ID: EQSF11 Facility ID: 2335 If continuation sheet Page 32 of 37 DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE MQICAID SERVICES PRINTED: 08/23/2016 FORM APPROVED NO. 0938-0391 Outpatient Satellite Treatment Center said the responders from Hospital #4 included the Chief of Medicine, Critical Care Unit Nurse, the Nurse Educator or Nursing Supervisor, Anesthesia and Respiratory Therapy. The undated Service Agreement between Hospital #1 and Hospital #4 related to the Code Team Response indicated the Emergency Response Team responded to Hospital #1 's emergencies. The Service Agreement indicated personnel responding to the emergency were to follow Hospital #4's guidelines and response policy. The Agreement indicated the staff were performing services on behalf of Hospital The Nurse Director of the Hospital #1's Outpatient Satellite Treatment Center said she only provided oversight to the eight (8) contract employees working in the Outpatient Center. The Surveyor reviewed the Service Agreement between Hospital #3 (a pediatric specialty hospital) and Hospital dated 6/30/2009. The Agreement indicated that Hospital #3 would provide an emergency response team, including three senior nurses, in the event of a pediatric code at Hospital The Agreement indicated that the nurses responding to the pediatric code would leave the pediatric specialty hospital and be met at a Hospital #1 entrance by Security Staff from Hospital #1 who would direct the pediatric code responders to the location of the emergency. The Agreement indicated that nurses would be duly licensed in the State, however, theses nurses were not on staff or contracted with STATEMENT OF DEFICIENCIES (X1) (x2) MULTIPLE CONSTRUCTION (x3) DATE SURVEY AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A BUILDING COMPLETED 220162 08/04/2016 NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE 450 BROOKLINE AVENUE DANA-FARBER CANCER INSTITUTE BOSTON, MA 02115 (x4) .0 SUMMARY STATEMENT OF DEFICIENCIES In PLAN OF CORRECTION (x5) (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION TAG REGULATORY OR LSC IDENTIFYING INFORMATION) TAG CROSS-REFERENCED TO THE APPROPRIATE DATE DEFICIENCY) A 398 Continued From page 32 A 398 FORM Previous Versions Obsolete Event ID: EQSF11 Facility ID: 2335 If continuation sheet Page 33 of 37 DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION PRINTED: 08/23/2016 FORM APPROVED OMB NO. 0938-0391 (x1) IDENTIFICATION NUMBER: 2201 62 (X2) MULTIPLE CONSTRUCTION A. BUILDING B. WING (x3) DATE SURVEY COMPLETED 08l04l2016 NAME OF PROVIDER OR SUPPLIER DANA-FARBER CANCER INSTITUTE STREET ADDRESS. CITY. STATE. ZIP CODE 450 BROOKLINE AVENUE BOSTON, MA 02115 (X4) ID PREFIX TAG SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) ID PREFIX TAG PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DATE DEFICIENCY) COMPLETION A 398 A 409 A431 Continued From page 33 Hospital BLOOD TRANSFUSIONS AND IV MEDICATIONS Blood transfusions and intravenous medications must be administered in accordance with State law and approved medical staff policies and procedures. If blood transfusions and intravenous medications are administered by personnel other than doctors of medicine or osteopathy, the personnel must have special training for this duty. This STANDARD is not met as evidenced by: Based on records reviewed and interviews, Hospital #1 failed to establish separate and independent policies to govern the use of blood products. Findings included: The Survey team requested the Hospital #1 's policy on Blood Transfusion at the opening conference. The policy. titled Blood Products Administration, indicated the policy was from Hospital #2 with Hospital #25 approval dates and there was no evidence that Hospital #1 had reviewed or approved this policy for use in the inpatient units. 482.24 MEDICAL RECORD SERVICES The hospital must have a medical record service that has administrative responsibility for medical records. A medical record must be maintained for every individual evaluated or treated in the hospital. This CONDITION is not met as evidenced by: A 398 A 409 A431 FORM Previous Versions Obsolete Event ID: EQSF11 Facility ID: 2335 If continuation sheet Page 34 of 37 PRINTED: 08/23/2016 DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED CENTERS FOR MEDICARE MEDICAID SERVICES OMB NO. 0938-0391 STATEMENT OF DEFICIENCIES (x1) (x2) MULTIPLE CONSTRUCTION (x3) DATE SURVEY AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A. BUILDING COMPLETED 27-0162 3- 08I04I2016 NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE. ZIP CODE 450 BROOKLINE AVENUE DANA-FARBER CANCER INSTITUTE BOSTON, MA 02115 (x4) .0 SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDERS PLAN OF CORRECTION (st PREHX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE TAG REGULATORY OR IDENTIFYING INFORMATION) TAG CROSS-REFERENCED To THE APPROPRIATE DATE DEFICIENCY) A431 Continued From