Table of Contents 42 CFR 482.12 Governing Body .............................................................................................. 2 A043 Governing Body ..................................................................................................... 3 Additional Information about inpatient hospital policies and procedures ......................15 A083 Contracted Services .............................................................................................18 42 CFR 482.13 Patient Rights .................................................................................................22 A115 Patient Rights .......................................................................................................23 A116 Patient Rights: Notice of Rights ..........................................................................28 A118 Patient Rights: Grievances ...................................................................................33 42 CFR 482.21 Quality Assessment and Performance Improvement ..................................39 A263 QAPI .......................................................................................................................40 A273 Data Collection and Analysis ...............................................................................44 A286 Patient Safety........................................................................................................51 A308 QAPI Governing Body, Standard Tag ..................................................................55 A309 QAPI Executive Responsibilities ..........................................................................58 A315 Providing Adequate Resources ...........................................................................62 42 CFR 482.22 Medical Staff ...................................................................................................65 A338 Medical Staff ..........................................................................................................66 A341 Medical Staff Credentialing..................................................................................70 42 CFR 482.23 Nursing Services ............................................................................................78 A385 Nursing Services ...................................................................................................79 A386 Organization of Nursing Services .............................................................................82 A394 Licensure of Nursing Staff ........................................................................................90 A398 Supervision of Contract Staff ....................................................................................96 A409 Blood Transfusions and IV Medications ................................................................102 42 CFR 482.24 Medical Record Services .............................................................................105 A431 Medical Record Services ...................................................................................106 A432 Organization and Staffing ..................................................................................114 A450 Medical Record Services ...................................................................................117 Attachments ..........................................................................................................................123 1 42 CFR 482.12 Governing Body Tag A043 Governing Body Completion Date – March 31, 2017 1. Corrective Action Dana-Farber Cancer Institute (DFCI or the Institute) is governed by a Board of Trustees (Board of Trustees or Board). The Governing Trustee members of the Board of Trustees are responsible for the conduct of the hospital. The Board of Trustees is committed to ensuring that DFCI operates as a hospital that is separate and independent of any other hospital, in accordance with the Conditions of Participation (COPs). DFCI has taken steps to clarify and strengthen the Board’s independent oversight role generally, and specifically with respect to this Plan of Correction (POC). As the body ultimately responsible for the conduct of the hospital, the Board of Trustees ensures that all commitments set forth in this POC are met by the relevant date(s) identified herein. As further detailed below, the Board has received updates on POC related activities at each of its meetings since the complaint survey concluded on August 4, 2016 (including meetings on October 24, 2016 and January 30, 2017), and will continue to receive updates through the end of the monitoring period. At its meeting on October 24, 2016, the Board participated in a detailed education session regarding the COPs, the survey findings, key aspects of DFCI’s proposed POC, and the critical importance of DFCI maintaining a separate and distinct hospital. The Board is committed to providing independent oversight over all of DFCI’s hospital functions in a meaningful way and on an ongoing manner. Certain oversight responsibilities of the Board are delegated to committees of the Board of Trustees, providing the Board with appropriate oversight of hospital operations. The three Board committees responsible for overseeing POC progress for the specific COP subject areas addressed herein, include the Executive Committee of the Board, the Board Committee on Quality Improvement and Risk Management (QI/RM Committee), and the Board Audit and Compliance Committee, as depicted in the below graphic. See Attachment: A043-01 POC Governing Body Reporting Figure. As described in detail throughout this POC (in particular see Tags A263-A315), the QI/RM Committee has responsibility for overseeing DFCI’s quality assessment and performance improvement (QAPI) program, which expressly includes as a key priority, compliance with the POC. The oversight role of these Board committees includes services provided directly by DFCI and those services provided under contract. 4 QAPI The Board of Trustees is committed to overseeing and ensuring the performance of a robust and effective, hospital-wide quality assessment and performance improvement program that measures, analyzes and tracks process of care indicators and outcomes for all DFCI ambulatory and the inpatient hospital on an ongoing basis, whether provided directly by DFCI employees or furnished under contract. This QAPI structure, which is independent of any other hospital, is overseen by the QI/RM Committee. To ensure compliance with the COPs, DFCI reorganized its QAPI structure as discussed in this POC at Tags A263-A315 and as detailed in the QAPI Plan. See Attachment A263-01: QAPI Plan. DFCI clarified the role of the QI/RM Committee to specifically include oversight of all corrective measures identified in this POC. To achieve this objective, the POC is included in the QAPI Plan as a key performance improvement priority for DFCI. The most recent version of the QAPI Plan was approved by the QI/RM Committee on December 9, 2016. See Attachment A263-01: QAPI Plan. Details regarding the QAPI Plan are described in Tags A263 and A273. For each action in the POC, DFCI has identified the following reporting structure: (i) reporting to the Executive POC Committee to ensure coordinated leadership oversight and accountability for sustained compliance with all POC commitments, and (ii) reporting to committees of the Board of Trustees to ensure governing body oversight. Overall progress on the POC is monitored quarterly by the Quality Improvement Committee (a management committee described in detail in Tags A263-A315) and by the QI/RM Committee, in their respective roles in overseeing QAPI function. The QI/RM Committee reports quarterly to the Board of Trustees and such reports include information about POC progress. To-date, reports on POC progress have been 5 presented to the QI Committee on February 2, 2017 and February 28, 2017, and to the QI/RM Committee on December 9, 2016 and February 3, 2017. In addition, an update was provided to the Board of Trustees on January 30, 2017. In response to DPH’s question in the October 21, 2016 letter asking how DFCI’s governing body will oversee QAPI related to DFCI patients, the QAPI program and QAPI Plan, as noted above, is overseen by the QI/RM Committee. The QI/RM Committee reviews quality and patient safety quarterly, at minimum. The QI/RM Committee also holds the DFCI leadership accountable for the completion of prioritized performance improvement projects. These projects are presented to QI/RM quarterly, at minimum, or more frequently if needed. The QI/RM Committee’s oversight includes quality and performance metrics related to services purchased under arrangement for the inpatient hospital (contracted services). These metrics are approved by the QI/RM Committee upon creation or modification and are integrated into the QAPI process. Performance and quality metrics for each contracted service will be reviewed by the QI/RM Committee at least annually to ensure appropriate oversight. The QI/RM Committee includes QAPI oversight in its quarterly reports to the Board of Trustees. Independent Medical Staff Credentialing DFCI’s organized medical staff is committed to ensuring the quality of medical care provided to its patients and to operating under bylaws approved by the Board of Trustees. Furthermore, DFCI’s medical staff and the Board of Trustees are committed to ensuring that the DFCI Medical Staff Bylaws (Bylaws) apply equally to all staff as relates to credentialing (which includes appointments to the medical staff and privileging). To ensure continued compliance with the COPs, DFCI has revised the Bylaws to reflect the implementation of an independent credentialing process applicable to all members of the medical staff, as described in Tags A338 and A341. As of October 24, 2016, DFCI ceased utilizing the joint credentialing process described in the previous version of the Bylaws and the related medical staff policy titled, “DanaFarber Cancer Institute (DFCI) and Brigham and Women’s Hospital (BWH) Joint Credentialing Process,” to align with the amended Bylaws, and to implement the independent credentialing process described in Tags A338 and A341. See Attachment A338-01: Medical Staff Bylaws. As described in Tags A338 and A341, the last cohort of joint credentialed physicians had their credentials approved by the Board on October 24, 2016, and from this date forward, all medical staff members applying for appointment or reappointment to the DFCI medical staff and for clinical privileges are being, and will continue to be, evaluated through a consistent, separate and independent credentialing process. All application materials are being reviewed by DFCI with no reliance on, overlap with or joint processes shared with any other hospital. DFCI is performing all primary source verification and is processing all requests for clinical privileges for candidates seeking DFCI credentials. In order to meet the commitments in the above paragraph, DFCI has taken, and continues to take, significant steps to fully credential the approximately 1,200 physicians who were previously credentialed by DFCI pursuant to a Massachusetts Board of Registration in Medicine-approved joint credentialing process. In order to process and review a total of approximately 1,200 credentialing applications, the DFCI Medical Staff Credentials Committee, Medical Staff Executive Committee and Board of 6 Trustees (or authorized Board committee) did and/or will schedule additional meetings or extend existing meetings from December 2016– March 2017 to address the volume of applications. To meet the March 31, 2017 timeline for review of all previously joint credentialed applicants, DFCI has completed committee and Board reviews of 860 applications as of March 2, 2017, and anticipates completion of all outstanding applications in March 2017. Additional detail in table format is provided at Tag A341. If, by March 31, 2017, a physician has not been credentialed via the independent DFCI credentialing process, he or she will not be allowed to consult or provide any service to a patient in the DFCI inpatient hospital. Independent Oversight of Services Provided Under Contract As described in the response to Tag A083, DFCI’s Board of Trustees is responsible for providing oversight to ensure that all services purchased under arrangement for the inpatient hospital (contracted services) are provided appropriately and in alignment with quality and performance standards developed by DFCI. This oversight is provided through integration of contracted services into the QAPI Plan and process, which involves enhanced reporting relationships between the DFCI staff providing front-line and executive-level monitoring and oversight and the QI/RM Committee. Each DFCI contracted services agreement, or service level arrangement attached thereto, includes quality indicators that contribute to performance monitoring by DFCI. The detailed process for overseeing all contracted services agreements was approved by the QI/RM Committee on December 9, 2016. DFCI’s contract monitoring structure integrally involves the QI/RM Committee in the oversight of contracted services agreements. Each contract has a designated DFCI business or clinical owner who is a DFCI employee with responsibility for overseeing the day-to-day operations of the specific contracted-for service, including the periodic collection of quality indicators (each a “DFCI Service Owner”). Beginning November 8, 2016, each DFCI Service Owner was aligned with one of three DFCI executive sponsors who is responsible for contracted services agreements: the DFCI Chief Nursing Officer, the DFCI Senior Vice President of Institute Operations or the DFCI Chief Medical Officer (each, a “DFCI Executive Sponsor”). To facilitate DFCI’s ongoing monitoring and oversight of contracted services, DFCI Executive Sponsors will provide quarterly reports on contracted services to the QI Committee commencing with the period ending March 31, 2017. These reports will also include performance and quality indicator detail collected from the DFCI Service Owners and analysis of each service provider’s compliance with such quality indicators. Based on the DFCI Executive Sponsors’ reports, the QI Committee will report at least annually to the QI/RM Committee on the current status of all contracted services, which report will include information on whether each services provider is meeting performance and quality indicators and performance improvement activities. The QI/RM Committee will oversee the DFCI Executive Sponsors’ and the QI Committee’s implementation of corrective actions or improvement activities pertaining to contracted services. As needed, the QI/RM Committee will receive additional follow-up reports from the DFCI Executive Sponsors and/or the QI Committee identifying the outcomes of such corrective actions or improvement activities. In addition, a Co-Chair of the QI/RM Committee will provide an annual report to the Board of Trustees on the QI/RM Committee’s oversight of contracted services. 7 Independent Oversight of Policies and Procedures As of November 21, 2016, DFCI prepared and published a separate and independent policies and procedures (in a new Inpatient Hospital Policy Manual (Manual)) governing care provided to DFCI’s inpatients. The Manual was prepared by relevant executive sponsors and content experts and was reviewed/approved by applicable management-level committees (e.g., Medical Staff Executive Committee). On December 9, 2016, the QI/RM Committee approved the Institute’s process to establish and educate staff on Manual governing care provided to DFCI inpatients. Extensive training and education efforts were deployed to ensure that all applicable clinical and administrative staff are familiar with how to access, and the content of, such Manual. The QI/RM Committee will ensure that this deficiency is fully remedied by March 31, 2017 in the manner described herein. Independently Ensuring Patient Rights are Met DFCI and its Board of Trustees are committed to continuing to protect and promote each patient’s rights, as described in detail in Tags A115-A118. To ensure compliance with the Patient Rights COP and the commitments set forth in Tags A115-A118, at its meeting on December 9, 2016, the QI/RM Committee received a report from the Institute’s Chief Quality Officer (CQO) and Chief Financial Officer (CFO) informing the Committee that the Institute had: (1) adopted a new policy which sets forth the policy and procedure for DFCI’s provision of its independent patient rights and responsibilities to DFCI inpatients (and outpatients) (see Attachment A115-01: Patient Rights and Responsibilities Notice Policy, 9.14); and (2) revised an existing policy which describes how DFCI promptly investigates and handles all patient (inpatient and outpatient) complaints, and grievances (see Attachment A115-02: Patient Complaint/Grievance/Request Management Policy, 9.04). The CQO and CFO also described to the QI/RM Committee at the December meeting the Institute’s new process for providing DFCI inpatients with the DFCI Patient Rights and Responsibilities Notice (Notice). They reported that the Notice was updated to reflect the quality improvement organization (QIO) that patients can contact with a complaint regarding DFCI’s quality of care or disagreement with a coverage decision. The CQO and CFO reported that the Notice has been conspicuously posted in the Institute’s inpatient hospital. In addition, the CQO and CFO described to the QI/RM Committee at the December meeting how DFCI ensures an independent process for prompt resolution of grievances. In summary, and as described in greater detail at Tag A118, inpatient complaints/grievances are directed to DFCI’s Patient and Family Relations (P/FR) office. Upon receipt of such complaints/grievances the report is logged and the P/FR staff promptly begin to investigate the report. DFCI P/FR speak with the inpatient or complainant to learn more about the complaint/grievance. The staff may also need to speak with the inpatient’s care team to learn more. DFCI works to promptly remedy the complaint/grievance. DFCI’s P/FR staff communicate in writing (and often, verbally) with the inpatient or complainant to communicate how (or if) the matter was remedied. Depending on the nature of the matter, DFCI’s P/FR staff may communicate with the inpatient’s care team to describe how (or if) the matter was remedied. The matter is then closed in the DFCI P/FR log. Generally, inpatient complaints/grievances are resolved within seven (7) days of 8 receipt of the report. If this is not possible, they are resolved no later than thirty (30) days from receipt, unless there are extenuating circumstances. Independent Medical Record Service DFCI and the Board Audit and Compliance Committee are committed to ensuring that the Institute has a separate and independent medical record service that has administrative responsibility for DFCI’s inpatients. To ensure compliance with the COPs, DFCI is undertaking two comprehensive corrective actions as described in detail in Tags A431-A450. First, as of October 6, 2016, DFCI reorganized its existing independent medical records services department to include records for DFCI hospital inpatients. This reorganization includes DFCI’s storage of medical records, release of patient medical record information (ROI), and chart analysis/completion. Second, as of March 1, 2017 DFCI has restructured its existing electronic medical record (EMR) platform (i.e., the Epic EMR) to provide a discernible, independent medical record for every individual evaluated or treated in the hospital, including DFCI inpatients. This restructuring includes ensuring that DFCI appears as a separate hospital entity from other hospitals on the Epic platform when locating a DFCI-admitted hospital inpatient, adding the DFCI medical record number to the EMR patient chart header and patient wristbands, displaying inpatients as DFCI admissions and ensuring inpatient admissions are separate and distinct encounters in the Epic platform from Hospital #2 admissions/encounters. 2. Communication/Education The Board of Trustees has been informed of the survey process, the issues raised in the Form 2567, the subsequent October 21, 2016 letter from DPH, and other DPH/CMS communications; and has been informed of DFCI’s responses to such writings and communications. In addition to extensive discussions at Board committee meetings, the Board has been periodically updated by DFCI leadership on the POC preparation and POC activities undertaken to-date. On September 29, 2016, the Board Executive Committee met and reviewed the POC and the status of the corrective actions identified in the POC, and took action on certain of the corrective actions described in Tags A273 and A286. Notably, at this meeting, the Executive Committee was informed of the proposed Bylaws changes. At its October 24, 2016 meeting, the Board was further updated on the survey process, reviewed the POC and the status of the corrective actions identified in the POC, and took action on certain of those corrective actions, including approving the updated Bylaws. At this October 24, 2016 meeting, the General Counsel/Chief Governance Officer along with special counsel provided in-person refresher education to the Board regarding its responsibilities under the COPs generally, and specifically, its responsibilities relative to the COPs that were identified in the Form 2567 and ensuring the Institute’s independence. At its January 30, 2017 meeting, the Board received an update from leadership regarding actions taken to date, as described below, in implementing the various commitments set forth in this POC. At each subsequent meeting of the Board through the period during which DFCI is implementing this POC, the Board will receive regular reports from Board committees and DFCI leadership regarding progress made toward meeting the stated commitments in this POC, and the Board will provide input and take appropriate action to effectuate this POC. 9 QAPI As described in Tags A263-A315, the revised DFCI Quality Dashboard and the QAPI Plan were reviewed in detail and discussed with appropriate institutional leaders and with QI/RM Committee members prior to approval by the QI/RM Committee on October 21, 2016. See Attachment A263-03: Populated DFCI Quality Dashboard. Additionally, in October 2016, DFCI’s Quality and Patient Safety Department oriented DFCI staff managers representing all disciplines and departments within DFCI regarding the revised QAPI Plan through email communication; written acknowledgement of receipt and understanding were required and obtained from all recipients. A revised version of the QAPI Plan was presented to, and approved by, the QI/RM Committee on December 9, 2016. See Attachment A263-01: QAPI Plan. Independent Medical Staff Credentialing As described in Tags A338 and A341, the Executive Committee of the Board of Trustees was informed by the General Counsel/Chief Governance Officer of the revised credentialing practices and proposed Bylaws changes at its meeting on September 29, 2016, and the Board of Trustees approved these changes at its meeting on October 24, 2016. All DFCI medical staff members were informed by DFCI’s Chief Medical Officer of the revised credentialing practices and changes to the Bylaws by email on September 29, 2016. All DFCI Department Chairs were notified by DFCI’s Chief Medical Officer again by separate email on September 30, 2016. Further, the changes to the Bylaws and associated credentialing processes were presented by the President of the Medical Staff at the DFCI annual medical staff meeting on October 19, 2016; which was followed by a vote of approval by the voting medical staff members. The Chair of the Medical Staff Credentials Committee informed the Credentials Committee of the revised credentialing practices and anticipated Bylaws changes on October 11, 2016, and again informed the Credentials Committee of the approved changes on November 8, 2016. As early as August 9, 2016, DFCI’s OMAPC staff were deeply involved in discussions regarding updating DFCI’s credentialing process, and in executing the resulting expanded credentialing activities. However, to ensure that the OMAPC staff were formally aware of the revisions to the Bylaws, the changes in credentialing practices, and to answer any remaining questions, on November 10, 2016, DFCI’s Chief of Staff met with all members of DFCI’s OMAPC staff for this purpose. Attendance was documented at all in-person meetings where the Bylaws changes were presented or changes in credentialing practices were discussed. Independent Oversight of Services Provided Under Contract As described in Tag A083, on October 24, 2016, the General Counsel/Chief Governance Officer and special counsel provided in-person refresher education to the Board of Trustees regarding its critical role in and responsibility for independently evaluating and overseeing the quality, safety, and performance of services purchased under arrangement for the inpatient hospital (contracted services). In November 2016, DFCI Executive Sponsors (as defined in Tag A083) provided education to all DFCI Service Owners (as defined in Tag A083) regarding their responsibilities in monitoring compliance with contracted services requirements, evaluating quality and performance indicators and reports for the contracted services, monitoring performance improvement 10 programs and corrective action plans for deficient contracted services and escalating any performance concerns to the applicable DFCI Executive Sponsor and the QI Committee. These communication and education efforts focused on reviewing processes to ensure compliance with the commitments set forth in this Tag and Tag A083. Communication and education was also provided at a general management meeting on December 15, 2016, with follow-up through email communications (with receipt confirmed) for personnel unable to attend this meeting. Independent Oversight of Policies and Procedures As described in greater detail below, training and education on the Manual was 99% complete as of February 28, 2017 and will be completed by March 31, 2017. Independently Ensuring Patient Rights are Met As described in Tags A115-A118, the CQO and CFO reported to the QI/RM Committee on October 21, 2016 that all applicable staff were appropriately trained on the Institute’s obligations regarding inpatient rights. Specifically, staff responsible for managing inpatient complaints/grievances were trained and educated on September 29, 2016 on how to oversee, address, manage and respond to inpatient complaints and grievances. Staff responsible for providing inpatients with and informing inpatients about the Patient Rights Notice were trained on September 28, 29 and 30, 2016. The training and education reviewed how to communicate with patients regarding their rights described in the Notice, how to supply patients (or their representative) with the Notice, how patients can contact DFCI’s P/FR office for assistance, how to document the provision of the Notice in the Institute’s electronic medical record, the provision of the Notice, and the physical locations of the newly posted Notice. Finally, the health care providers, support and administrative staff providing care in the inpatient hospital were trained and educated on September 30, 2016. The training and education reviewed the two patient rights policies described above (Policies 9.04 and 9.14), including how DFCI P/FR’s office oversees and manages DFCI inpatient complaints and grievances, how to contact DFCI’s P/FR’s office, the physical locations of the newly posted Notice, and how to assist the staff who are providing inpatients with, and informing inpatients of, the Notice. On a going forward basis, new staff will also be educated on these policies, as appropriate. This departmental education will be provided based on staff roles and responsibilities. Independent Medical Record Service As described in Tags A431-A450, at its December 15, 2016 meeting, the Board Audit and Compliance Committee received a report from the Institute’s Medical Record Services Executive Sponsor informing the Committee that training and education of applicable staff was completed by October 6, 2016. Specifically, DFCI’s health information services (HIS) staff (the DFCI department responsible for medical record services), as well as the vendor that is assisting DFCI in responding to ROI requests, received necessary training regarding DFCI’s responsibility over medical record services for DFCI’s inpatients. Training and education for DFCI staff regarding implementation of the independent medical record for inpatients was delivered in phases in conjunction with the phased implementation of 11 the independent medical record. Training of applicable staff on the first phase of the independent medical record was completed on January 3, 2017. Training of applicable staff on the second and final phase of the independent medical record will be completed on March 31, 2017. 