page 34 A431 Based on records reviewed and interviews, for 14 of 14 patients sampled patients, Hospital #1 failed to have an independent medical record services department that was exclusive to the facility and independent from Hospital #28 medical record service. Findings included: Fourteen of 14 medical records reviewed indicated that the Hospital created a continuous electronic medical record across two identi?ed hospitals, Hospital #1 and Hospital Please refer to A 450 A432 482.24(a) ORGANIZATION AND STAFFING A432 The organization of the medical record service must be appropriate to the scope and complexity of the services performed. The hospital must employ adequate personnel to ensure prompt completion, ?ling, and retrieval of records. This STANDARD is not met as evidenced by: Based on records reviewed and interviews Hospital #1 failed to maintain a medical record service for the thirty (30) inpatient beds licensed to Hospital #1 that was exclusive to Hospital Findings included: The Surveyor interviewed the Director Of Health Information Services at 2:00 PM. on 8/2/16. The Director of Health Information Services said the medical records for Hospital #1's patients was a joint venture with Hospital The Director Of Health Information Services said Hospital #2 will maintain Hospital #1's inpatient medical records. FORM Previous Versions Obsolete Event ID: EOSF11 Facility ID: 2335 If continuation sheet Page 35 of 37 DEPARTMENT OF HEALTH AND HUMAN SERVICES . CENTERS FOR MEDICARE 8: MEDICAID SERVICES PRINTED: 08/23/2016 FORM APPROVED OMB NO. 0938-0391 All patient medical record entries must be legible, complete, dated, timed, and authenticated in written or electronic form by the person responsible for providing or evaluating the service provided, consistent with hospital policies and procedures. This STANDARD is not met as evidenced by: Based on observations, records reviewed and interviews, Hospital #1 failed to ensure a completed medical record for 4 patients (Patient #7 and in a sample of 14 patient records. Findings include: During a tour of BC on 8/1/16 at approximately 2:00 PM, the Surveyor observed that electronically generated medication orders were titled Protocol Regimen Orders and placed in the inside jacket binder of Patient #7 and #8's medical record. The orders titled Protocol Regimen Orders were not identi?ed with patient names for proper identi?cation and may have lead to medical errors. Patient #7?s consent for placement of a tunneled catheter, dated 7/20/16 and to be performed in STATEMENT OF DEFICIENCIES (x1) (x2) MULTIPLE CONSTRUCTION (x3) DATE SURVEY AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A BUILDING COMPLETED 220162 08I04l2016 NAME OF PROVIDER OR SUPPLIER STREET ADDRESS. CITY, STATE, ZIP CODE 450 BROOKLINE AVENUE DANA-FARBER CANCER INSTITUTE BOSTON, MA 02115 (x4) .0 SUMMARY STATEMENT OF DEFICIENCIES ID PLAN OF CORRECTION (st PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION TAG REGULATORY OR LSC IDENTIFYING INFORMATION) TAG CROSS-REFERENCED To THE APPROPRIATE DATE DEFICIENCY) A432 Continued From page 35 A432 The Surveyor interviewed the Nurse Educator for the Oncology service at 10:50 AM. on 8/1/16. The Nurse Educator said if Hospital #1 received a patient request for their medical record, the patient would be sent to Hospital #23 medical record services. A450 MEDICAL RECORD SERVICES A450 FORM Previous Versions Obsolete Event ID: EQSF11 Facility ID: 2335 If continuation Sheet Page 36 of 37 PRINTED: 08/23/2016 DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED CENTERS FOR MEQICARE MEDICAID SERVICES OMB NO. 0938-0391 STATEMENT OF DEFICIENCIES (x1) (x2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY AND PLAN OF CORRECTION IDENTIFICATION NUMBER: BUILDWG COMPLETED 220152 08I04I2016 NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY. STATE. ZIP CODE 450 BROOKLINE AVENUE DANA-FARBER CANCER INSTITUTE BOSTON, MA 02115 (x4, .0 SUMMARY STATEMENT OF DEFICIENCIES Io PLAN OF CORRECTION (st PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION TAG REGULATORY OR LSC IDENTIFYING INFORMATION) TAG CROSS-REFERENCED TO THE APPROPRIATE DATE DEFICIENCY) A450 Continued From page 36 A450 the interventional radiology department, was not timed. Patient consent for placement Of a tunneled catheter, dated 7/8/16 and to be performed in the interventional radiology department, was not timed. Patient #8's blood transfusion record, dated 8/1/16, did not contain the discipline of the staff member who veri?ed the patient?s informed consent and veri?ed the unit Of blood to the patient's identi?cation. Patient #3's blood transfusion record, dated 8/1/16, did not contain the discipline of the staff member who veri?ed the patient's informed consent and veri?ed the unit of blood to the patient's identi?cation. FORM Previous Versions Obsolete Event EQSF11 Facility ID: 2335 If continuation sheet Page 37 of 37