3. Monitoring of Compliance QAPI As noted above, and as reflected in Tags A263-A309, the POC is included in the QAPI Plan as a key performance improvement priority for DFCI. For each action in the POC, DFCI has identified the following reporting structure: (i) reporting to the Executive POC Committee to ensure coordinated leadership oversight and accountability for sustained compliance with all POC commitments, and (ii) reporting to committees of the Board of Trustees to ensure governing body oversight. Overall progress on the POC is monitored quarterly by the Quality Improvement Committee and by the QI/RM Committee in their respective roles in overseeing QAPI function. The QI/RM Committee reports quarterly to the Board of Trustees and includes information about its oversight of the QAPI program, and specifically, POC progress. Independent Medical Staff Credentialing Starting in October 2016, and as described in Tag A341, DFCI’s OMAPC has been preparing monthly reports to document DFCI’s progress toward meeting the credentialing commitments set forth in this POC. The monthly reports include: the number of applications distributed to consulting physicians for completion, the number of applications completed and submitted to DFCI for evaluation, the number of requests for termination from the DFCI medical staff, the number of applications processed and ready for review by the Medical Staff Credentials Committee, Medical Staff Executive Committee and Board of Trustees (or authorized Board committee), and the number of applications successfully reviewed and approved or rejected by the aforementioned committees. See the most recent monthly report at Attachment A341-01: Credentialing and Privileging Monthly Report. Starting on December 15, 2016, this monthly report, and earlier versions, has been and will continue to be submitted to DFCI’s Executive POC Committee, Medical Staff Executive Committee, and Board of Trustees Executive Committee for purposes of monitoring compliance with this POC. Additionally, as requested in the October 21, 2016 letter from DPH, these reports have also been submitted on a monthly basis to DPH for review (including submissions on December 30, 2016, January 31, 2017 and February 28, 2017), with the final report scheduled for submission at the end of March 2017. Starting on March 31, 2017 (the date the credentialing corrective actions are expected to be complete), DFCI’s OMAPC will continue to monitor, on a quarterly basis, DFCI’s credentialing process to ensure that DFCI medical staff applicants are being credentialed in a manner consistent with the amended Bylaws. Specifically, DFCI’s OMAPC will select a random sample of ten (10) DFCI credentialed physicians whose applications were reviewed during the prior three (3) month period to verify that DFCI is following the credentialing process described in the amended Bylaws. This POC-specific quarterly monitoring will continue for the longer of one (1) year or until “Substantial Compliance” is achieved for four (4) consecutive quarters. “Substantial Compliance,” as defined throughout this POC, means a collective 90% compliance for those indicators monitored in any given Tag. 12 Independent Oversight of Services Provided Under Contract As described in Tag A083, in coordination with DFCI’s Quality and Patient Safety Department, the Director of Hospital Administration is ensuring that the DFCI Service Owners are collecting, evaluating and appropriately reporting to the DFCI Executive Sponsor and ultimately to the QI/RM Committee the data to monitor ongoing performance of services purchased under arrangement for the inpatient hospital (contracted services). In addition to QI/RM’s ongoing oversight of contracted services, DFCI’s Chief Operating Officer or her designee will monitor the ongoing assessment of all contracted services and associated reporting to DFCI Executive Sponsors to ensure continued compliance with this aspect of the POC. This POC-specific monitoring will be conducted on a quarterly basis for the longer of one (1) year or until Substantial Compliance is achieved for four (4) consecutive quarters. Independent Oversight of Policies and Procedures Beginning March 1, 2017 and monthly thereafter, DFCI’s clinical and quality staff will interview a sample of fifteen (15) inpatient clinical staff (including nurses) and fifteen (15) inpatient administrative staff to evaluate such staff’s: (1) ability to locate the Institute’s inpatient hospital policies, and (2) substantive knowledge of the Institute’s inpatient hospital policies. This POCspecific monitoring will continue for the longer of one (1) year or until Substantial Compliance is achieved for four (4) consecutive quarters. Results of the monitoring are reported to the Executive POC Committee on a quarterly basis at minimum and to the QI/RM Committee at each meeting during the monitoring period. The reports include a description of any noncompliance and how such activities were promptly remedied, if applicable. Any identified instances of noncompliance are immediately reported to the DFCI CMO and CNO, who ensure there is prompt remedial action. Independently Ensuring Patient Rights are Met As described in Tags A115-A118, beginning at its December 9, 2016 meeting, the QI/RM Committee began receiving quarterly auditing and monitoring activity reports regarding patient rights and corresponding corrective actions. The auditing and monitoring activity reports include: (a) confirmation that the Notice remains posted in conspicuous locations within the DFCI inpatient hospital, (b) a survey of inpatients to evaluate whether they recall receiving the Notice, (c) a review of inpatient medical records to determine whether staff documented supplying inpatients with the Notice, (d) a survey of staff to confirm their understanding of how patient complaints and grievances are to be handled, (e) confirmation with Hospital #2 that patients have not been erroneously directed to Hospital #2 P/FR department for assistance, (f) evaluation of whether DFCI’s P/FR’s office is promptly responding to inpatient complaints/grievances, consistent with applicable Institute policy, (g) trends of inpatient complaints/grievances, and (h) a review of performance improvement plans, where appropriate. These POC-specific auditing and monitoring activity reports will be presented to the QI/RM Committee for the longer of one (1) year or until Substantial Compliance is achieved for four (4) consecutive quarters. 13 Independent Medical Record Service As described in Tags A431 and A432, beginning at its December 15, 2016 meeting, the Board Audit and Compliance Committee began receiving quarterly auditing and monitoring activities reports on the medical record service corrective actions. The reports include: (a) an evaluation of whether DFCI’s Health Information Services Department was appropriately responsible for medical record service duties (e.g., storage, ROI and chart completion), (b) an evaluation of whether staff can locate and differentiate patients in the EMR for patients admitted to the DFCI inpatient hospital, and (c) an evaluation of whether the DFCI medical record is complete and remains separate from Hospital #2 for each admission. These POC-specific auditing and monitoring activity reports will be presented to the Audit and Compliance Committee for the longer of one (1) year or until Substantial Compliance is achieved for four (4) consecutive quarters. 4. Responsible Leader DFCI Board of Trustees Chair 14 Additional Information about inpatient hospital policies and procedures 1. Corrective Action As of November 21, 2016, DFCI prepared and published a separate and independent DFCI Inpatient Hospital Policy Manual (Manual) to govern the care provided in the DFCI inpatient hospital. The Manual includes approximately 1,100 policies. DFCI clinical and administrative staff prepared, reviewed and approved, including review and approval by applicable clinical and administrative committees, such as the Institute’s Medical Staff Executive Committee and its Nursing Executive Council. As of October 6, 2016, DFCI completed and published separate and independent patient rights policies applicable to DFCI’s inpatient hospital. These policies are part of the newly established Manual. See Tag A118 for additional information. As of September 26, 2016, DFCI completed and published separate and independent blood products administration policies applicable to DFCI’s inpatient hospital. These policies are part of the newly established Manual. See Tags A398 and A409 for additional information. The QI/RM Committee approved management’s process for adopting the Manual (including patient rights policies: 9.04, Patient Complaint/Grievance/Request Management Process Policy and 9.14, Patient Rights and Responsibilities Notice Policy, and the blood product administration policies) on December 9, 2016. As described in Tag A115, in response to DPH’s October 21, 2016 letter asking that we clarify the “Patient Rights policies being signed by two different committees but not the Governing Body,” these two patient rights policies (Policies 9.04 and 9.14) were presented to two management-level committees – the Medical Staff Executive Committee and the Policy Review Team for review and approval, consistent with standard policy approval processes at DFCI. Further, as described above, DFCI’s Board QI/RM Committee approved management’s process for adopting the Manual (including Policies 9.04 and 9.14 and the blood product administration policies) on December 9, 2016. DFCI hosts the independent Manual on its policy manual intranet site. This site is available to all DFCI staff, including those staff members providing care in DFCI’s inpatient hospital. See Attachment A043-02: Screenshots of DFCI Inpatient Hospital Policy Manual location. 2. Communication/Education In response to DPH’s October 21, 2016 letter to “[p]rovide the State Agency a detailed timeframe of the roll out of the new policies, includ[ing] how staff are being educated on any changes,” our rollout, training and education activities are as follows: The new separate and independent Manual was “live” in its entirety on our internal policy manual site as of November 21, 2016. See Attachment A043-03: Table of Contents of New Inpatient Hospital Policy Manual. 15 Training and education of applicable clinical and administrative staff on the Manual was 99% complete as of February 28, 2017 and will be completed by March 31, 2017.1 Training and education was supplied by DFCI staff through a combination of in-person and electronic educational modalities, including HealthStream training and communication blasts. Training and education was mandatory and attendance/participation documented. Further in response to the DPH’s October 21, 2016 letter regarding policy changes that may affect patients and how DFCI is informing patients of such changes – as described above, for nearly all of the policies in the Manual, the policies document DFCI’s existing processes, so the impact to patients has been minimal. DFCI informs patients of material policy changes, as appropriate. For example, as described in Tag A115, DFCI has assumed responsibility of inpatient complaints and grievances. As of October 4, 2016, DFCI provided inpatients with the Institute’s Patient Rights and Responsibilities Notice and informed inpatients how to contact DFCI’s Patient and Family Relations office with any complaints or grievances. 3. Monitoring of Compliance Beginning March 1, 2017 and monthly thereafter, DFCI’s clinical and quality staff will interview a sample of fifteen (15) inpatient clinical staff (including nurses) and fifteen (15) inpatient administrative staff to evaluate such staff’s: (1) ability to locate the Institute’s inpatient hospital policies, and (2) substantive knowledge of the Institute’s inpatient hospital policies. This POCspecific monitoring will continue for the longer of one (1) year or until Substantial Compliance is achieved for four (4) consecutive quarters. Results of the monitoring are reported to the Executive POC Committee on a quarterly basis at minimum and to the QI/RM Committee at each meeting during the monitoring period. At a minimum, such reports will be made on March 31, 2017, April 28, 2017, June 29, 2017, July 27, 2017, September 29, 2017, October 27, 2017 and December 8, 2017 to the QI/RM Committee. The reports include a description of any non-compliance and how such activities were promptly remedied, if applicable. Any identified instances of noncompliance are immediately reported to the DFCI CMO and CNO, who ensure there is prompt remedial action. 4. QAPI This POC is identified as a QAPI Plan priority, and progress toward commitments set forth in the POC is being monitored through the QAPI program. For each action in the POC, DFCI has identified the following reporting structure: (i) reporting to the Executive POC Committee to ensure coordinated leadership oversight and accountability for sustained compliance with all POC commitments, and (ii) reporting to committees of the Board of Trustees to ensure governing body oversight. Overall progress on the POC is monitored by the QI Committee and 1 DFCI was able to accelerate the training and education on the new Inpatient Policy Manual, because the adopted policies were similar to Hospital #2 policies, which DFCI had previously prepared jointly with Hospital #2. Thus, the new Inpatient Policy Manual documents existing Institute policy, of which DFCI staff know and understand. 16 the QI/RM Committee in their respective roles in overseeing QAPI function. See Attachment A043-01: POC Governing Body Reporting Figure and Attachment A263-02: QAPI POC Projects. To date, reports on POC progress have been presented to the QI Committee on February 2, 2017 and February 28, 2017, and to the QI/RM Committee on December 9, 2016 and February 3, 2017. In addition, an update was provided to the Board of Trustees on January 30, 2017. 5. Responsible Leader DFCI Senior Vice President of Institute Operations 17 Tag A083 Contracted Services Completion Date – December 31, 2016 1. Corrective Action As stated in Tag A043 above, DFCI’s Board of Trustees is responsible for providing oversight to ensure that all services purchased under arrangement for the inpatient hospital (contracted services) are provided appropriately and in alignment with quality and performance standards developed by DFCI. This oversight will be provided through integration of contracted services into the QAPI Plan and process, which involves enhanced reporting relationships between the DFCI staff providing front-line and executive-level monitoring and oversight and the QI/RM Committee. DFCI’s Chief Medical Officer and Chief Nursing Officer are responsible for the provision of patient care services provided in the hospital by DFCI employees and services purchased under arrangement. Each DFCI contracted service agreement is subject to thoughtful development and periodic monitoring to ensure compliance with DFCI’s expectations of service performance. DFCI employs a structure to ensure that contracted services are closely monitored by DFCI staff. Each contracted service agreement has a designated DFCI business or clinical owner who is a DFCI employee with responsibility for overseeing the day-to-day operations of the specific contracted service (each a “DFCI Service Owner”). As of November 2016, each DFCI Service Owner was aligned with one of three DFCI executive sponsors who is responsible for overseeing contracted services: the DFCI Chief Nursing Officer, the DFCI Senior Vice President of Institute Operations or the DFCI Chief Medical Officer (each, a “DFCI Executive Sponsor”). Each DFCI Executive Sponsor is a member of the QI Committee. DFCI’s assessment of contracted services included a detailed review and clarification of the scope of services provided to the DFCI inpatient hospital and refinement of unique and discretely measurable quality indicators. Working together, the DFCI Service Owners and DFCI Executive Sponsors constitute a framework within DFCI to monitor and oversee performance of contracted services in an ongoing manner. Each contracted service agreement, or service level arrangement attached thereto, includes quality indicators that enable performance monitoring by DFCI. Each DFCI Service Owner, in collaboration with the Director of Hospital Administration, is responsible for periodic collection and analysis of unique quality indicators associated with the specific services under their purview, as identified in each contracted service agreement or attached service level arrangement. The DFCI Service Owner is also responsible for timely assessment and remediation of any inpatient service performance discrepancies, tracking issues and promptly reporting to the responsible DFCI Executive Sponsor on a regular basis. Any performance issues that cannot be resolved by the DFCI Service Owners are escalated to the appropriate DFCI Executive Sponsor. To facilitate DFCI’s ongoing monitoring and oversight of contracted service agreements, the QI Committee will receive quarterly reports on contracted services from the DFCI Executive Sponsors commencing with the period ending March 31, 2017. Each quarterly report will include the quality indicator detail collected from the DFCI Service Owners and analysis of each service provider’s compliance with such quality indicators. Already, reports from certain 19 contracted services have been reported into the DFCI QAPI program. The DFCI Executive Sponsors will include each DFCI Service Owner’s summary in the quarterly reports presented to the QI Committee. To the extent that any service deficiencies are identified (and that have not been appropriately resolved by the DFCI Service Owner or DFCI Executive Sponsor), the QI Committee will identify and establish performance improvement plans to address these deficiencies, as the QI Committee deems necessary. Such plans will be implemented by the DFCI Service Owner and the contracted service provider. The QI Committee will review and monitor new and ongoing performance improvement plans for contracted services. In addition, the QI Committee will report at least annually to the QI/RM Committee on the current status of all contracted services, which report will include information on whether each service provider is meeting performance and quality indicators, and on any performance improvement activities. Based upon these reports, the QI/RM Committee will oversee the DFCI Executive Sponsors’ and the QI Committee’s implementation of corrective actions or improvement activities pertaining to contracted services. As needed, the QI/RM Committee will receive additional follow-up reports from the DFCI Executive Sponsors and/or the QI Committee identifying the outcomes of such corrective actions or improvement activities. A Co-Chair of the QI/RM Committee will provide an annual report to the Board of Trustees on the QI/RM Committee’s oversight of contracted services. A complete list of contracted services (Inpatient Contracted Services Summary) is attached as Attachment A083-01: Inpatient Hospital Contracted Services Summary. Additionally, the executed contracted service agreements are attached as Attachments A083-02 to A083-08. 2. Communication/Education On October 24, 2016, the Chief Governance Officer and special counsel provided in-person refresher education to the Board of Trustees regarding its critical role in and responsibility for independently evaluating and overseeing the quality, safety, performance and independence of contracted services. Beginning on November 8, 2016, DFCI Executive Sponsors educated all DFCI Service Owners regarding their responsibilities in monitoring compliance with contracted services requirements, evaluating quality and performance indicators and reports for the contracted services, monitoring performance improvement programs and corrective action plans for deficient contracted services and escalating any performance concerns to the DFCI Executive Sponsor and QI Committee. These education efforts focused on reviewing processes to ensure compliance with the commitments set forth here and in Tag A273. Additional education was provided at a general management meeting on December 15, 2016, with follow-up through email communications for personnel unable to attend this meeting. 3. Monitoring of Compliance In coordination with DFCI’s Quality and Patient Safety Department, the Director of Hospital Administration ensures that the DFCI Service Owners are collecting, evaluating and appropriately reporting the data to monitor ongoing performance of contracted services. DFCI’s Chief Operating Officer or her designee monitors the ongoing assessment of all contracted services and associated reporting to DFCI Executive Sponsors to ensure continued compliance with respect to this aspect of the POC. 20 This POC-specific monitoring is conducted on a quarterly basis for the longer of one (1) year or until Substantial Compliance is achieved for four (4) consecutive quarters. Results of the monitoring are reported quarterly to the Executive POC Committee and to the QI/RM Committee. At a minimum, such quarterly reports will be made on April 28, 2017, July 27, 2017, October 27, 2017 and December 8, 2017 to the QI/RM Committee. Any identified instances of noncompliance are immediately reported to the Chief Operating Officer, who ensures there is prompt remedial action. After completion of this POC-specific monitoring, the QI/RM Committee will continue in its role of overseeing all contracted services. 4. QAPI This POC is identified as a QAPI Plan priority, and progress toward commitments set forth in the POC is being monitored through the QAPI program. For each action in the POC, DFCI has identified the following reporting structure: (i) reporting to the Executive POC Committee to ensure coordinated leadership oversight and accountability for sustained compliance with all POC commitments, and (ii) reporting to committees of the Board of Trustees to ensure governing body oversight. Overall progress on the POC is monitored by the QI Committee and the QI/RM Committee in their respective roles in overseeing QAPI function. See Attachment A043-01: POC Governing Body Reporting Figure and Attachment A263-02: QAPI POC Projects. To date, reports on POC progress have been presented to the QI Committee on February 2, 2017 and February 28, 2017, and to the QI/RM Committee on December 9, 2016 and February 3, 2017. In addition, an update was provided to the Board of Trustees on January 30, 2017. 5. Responsible Leader DFCI Chief Operating Officer 21 42 CFR 482.13 Patient Rights 22 mans Tag A115 Patient Rights Completion Date – October 6, 2016 1. Corrective Action Dana-Farber Cancer Institute (DFCI or the Institute) is committed to continuing to protect and promote each patient’s rights in accordance with the COPs. To ensure compliance with the Patient Rights Condition, on October 4, 2016, DFCI implemented two pertinent patient rights policies: A new policy “Patient Rights and Responsibilities Notice Policy” (Policy 9.14) was approved on September 19, 2016, which sets forth the policy and procedure for DFCI’s provision of its existing independent patient rights and responsibilities notice to inpatients (and outpatients), the Patient Rights and Responsibilities Notice (English and Spanish language versions) (collectively referred to herein as the “Notice”). See Attachment A115-01. A revised policy, “Patient Complaint/Grievance/Request Management Process Policy” (Policy 9.04) was approved on September 19, 2016, which describes how DFCI will promptly investigate and handle all patient (inpatient and outpatient) complaints and grievances. See Attachment A115-02. On October 4, 2016, DFCI conspicuously posted its Notice See Attachments A115-03 and A115-04 in the DFCI inpatient hospital to notify our inpatients of their rights. The Notice was revised to reflect that DFCI patients have the right to contact the applicable Quality Improvement Organization (QIO) (i.e., Livanta) with a complaint regarding DFCI’s quality of care or disagreement with a coverage decision. Since October 4, 2016, DFCI provides its inpatients (or, where appropriate, providing to the patient’s representative) a copy of the Notice. During these direct one-on-one interactions with patients (or their representative, where appropriate), DFCI informs inpatients that they are being provided with a Notice of their rights and responsibilities, recommending that they review this information and pointing out the section related to how to file a complaint or grievance. Consistent with the revisions to Policy 9.04, DFCI’s Patient/Family Relations (P/FR) staff assumed responsibility for DFCI inpatient hospital patient complaints, grievances and requests on October 4, 2016. Also, beginning on October 4, 2016, as required by Policies 9.04 and 9.14, when a patient has a complaint or grievance, clinical and administrative staff are required to assist the patient by either: (1) directing DFCI inpatients and their families to DFCI’s P/FR office for assistance, or (2) contacting the DFCI P/FR office directly for assistance. As described in Tag A043, in response to DPH’s October 21, 2016 letter to clarify the “Patient Rights policies are being signed by two different committees but not the Governing body”, the two (2) aforementioned patient rights policies were presented to two (2) management-level 24 committees – the Medical Staff Executive Committee and the Policy Review Team for review and approval. DFCI’s Board Committee on Quality Improvement and Risk Management (QI/RM Committee) approved management’s process for adopting an Hospital Inpatient Policy Manual (Manual) (including patient rights policies: 9.04, Patient Complaint/Grievance/Request Management Process Policy and 9.14, Patient Rights and Responsibilities Notice Policy) on December 9, 2016. In response to DPH’s October 21, 2016 letter as to “how much of the patient rights policies have been re-written and approved since 8/4/16?”, as described above, two patient rights policies have been approved by management since August 4, 2016. Specifically, the two (2) aforementioned policies, 9.04 and 9.14, were approved on September 19, 2016 with a go-live date of October 4, 2016. No other patient rights-specific policies were developed and approved by management since August 4, 2016. However, as described in greater detail in Tag A043, on November 21, 2016, DFCI completed and published a separate and independent Manual to govern the care provided in the DFCI inpatient hospital. The Manual includes more than 1,100 policies (including, for example, patient rights-related policies such as visitation guidelines, abuse reporting, restraints) that DFCI clinical and administrative staff prepared, reviewed and approved, including review and approval by appropriate clinical and administrative bodies, such as the Institute’s Medical Staff Executive Committee and its Nursing Executive Council. Training and education on the inpatient hospital manual was 99% complete as of February 28, 2017 and will be 100% complete by March 31. 2017. In response to DPH’s October 21, 2016 letter to “clarify the relationship that DFCI has with the DFCCC [locations] purchased in 2014”, Dana-Farber Community Cancer Care (DFCCC) is a wholly owned subsidiary of DFCI. DFCCC is comprised of three physician office locations. These locations are not hospital-licensed facilities (neither inpatient nor outpatient). Therefore, Policies 9.04 and 9.14 that were reviewed by CMS/DPH exclude DFCCC. See our response to Tag A118 for additional detail regarding these corrective actions. 2. Communication/Education Communication and education on Policies 9.04 and 9.14 has been completed. Specifically, three groups of staff members required education: Staff responsible for managing inpatient complaints and grievances: DFCI P/FR staff were educated by the DFCI P/FR Program Manager in-person on Policies 9.04 and 9.14 on September 29, 2016. Training and education were mandatory and completion was documented. See Attachment A115-05: Training Material on 9.04 and 9.14 for P/FR and Applicable Staff. Training for staff who are providing inpatients with, and informing inpatients about, the Patient Rights Notice and on Policies 9.04 and 9.14: Staff completed in-person training on September 28, 29, and 30, 2016. Training and education were mandatory and completion was documented. See Attachment A115-05: Training Material on 9.04 and 9.14 for P/FR and Applicable Staff. 25 Health care providers, support and administrative staff providing care in the DFCI inpatient hospital: These staff members were educated by the DFCI P/FR Program Manager by September 30, 2016 (via e-mail with confirmed receipt or HealthStream course) see Attachment A115-06: Training Material for Providers, Support and Administrative Staff on Policies 9.04 and 9.14. Training and education were mandatory and completion was documented. On a going forward basis, new staff will also be educated on these policies, as appropriate. This departmental education will be provided based on staff roles and responsibilities. See response in Tags A116 and A118 for additional detail regarding these training and education activities. 3. Monitoring of Compliance DFCI’s Quality and Patient Safety Department monitors activities to ensure compliance with Policies 9.04 and 9.14. Auditing and monitoring activities by this department include: (a) confirmation that the Notice remains posted in conspicuous locations within the DFCI hospital inpatient, (b) on a monthly basis speaking with a random sample of thirty (30) inpatients to inquire whether they received the Notice and information regarding the DFCI patient complaint/grievance process, (c) on a monthly basis auditing a random sample of thirty (30) inpatient hospital medical records to determine whether hospital staff documented supplying patients with this information, (d) surveying (with tracked responses) twenty (20) random staff members to confirm their understanding of how patient complaints and grievances are to be handled, and (e) confirming with Hospital #2 that patients have not been erroneously directed to Hospital #2 P/FR department for complaint and grievance assistance. Results of the monitoring were reported to the Executive POC Committee monthly beginning on December 15, 2016. Beginning in March 2017, results will be reported to this committee on a quarterly basis and will continue for the longer of one (1) year or until “Substantial Compliance” is achieved for three (3) consecutive quarters. “Substantial Compliance,” as defined throughout this POC, means a collective 90% compliance for those indicators monitored in any given Tag. Results have been presented to the QI Committee on February 2, 2017 and February 28, 2017, and to the QI/RM Committee on December 9, 2016 and February 3, 2017. Results will continue to be reported to the QI Committee and to the Board of Trustees QI/RM Committee on a quarterly basis for the longer of one (1) year or until Substantial Compliance is achieved for three consecutive quarters. At a minimum, such quarterly reports will be made on April 28, 2017, July 27, 2017, and October 27, 2017. Any identified instance of noncompliance will be immediately reported to the DFCI Chief Quality Officer (CQO), who will ensure there is prompt remedial action. Please see Attachment A263-02: QAPI POC Projects for monitoring results from October 2016 through February 2017. For the month of February 2017, the monitoring results are as follows: Conspicuous notice: The DFCI inpatient hospital environment was surveyed in February 2017, the conspicuous posting of the Notice in the DFCI inpatient hospital was confirmed. 26 Patient provision of Notice: DFCI conducted an audit of thirty (30) random inpatients (in the month of February), asking inpatients “Do you recall receiving the Patient Rights Notice? Here is what it looks like.” Thirty (30) patients responded affirmatively (100%). Documentation of provision of Notice: DFCI conducted an audit of thirty (30) random inpatients (in the month of February) to evaluate whether staff had appropriately documented the provision of the Notice in the EMR. Documentation in the EMR of the provision of the Notice was completed for thirty (30) admissions (100%). Staff understanding of 9.04 and 9.14: Beginning February 7, 2017 through February 16, 2017, an electronic survey was distributed to twenty-four (24) random DFCI inpatient hospital staff to evaluate their understanding of Policies 9.04 and 9.14. Twenty-three (23) staff members answered all three questions correctly (96%). Appropriate direction of inpatient complaints/grievances: DFCI P/FR office inquires weekly with Hospital #2 to determine whether any complaints/grievances were initially reported to Hospital #2. In February 2017, one inpatient complaints/grievances was identified as being erroneously routed to Hospital #2. 4. QAPI This POC is identified as a QAPI Plan priority, and progress toward commitments set forth in the POC is being monitored through the QAPI program. For each action in the POC, DFCI has identified the following reporting structure: (i) reporting to the Executive POC Committee to ensure coordinated leadership oversight and accountability for sustained compliance with all POC commitments, and (ii) reporting to committees of the Board of Trustees to ensure governing body oversight. Overall progress on the POC is monitored by the QI Committee and the QI/RM Committee in their respective roles in overseeing QAPI function. See Attachment A043-01: POC Governing Body Reporting Figure and Attachment A263-02: QAPI POC Projects. To date, reports on POC progress have been presented to the QI Committee on February 2, 2017 and February 28, 2017, and to the QI/RM Committee on December 9, 2016 and February 3, 2017. In addition, an update was provided to the Board of Trustees on January 30, 2017. 5. Responsible Leader DFCI Chief Quality Officer (CQO), assisted by the DFCI Risk Manager 27 mantis Tag A116 Patient Rights: Notice of Rights Completion Date – October 6, 2016 1. Corrective Action DFCI is committed to continuing to protect and promote each patient’s rights. To ensure compliance with the Patient Rights Condition, on October 4, 2016, DFCI implemented two pertinent patient rights policies: A new policy, “Patient Rights and Responsibilities Notice Policy” (Policy 9.14) see Attachment A115-01, was approved on September 19, 2016, which sets forth the policy and procedure for DFCI’s provision of its existing independent patient rights and responsibilities notice to inpatients (and outpatients). A revised policy, “Patient Complaint/Grievance/Request Management Process Policy” (Policy 9.04) see Attachment A115-02, was approved on September 19, 2016, which describes how DFCI will promptly investigate and handle all patient (inpatient and outpatient) complaints and grievances. On October 4, 2016, DFCI conspicuously posted its Patient Rights and Responsibilities Notice (English and Spanish language versions) (collectively referred to herein as the “Notice”) see Attachments A115-03 and A115-04 in the DFCI inpatient hospital to notify our inpatients of their rights. The Notice was revised to reflect that DFCI patients have the right to contact Livanta with a complaint regarding DFCI’s quality of care or disagreement with a coverage decision. Since October 4, 2016, DFCI provides its inpatients (or, where appropriate, providing to the patient’s representative) a copy of the Notice. During these direct one-on-one interactions with patients (or their representative, where appropriate), DFCI informs inpatients that they are being provided with a Notice of their rights and responsibilities, recommending that they review this information and pointing out the section related to how to file a complaint or grievance. Consistent with the revisions to Policy 9.04, DFCI’s Patient/Family Relations (P/FR) staff assumed responsibility for DFCI inpatient hospital patient complaints and grievances and on October 4, 2016. Also, beginning on October 4, 2016, as dictated required by Policies 9.04 and 9.14, when a patient has a complaint or grievance, clinical and administrative staff are required to assist the patient by either: (1) directing DFCI inpatients and their families to DFCI’s P/FR office for assistance, or (2) contacting the DFCI P/FR office directly for assistance. Beginning October 4, 2016 DFCI staff document in the patient’s medical record that the Notice was provided and discussed with the patient (or their representative, where appropriate), including any relevant details related to providing the Notice. The EMR automatically captures the auditing details, including the staff identifier, date, and time of this documentation. 29 2. Communication/Education Communication and education on Policies 9.04 and 9.14 has been completed. Specifically, three groups of staff members required education: Staff responsible for managing inpatient complaints and grievances: DFCI P/FR staff were educated by the DFCI P/FR Program Manager in-person on Policies 9.04 and 9.14 see A115-05: Training material on 9.04 and 9.14 for P/FR and applicable staff on September 29, 2016. Training and education were mandatory and completion was documented. The training and education pertained to how DFCI’s P/FR staff oversee, address, manage and respond to inpatient complaints and grievances. Training for staff who are providing inpatients with, and informing inpatients about, the Patient Rights Notice and on Policies 9.04 and 9.14: Staff completed in-person training on September 28, 29, and 30, 2016. See A115-05: Training material on 9.04 and 9.14 for P/FR and applicable staff. Training and education were mandatory and completion was documented. The training and education reviewed how to communicate with patients regarding their rights described in the Notice, how to supply patients (or their representative) with the Notice, how patients can contact DFCI P/FR office for assistance, how to document in the EMR the provision of, and education on, the Notice, and the physical location of the newly posted Notice. An EMR “tip sheet” was prepared for staff as a reference tool on how to document the provision of the Notice to patients. Staff members were also educated on ensuring appropriate communication with diverse patient populations. Patients’ preferred language for medical discussions is displayed on the report staff uses to identify patients who need to be presented with the Patients’ Rights Notice. This allows staff to bring a translated Notice if available or prepare to work with an interpreter. Health care providers, support and administrative staff providing care in the DFCI inpatient hospital: These staff members were educated by the DFCI P/FR Program Manager by September 30, 2016 (via e-mail with confirmed receipt or HealthStream course) see Attachment A115-06: Training Material for Providers, Support and Administrative Staff on Policies 9.04 and 9.14. Training and education were mandatory and completion was documented. The training and education covered Policies 9.04 and 9.14, including how DFCI P/FR’s office oversees and manages DFCI inpatient complaints and grievances, how to contact DFCI’s P/FR’s office, the physical location of the newly posted Notice, how to assist staff providing inpatients with, and informing inpatients of, the Notice. On a going forward basis, new staff will also be educated on these policies, as appropriate. This departmental education will be provided based on the staff roles and responsibilities. 3. Monitoring of Compliance DFCI’s Quality and Patient Safety Department monitors activities to ensure compliance with Policies 9.04 and 9.14. Auditing and monitoring activities by this department include: (a) confirmation that the Notice remains posted in conspicuous locations within the DFCI hospital inpatient location, (b) on a monthly basis speaking with a random sample of thirty (30) inpatients 30 to inquire whether they received the patients right notice and information regarding the DFCI patient complaint/grievance process, (c) on a monthly basis auditing a random sample of thirty (30) inpatient hospital medical records to determine whether hospital staff documented supplying patients with this information, (d) surveying (with tracked responses) twenty (20) random staff members to confirm their understanding of how patient complaints and grievances are to be handled, and (e) confirming with Hospital #2 that patients have not been erroneously directed to Hospital #2 P/FR department for complaint and grievance assistance. Results of the POC-specific monitoring were reported to the Executive POC Committee monthly beginning on December 15, 2016. Beginning in March 2017, results will be reported to this committee on a quarterly basis and will continue for the longer of one (1) year or until Substantial Compliance is achieved for three (3) consecutive quarters. Results have been presented to the QI Committee on February 2, 2017 and February 28, 2017, and to the QI/RM Committee on December 9, 2016 and February 3, 2017. Results will continue to be reported to the QI Committee and to the Board of Trustees QI/RM Committee on a quarterly basis for the longer of one (1) year or until Substantial Compliance is achieved for three consecutive quarters. At a minimum, such quarterly reports will be made on April 28, 2017, July 27, 2017, and October 27, 2017. Of note, data on patient complaints will be trended to highlight the most common types of complaints. Such report outs will also include performance improvement plans to ensure the Institute is meeting patient rights. In addition, summaries of cases are included in the reports to illustrate the complexity of specific cases. Any identified instances of noncompliance will be immediately reported to the DFCI CQO, who will ensure there is prompt remedial action. Please see Attachment A263-02: QAPI POC Projects for monitoring results from October 2016 through February 2017. For the month of February 2017, the monitoring results are as follows: Conspicuous notice: The DFCI inpatient hospital environment was surveyed in February 2017, the conspicuous posting of the Notice in the DFCI inpatient hospital was confirmed. Patient provision of Notice: DFCI conducted an audit of thirty (30) random inpatients (in the month of February), asking inpatients “Do you recall receiving the Patient Rights Notice? Here is what it looks like.” Thirty (30) patients responded affirmatively (100%). Documentation of provision of Notice: DFCI conducted an audit of thirty (30) random inpatients (in the month of February) to evaluate whether staff had appropriately documented the provision of the Notice in the EMR. Documentation in the EMR of the provision of the Notice was completed for thirty (30) admissions (100%). Staff understanding of 9.04 and 9.14: Beginning February 7, 2017 through February 16, 2017, an electronic survey was distributed to twenty-four (24) random DFCI inpatient hospital staff to evaluate their understanding of Policies 9.04 and 9.14. Twenty-three (23) staff members answered all three questions correctly (96%). Appropriate direction of inpatient complaints/grievances: DFCI P/FR office inquires weekly with Hospital #2 to determine whether any complaints/grievances were initially reported to Hospital #2. In February 2017, one inpatient complaint/grievance was identified as being erroneously routed to Hospital #2. 31 DFCI ensures that it is meeting the rights described in the Notice by educating staff and patients on the rights and responsibilities described in the Notice, and by having our P/FR staff manage complaints/grievances. Further, as described above, the Institute monitors this compliance by evaluating the complaints/grievances trends that are reported to our P/FR office. Updated or focused education are undertaken in response to trends or events tracked by P/FR. 4. QAPI This POC is identified as a QAPI Plan priority, and progress toward commitments set forth in the POC is being monitored through the QAPI program. For each action in the POC, DFCI has identified the following reporting structure: (i) reporting to the Executive POC Committee to ensure coordinated leadership oversight and accountability for sustained compliance with all POC commitments, and (ii) reporting to committees of the Board of Trustees to ensure governing body oversight. Overall progress on the POC is monitored by the QI Committee and the QI/RM Committee in their respective roles in overseeing QAPI function. See Attachment A043-01: POC Governing Body Reporting Figure and Attachment A263-02: QAPI POC Projects. To date, reports on POC progress have been presented to the QI Committee on February 2, 2017 and February 28, 2017, and to the QI/RM Committee on December 9, 2016 and February 3, 2017. In addition, an update was provided to the Board of Trustees on January 30, 2017. 5. Responsible Leader DFCI Chief Financial Officer 32 N?Bmiatl?ls?am Tag A118 Patient Rights: Grievances Completion Date – October 6, 2016 1. Corrective Action DFCI is committed to having an independent process for prompt resolution of patient grievances and informing each patient who to contact to file a grievance. To ensure continued compliance with this COP, on October 4, 2016, DFCI implemented two pertinent patient rights policies: A new policy, “Patient Rights and Responsibilities Notice Policy” (Policy 9.14) see Attachment A115-01, was approved on September 19, 2016, which sets forth the policy and procedure for DFCI’s provision of its existing independent patient rights and responsibilities notice to inpatients (and outpatients). A revised policy, “Patient Complaint/Grievance/Request Management Process Policy” (Policy 9.04) see Attachment A115-02, was approved on September 19, 2016, which describes how DFCI will promptly investigate and handle all patient (inpatient and outpatient) complaints and grievances. This policy was also revised to note that DFCI patients have the right to contact the QIO (e.g., Livanta) with a complaint regarding DFCI’s quality of care or disagreement with a coverage decision. On October 4, 2016, DFCI conspicuously posted its Patient Rights and Responsibilities Notice (English and Spanish language versions) (collectively referred to herein as the “Notice”) see Attachments A115-03 and A115-04 in the DFCI inpatient hospital to notify our inpatients of their rights. The Notice was revised to reflect that DFCI patients have the right to contact Livanta with a complaint regarding DFCI’s quality of care or disagreement with a coverage decision. Since October 4, 2016, DFCI is providing its inpatients (or, where appropriate, providing to the patient’s representative) with a copy of the Notice. During these direct one-on-one interactions with patients (or their representative, where appropriate), DFCI informs inpatients that they are being provided with a Notice of their rights and responsibilities, recommending that they review this information and pointing out the section related to how to file a complaint or grievance. Consistent with the revisions to Policy 9.04, DFCI’s Patient/Family Relations (P/FR) staff assumed responsibility for DFCI inpatient hospital patient complaints and grievances on October 4, 2016. Also, beginning on October 4, 2016, as required by Policies 9.04 and 9.14, when a patient has a complaint or grievance, clinical and administrative staff are required to assist the patient by either: (1) directing DFCI inpatients and their families to DFCI’s P/FR office for assistance, or (2) contacting the DFCI P/FR office directly for assistance. In response to DPH’s October 21, 2016 letter to “clarify in detail [the] independent process for prompt resolution of grievances”, the following describes the steps taken by DFCI’s P/FR staff for independently and separately resolving inpatient complaints/grievances: 34 As described in detail in Tag A116, staff were appropriately communicated with and trained on Policies 9.04 and 9.14 to ensure that inpatient complaints/grievances are directed to DFCI’s P/FR office. As described above, the “Patient Complaint/Grievance/Request Management Process Policy” was implemented on October 4, 2016, which includes the following steps if an inpatient complaint/grievance is received: a. DFCI inpatient hospital clinical or administrative staff promptly contact DFCI’s P/FR office to notify this office of an inpatient complaint/grievance or directs the DFCI inpatient and/or family to the DFCI P/FR office accordingly to file a complaint or grievance. b. DFCI P/FR staff promptly logs the complaint/grievance in DFCI’s complaint/grievance log. c. DFCI P/FR staff promptly contacts/meets with the inpatient and/or family to obtain complaint details to understand the complaint/grievance. d. DFCI P/FR staff then begins to promptly investigate the complaint/grievance. e. DFCI P/FR staff alerts the appropriate department/unit manager, director, clinical leader, and/or senior leader of the investigation. Further, depending on the nature of the incident, the DFCI responsible staff manager/director/leader may need to speak with the workforce member(s) involved (directly or indirectly) with the patient’s care about the investigation. f. In some instances, patients and families are invited to DFCI to meet with the patient’s care team, or a specific provider, and/or clinical leader, along with P/FR staff, to discuss elements of the grievance in further detail. g. DFCI P/FR staff and/or the appropriate DFCI staff manager/director/clinical leader/senior leader promptly remedies, to the extent feasible, the DFCI inpatient’s complaint/grievance. h. Every effort is made to resolve complaints/grievances within seven (7) days. If this is not possible, complaints/grievances must be resolved no later than thirty (30) business days from the receipt of the grievance, unless extenuating circumstances, such as complex issues, exist. In those circumstances, an exception will be permitted and the grievance must be closed no later than sixty (60) days from date of receipt. i. DFCI P/FR staff and/or appropriate manager/director/clinical leader/senior leader promptly notifies the DFCI inpatient and/or family as to how their complaint/grievance was investigated and remedied to ensure the patient’s needs were adequately met and the patient is satisfied. Depending on the nature of complaint/grievance, DFCI P/FR office and/or appropriate manager/director/clinical leader/senior leader communicates this information to the patient or complainant in writing and in many cases, verbally. j. Depending on the nature of the complaint/grievance, the appropriate DFCI manager/director/clinical leader/senior leader notifies the workforce member(s) involved in the complaint/grievance as to how the matter was resolved. 35 k. DFCI P/FR staff indicates the matter closed by documenting in its complaint/grievance log. l. When applicable, DFCI P/FR staff work with appropriate clinical and administrative staff to develop performance improvement plans to help prevent a similar grievance/complaint from recurring. Please refer to Policy 9.04 for greater detail around this process. See Attachment A115-02. 2. Communication/Education Communication and education activities regarding corrective actions to help ensure an independent process for prompt resolution of patient grievances and informing each patient whom to contact to file a grievance has been completed. Specifically: Staff responsible for managing inpatient complaints and grievances: DFCI P/FR staff were educated by the DFCI P/FR Program Manager in-person on Policies 9.04 and 9.14 see A115-05: Training material on 9.04 and 9.14 for P/FR and applicable staff on September 29, 2016. Training and education was mandatory and completion was documented. The training and education pertained to how DFCI’s P/FR staff oversee, address, manage and respond to inpatient complaints and grievances. Training for staff who are providing inpatients with, and informing inpatients about, the Patient Rights Notice and on Policies 9.04 and 9.14: Staff completed in-person training on September 28, 29, and 30, 2016. See A115-05: Training material on 9.04 and 9.14 for P/FR and applicable staff. Training and education were mandatory and completion was documented. The training and education reviewed how to communicate with patients regarding their rights described in the Notice, how to supply patients (or their representative) with the Notice, how patients can contact DFCI P/FR office for assistance, how to document in the EMR the provision of, and education on, the Notice, and the physical location of the newly posted Notice. An EMR “tip sheet” was prepared for staff as a reference tool on how to document the provision of the Notice to patients. Staff members were also educated in their respective sessions on how to ensure we are able to communicate patient rights to diverse patients. Patients’ preferred language for medical discussions is displayed on the report staff uses to identify patients who need to be presented with the Patients’ Rights Notice. This allows staff to bring a translated Notice if available or prepare to work with an interpreter. Health care providers, support and administrative staff providing care in the DFCI inpatient hospital: These staff members were educated by the DFCI P/FR Program Manager by September 30, 2016 (via e-mail with confirmed receipt or HealthStream course) see Attachment A115-06: Training Material for Providers, Support and Administrative Staff on Policies 9.04 and 9.14. Training and education were mandatory and completion was documented. The training and education covered Policies 9.04 and 9.14, including how DFCI P/FR’s office oversees and manages 36 DFCI inpatient complaints and grievances, how to contact DFCI’s P/FR’s office, the physical location of the newly posted Notice, how to assist staff providing inpatients with, and informing inpatients of, the Notice. Moving forward, new staff will also be educated on these policies, as appropriate. This departmental education will be provided based on the staff roles and responsibilities. 3. Monitoring of Compliance To ensure DFCI has an effective process for prompt resolution of patient grievances, we have incorporated inpatient complaints/grievances into our existing monitoring program. Specifically, the P/FR Program Manager presents to the Risk Manager (i.e., the supervisor of the P/FR office) on a weekly basis a summary of current/open complaints, timeline of initial follow-up, current status and ongoing follow-up. Open cases are followed on a weekly basis by the Program Manager and Risk Manager until resolution. The Risk Manager is apprised of the outcomes and resolutions of all complex cases on a weekly basis, and the Medical Director of Patient Safety & Risk Management is apprised of the same on a monthly basis. Results of the POC-specific monitoring described above were reported to the Executive POC Committee beginning February 28, 2017. Results will continue to be reported quarterly to the Executive POC Committee, the QI Committee and the QI/RM Committee for one year, and then yearly thereafter to the QI Committee and QI/RM Committee. Results have been presented to the QI Committee on February 2, 2017 and February 28, 2017, and to the QI/RM Committee on December 9, 2016 and February 3, 2017. At a minimum, such quarterly reports will be made on April 28, 2017, July 27, 2017, October 27, 2017 and December 8, 2017 to the QI/RM Committee. Such reports will also include performance improvement plans to ensure the Institute is promptly resolving inpatient complaints and grievances. 4. QAPI This POC is identified as a QAPI Plan priority, and progress toward commitments set forth in the POC is being monitored through the QAPI program. For each action in the POC, DFCI has identified the following reporting structure: (i) reporting to the Executive POC Committee to ensure coordinated leadership oversight and accountability for sustained compliance with all POC commitments, and (ii) reporting to committees of the Board of Trustees to ensure governing body oversight. Overall progress on the POC is monitored by the QI Committee and the QI/RM Committee in their respective roles in overseeing QAPI function. See Attachment A043-01: POC Governing Body Reporting Figure and Attachment A263-02: QAPI POC Projects. To date, reports on POC progress have been presented to the QI Committee on February 2, 2017 and February 28, 2017, and to the QI/RM Committee on December 9, 2016 and February 3, 2017. In addition, an update was provided to the Board of Trustees on January 30, 2017. 37 5. Responsible Leader DFCI Chief Quality Officer (CQO) 38 42 CFR 482.21 Quality Assessment and Performance Improvement 39 man Tag A263 QAPI Completion Date – December 31, 2016 1. Corrective Action Dana-Farber Cancer Institute (DFCI or the Institute) is committed to providing a robust and effective, hospital-wide quality assessment and performance improvement (QAPI) program that will measure, analyze and track process of care indicators and outcomes for all DFCI ambulatory and the inpatient hospital on an ongoing basis, whether provided directly by DFCI employees or furnished under contract or arrangement. This QAPI structure, which is independent of any other facility, is overseen by the Board of Trustees Committee on the Quality Improvement and Risk Management (QI/RM or QI/RM Committee). To ensure compliance with this Condition, DFCI has reorganized its QAPI structure as discussed in this POC. As set forth in more detail in the response to Tag A273, on October 21, 2016, DFCI updated its QAPI Plan to fully incorporate its licensed hospital inpatient services and to reflect its independence. At the request of DPH, the QAPI Plan was further updated to accurately reflect the POC monitoring structure and the integration of services purchased under arrangement for the inpatient hospital (contracted services) into the QAPI program. The final QAPI Plan was subsequently approved by QI/RM on December 9, 2016. See Attachment A263-01: QAPI Plan. The QAPI Plan outlines the following: QAPI purpose and guiding principles; QAPI scope, including management of patient safety and integration of the POC into the QAPI program; QAPI governance and leadership; Feedback, data systems and monitoring; Performance improvement process; Communication and evaluation. The QAPI Plan reflects DFCI’s independence in measuring, analyzing and tracking quality indicators and other aspects of performance, defines and incorporates quality indicator data according to definitions approved by the QI/RM Committee, specifies the frequency and detail of the data collection, and identifies processes for monitoring the effectiveness and safety of services and quality of care. These processes include creation of a new quality dashboard approved by the QI/RM Committee; centralized DFCI responsibility for collecting, analyzing, and presenting data in the dashboard; creation of a new Quality Improvement Committee (QI Committee) to review the dashboard, identify opportunities for performance improvement, monitor improvement, and report to the QI/RM Committee; and revision and approval of the written QAPI Plan. In response to DPH’s October 21, 2016 letter and related feedback to DFCI, DFCI clarified the role of the QI/RM Committee to specifically include oversight of all corrective measures identified in this POC. To achieve this objective, the POC is included in the QAPI Plan as a key performance improvement priority for DFCI. For each action in the POC, DFCI has identified the following reporting structure: (i) reporting to the Executive POC Committee to ensure 41 coordinated leadership oversight and accountability for sustained compliance with all POC commitments, and (ii) reporting to committees of the Board of Trustees to ensure governing body oversight. Overall progress on the POC has been and will continue to be monitored at least quarterly by the QI Committee and by the QI/RM Committee in their respective roles in overseeing QAPI function. See Attachment A043-01: POC Governing Body Reporting Figure. To facilitate this oversight, detailed quality improvement project documentation has been created for each monitoring component of the Plan of Correction. See Attachment A263-02: QAPI POC Projects. As set forth in greater detail in the response to Tags A083, A273 and A308, as of November 30, 2016, DFCI completed a thorough reassessment of contracted services. The DFCI Executive Sponsors (defined in Tag A273) provide executive oversight of contracted services. The DFCI Executive Sponsors, QI Committee, and the QI/RM Committee will receive regular reports regarding each contracted service, including quality indicators associated with the services, and on any related performance improvement plans. Already, reports from certain contracted services have been reported into the DFCI QAPI Program. The detailed plan for overseeing all contracted services was presented to the QI/RM on December 9, 2016. As set forth in greater detail in the response to Tag A286, as of October 31, 2016, DFCI has ensured that the hospital is, in all locations, independently identifying and reducing medical errors and adverse patient events, analyzing their causes and implementing preventative actions and mechanisms that include feedback and learning from throughout the hospital; preparing reports and dashboards for review by appropriate DFCI clinical leadership committees and the QI/RM Committee which include DFCI inpatient event and patient safety data; and ensuring consistent responsibility for implementing preventive or corrective actions for DFCI patients in all settings. Consistent with longstanding DFCI policy and practice, DFCI conducts ongoing review of safety events reported in the DFCI inpatient hospital and, as necessary, conducts investigations and root cause analyses for these events. See Attachment A263-03: Populated DFCI Quality Dashboard and Attachment A263-04: Inpatient Section of the DFCI Patient Safety Dashboard for data related to DFCI inpatient events and patient safety. As set forth in greater detail in the response to Tag A309, as of November 15, 2016, DFCI revised its performance improvement program to reflect its independence, including efforts to address priorities for improved quality of care and patient safety, ensuring that all improvement actions will be evaluated, and that improvement projects will be conducted annually, including defined improvement projects for DFCI ambulatory and inpatient care; creation of additional data and reports allowing appropriate DFCI clinical leadership committees to oversee and monitor performance, establish improvement plans, and monitor implementation of improvements in priority areas; all as overseen by the QI/RM Committee. See Attachment A263-01: QAPI Plan. As set forth in greater detail in the response to Tag A315, as of November 15, 2016, DFCI allocated appropriate resources to independently measure, assess, improve and sustain DFCI’s performance and reduce risks to patients, through establishment of the QI Committee; expanding the scope of the DFCI Pharmacy & Therapeutics Committee (also addressed in Tag A286); hired a dedicated staff position to oversee quality data collection, aggregation, reporting, and improvement activities for DFCI inpatient care; and revised the job descriptions for selected 42 Quality and Patient Safety Department staff to specify responsibility for quality and safety of DFCI inpatient services. See Attachment A263-05: Quality Improvement Committee Charter, Attachment A263-03: Populated DFCI Quality Dashboard, A263-06 DFCI Pharmacy and Therapeutics Committee Policy, A263-07 DFCI Pharmacy and Therapeutics Committee Roster and Attachment A263-08: Revised & Approved Job Descriptions. 2. Communication/Education As set forth in the responses to Tags A273, A286, A308, A309 and A315, DFCI implemented a broad reaching QAPI program and related education and communication encompassing DFCI clinical and administrative staff, the Board of Trustees and appropriate committees. 3. Responsible Leader DFCI Chief Quality Officer 43 Tag A273 Data Collection and Analysis Completion Date – December 31, 2016 1. Corrective Action DFCI is committed to ensuring and DFCI’s approved QAPI Plan reflects DFCI’s ongoing, independent commitment to measure, analyze, and track quality indicators and other aspects of performance that assess processes of care, hospital services and operations; and defines and incorporates quality indicator data according to standards approved by the QI/RM Committee that specify the frequency and detail of the data collection and monitoring of the effectiveness and safety of services and quality of care. DFCI revised its existing QAPI Plan and obtained approval by the QI/RM Committee on October 21, 2016, with further updates and QI/RM approval on December 9, 2016. See Attachment 263-01: QAPI Plan. Furthermore, the QAPI Plan reflects DFCI’s independent role in prioritizing, supporting, leading and evaluating clinical improvement activities for its inpatient and outpatient services, whether provided directly by DFCI employees or under contract or arrangement. As noted in Tag A263, the QAPI Plan integrates the commitments set forth in this POC. For each action in the POC, DFCI has identified the following reporting structure: (i) reporting to the Executive POC Committee to ensure coordinated leadership oversight and accountability for sustained compliance with all POC commitments, and (ii) reporting to committees of the Board of Trustees to ensure governing body oversight. Overall progress on the POC has been and will continue to be monitored by the QI Committee and the QI/RM Committee in their respective roles in overseeing QAPI function. See Attachment A043-01: POC Governing Body Reporting Figure QAPI and Contracted Services As part of DFCI’s ongoing revisions and clarification of services purchased under arrangement for the inpatient hospital (contracted services), DFCI contracts and agreements were refined to reflect DFCI’s independence in overseeing QAPI activities related to DFCI patients. The QI/RM Committee provides oversight to ensure that all contracted services are provided appropriately and in alignment with quality and performance standards developed by DFCI. This oversight is provided through integration of contracted services into the QAPI Plan and process, which involves reporting relationships between the DFCI staff providing front-line and executivelevel monitoring, and reporting to the QI/RM Committee. As described in Tag A083, each contracted service has a designated DFCI business or clinical owner who is a DFCI employee with responsibility for overseeing the day-to-day operations of the specific contracted service (each a “DFCI Service Owner”). As of November, 2016, each DFCI Service Owner was aligned with one of three DFCI executive sponsors who is responsible for overseeing contracted services: the DFCI Chief Nursing Officer, the DFCI Senior Vice President of Institute Operations or the DFCI Chief Medical Officer (each, a “DFCI Executive Sponsor”). Each DFCI Executive Sponsor is a member of the QI Committee. 45 DFCI’s assessment of contracted services included a detailed review and clarification of the scope of services provided to the DFCI inpatient hospital and refinement of unique and discretely measurable quality indicators. Working together, the DFCI Service Owners and DFCI Executive Sponsors constitute a framework within DFCI to monitor and oversee performance of contracted services in an ongoing manner. Each contracted services agreement, or service level arrangement attached thereto, includes quality indicators that enable performance monitoring by DFCI. Like all quality indicators associated with the QAPI Plan, these indicators were approved by the QI/RM on December 21, 2016, for integration into the QAPI monitoring process. Each DFCI Service Owner, in collaboration with the Director of Hospital Administration, is responsible for periodic collection and analysis of unique quality indicators associated with the specific services under their purview, as identified in each contracted services agreement or attached service level arrangement. The DFCI Service Owner is also responsible for timely assessment and remediation of any contracted service performance discrepancies, tracking issues and promptly reporting to the responsible DFCI Executive Sponsor at least quarterly. Any performance issues that cannot be resolved by the DFCI Service Owners are escalated to the DFCI Executive Sponsors. To facilitate DFCI’s ongoing monitoring and oversight of contracted services, the QI Committee will receive quarterly reports on contracted services from the DFCI Executive Sponsors for the period ending March 31, 2017. Each quarterly report will include the quality indicator detail collected from the DFCI Service Owners and analysis of each service provider’s compliance with such quality indicators. Already, reports from certain contracted services have been reported into the DFCI QAPI program. The DFCI Executive Sponsors will include each DFCI Service Owner’s summary in the quarterly reports presented to the QI Committee. To the extent that any service deficiencies are identified (and that have not been appropriately resolved by the DFCI Service Owner or DFCI Executive Sponsor), the QI Committee will identify and establish performance improvement plans to address the deficiency, as the QI Committee deems necessary. Such plans will be implemented by the DFCI Service Owner and the contracted service provider. The QI Committee will review and monitor new and ongoing performance improvement plans for contracted services. In addition, the QI Committee will report at least annually to the QI/RM Committee on the current status of all contracted services, which report will include information on whether the service provider is meeting performance and quality indicators, and on any performance improvement activities. Based upon these annual reports, the QI/RM Committee will oversee the DFCI Executive Sponsors’ and the QI Committee’s implementation of appropriate oversight of contracted services, including corrective actions or improvement activities. As needed, the QI/RM Committee will receive additional follow-up reports from the DFCI Executive Sponsors and/or the QI Committee identifying the outcomes of such corrective actions or improvement activities. A Co-Chair of the QI/RM will provide an annual report to the Board of Trustees on QI/RM Committee’s oversight of contracted services. QAPI Governance The Executive Committee of the Board of Trustees revised the charter of the QI/RM Committee on September 29, 2016, to specify that QI/RM has governing responsibility for DFCI’s quality assessment and performance improvement activities, which includes defining and monitoring 46 clinical performance measures for DFCI inpatient and ambulatory services. QI/RM documentation clarifies that DFCI Trustees are the only voting members of the QI/RM Committee. DFCI clinical and operational staff members who attend QI/RM meetings in a supporting role to provide information are identified as non-voting, non-member staff. See Attachment 273-01: Approved Revised QI/RM Committee Charter. When revising the QAPI Plan and enhancing the QAPI process, the QI/RM Committee and DFCI leadership determined that the activities previously overseen by the Quality Leadership Council (QLC) are now addressed by the QI Committee and are overseen directly by the QI/RM Committee. The QLC has been disbanded. QAPI Data Collection On October 21, 2016, the QI/RM Committee approved quality metrics for an enhanced DFCI Quality Dashboard, which incorporates new inpatient care metrics and refines existing metrics for measuring key performance indicators of quality, safety and clinical operations. For each metric in the DFCI Quality Dashboard, DFCI has documented (a) rationale, (b) data collection and analytic plan, including periodicity of data collection, (c) monitoring and review schedule by appropriate DFCI committees (the QI Committee and other committees such as Infection Control) and by QI/RM. Targets for performance are identified by the QI Committee. The metrics approved for the DFCI Quality Dashboard are included in the QAPI Plan. See Attachment 26301: QAPI Plan which includes the approved DFCI Quality dashboard metrics in the appendix. As reflected in the QAPI Plan, the revised DFCI Quality Dashboard includes metrics addressing the following quality priorities, among others: medication events, falls, pressure ulcers, pain assessment/education, transfusions, and hospital-associated infection. DFCI has achieved direct access to source data for the metrics through steps such as the development of electronic health record reports for DFCI’s inpatient hospital and the creation of DFCI-led audit programs. Immediately following approval of the DFCI Quality Dashboard by the QI/RM Committee on October 21, 2016, DFCI initiated data collection to populate the DFCI Quality Dashboard. See Attachment 263-03: Populated DFCI Quality Dashboard. The data source and periodicity of data collection for the DFCI Quality Dashboard is identified in the QAPI Plan. DFCI staff have responsibility for accessing, aggregating, and presenting the data in the DFCI Quality Dashboard. The DFCI Quality Dashboard is presented to the QI Committee, described below. This committee identifies and recommends areas for performance improvement, and monitoring improvement activities. The DFCI Quality Dashboard is reported to the QI/RM Committee at least quarterly, along with a report of performance improvement initiatives and progress. The 2016 DFCI Infection Control Plan was presented to the QI/RM Committee by the DFCI Epidemiologist and was approved by the Committee on October 21, 2016. The Infection Control Plan will be presented to QI/RM Committee annually for approval hereafter. QAPI Plan The QAPI Plan, previously titled “Quality Improvement Plan,” was revised in October 21, 2016 by the DFCI Quality and Patient Safety Department to reflect the above described changes, as well as DFCI’s exclusive responsibility for overseeing DFCI’s safety reporting systems, safety culture and just culture systems, Press Ganey Survey processes and performance improvement projects. As noted, monitoring of DFCI’s progress toward this POC is a QAPI priority for DFCI. 47 As the DFCI POC has been revised to reflect DFCI’s learning and to reflect specific requests from DPH, the QAPI Plan was further refined to accurately reflect the POC monitoring structure and the integration of contracted services into the QAPI program. This revised QAPI Plan was approved by QI/RM Committee on December 9, 2016. See Attachment 263-01: QAPI Plan. QI Committee DFCI ensures that appropriate DFCI committees are actively engaged in routine review of DFCI-wide performance data, in making recommendations for performance improvement, implementing performance improvement plans, and in ongoing monitoring of improvement priorities. To ensure that adequate resources are available to perform these duties, DFCI established an independent QI Committee on October 6, 2016, comprised of multidisciplinary clinical and operational representatives from DFCI inpatient and ambulatory care settings. A committee charter was created, and the QI Committee first met on October 26, 2016. See Attachment A263-05: Quality Improvement Committee Charter. As of November 15, 2016, the DFCI Quality Dashboard was populated and the QI Committee met on November 17, 2016 to review the data. To ensure detailed assessment of performance by subject matter experts, the QI Committee created a performance monitoring organizational structure and an associated reporting calendar. See Attachment A263-01: QAPI Plan - Appendices which includes the QI Committee organizational structure and reporting calendar. (In QAPI Plan Appendix D, note that solid lines indicate direct accountability and reporting obligations, while dotted lines indicate reporting obligations, but not direct accountability. All committees represented in Appendix D are DFCI committees). Through this performance monitoring organizational structure, performance data will be reviewed at defined periods and opportunities for improvement and recommended improvement plans escalated to the QI Committee. To ensure governing body oversight, the QI Committee reports to the QI/RM Committee at least quarterly. The QI/RM Committee reports quarterly to the Board of Trustees. 2. Communication/Education In October 2016, QI/RM Committee members, DFCI leadership and DFCI’s Quality and Patient Safety Department were all educated by the Chief Quality Officer on the revised charter of the QI/RM Committee, and the role of the QI Committee. Additionally, the QAPI Plan and Quality Dashboard were reviewed in detail and discussed with appropriate institutional leaders and with QI/RM members prior to the initial approval by the QI/RM Committee on October 21, 2016. In October 2016, DFCI’s Quality and Patient Safety Department oriented DFCI staff managers representing all disciplines and departments within DFCI regarding the revised QAPI Plan through email communication; written acknowledgement of receipt and understanding were obtained from all recipients. The 2016 Infection Control Plan was reviewed in detail, discussed with, and approved by the QI/RM Committee on October 21, 2016. QI/RM Committee minutes reflect these activities and attendance was documented. On October 26, 2016, members of the QI Committee attended an orientation and education session run by the Quality and Patient Safety Department. This session included review of the QI Committee charter, the DFCI Quality Dashboard, and the QAPI Plan. The orientation and 48 education session was mandatory and attendance was documented. One QI Committee member was not present and received an individual orientation from the Chief Quality Officer. On October 24, 2016, the Chief Governance Officer and special counsel provided in-person refresher education to the Board of Trustees regarding its critical role in and responsibility for overseeing the quality, safety, performance and independence of contracted services. Beginning on November 8, 2016, DFCI Executive Sponsors educated all DFCI Service Owners regarding their responsibilities in monitoring compliance with contracted services requirements, evaluating quality and performance indicators and reports for the contracted services, monitoring performance improvement programs and corrective action plans for deficient contracted services and escalating any performance concerns to the DFCI Executive Sponsor and QI Committee. These education efforts focused on reviewing processes to ensure compliance with the commitments set forth here and in Tag A083. Additional education was provided at a general management meeting on December 15, 2016, with follow-up through email communications for personnel unable to attend this meeting. 3. Monitoring of Compliance DFCI’s Quality and Patient Safety Department maintains the DFCI Quality Dashboard, and ensures that data are aggregated and reported per the defined schedule for each metric, and that reports are submitted to the QI Committee and to the QI/RM Committee consistent with this POC. DFCI’s Quality and Patient Safety Department ensures that the QI Committee meets per the defined schedule and records meeting minutes, and that commitments set forth in the QAPI Plan are met in an ongoing manner. In coordination with DFCI’s Quality and Patient Safety Department, the Director of Hospital Administration ensures that the DFCI Service Owners are collecting, evaluating and appropriately reporting the data to monitor ongoing performance of contracted services. The POC-specific monitoring will be conducted on a quarterly basis for the longer of one (1) year or until “Substantial Compliance” is achieved for four (4) consecutive quarters. “Substantial Compliance,” as defined throughout this POC, means a collective 90% compliance for those indicators monitored in any given Tag. Results of the monitoring have been and will continue to be reported quarterly to the Executive POC Committee and to the QI/RM Committee. Results of monitoring activities to date were reported to the Board of Trustees QI/RM Committee on December 9, 2016 and February 3, 2017. At a minimum, such quarterly reports will be made on April 28, 2017, July 27, 2017, October 27, 2017 and December 8, 2017 to the Board of Trustees QI/RM Committee. Any identified instances of noncompliance will be immediately reported to the DFCI Chief Quality Officer (for issues related to the DFCI Quality Dashboard or QI Committee activities) and Chief Operating Officer (for issues related to contracted services), who will ensure there is prompt remedial action. After completion of this POC-specific monitoring, the QI/RM Committee will continue in its role of overseeing all contracted services. 4. QAPI This POC is identified as a QAPI Plan priority, and progress toward commitments set forth in the POC is being monitored through the QAPI program. For each action in the POC, DFCI has identified the following reporting structure: (i) reporting to the Executive POC Committee to ensure coordinated leadership oversight and accountability for sustained compliance with all POC commitments, and (ii) reporting to committees of the Board of Trustees to ensure 49 governing body oversight. Overall progress on the POC is monitored by the QI Committee and the QI/RM Committee in their respective roles in overseeing QAPI function. See Attachment A043-01: POC Governing Body Reporting Figure and Attachment A263-02: QAPI POC Projects. To date, reports on POC progress have been presented to the QI Committee on February 2, 2017 and February 28, 2017, and to the QI/RM Committee on December 9, 2016 and February 3, 2017. In addition, an update was provided to the Board of Trustees on January 30, 2017. 5. Responsible Leader(s) DFCI Chief Quality Officer (responsible for QAPI), DFCI Chief Operating Officer (responsible for contracted services) 50 Tag A286 Patient Safety Completion Date – November 15, 2016 1. Corrective Action DFCI is committed to establishing and maintaining an independent QAPI program to identify and reduce medical errors and adverse events in its inpatient hospital. As such, DFCI: Is performing ongoing, independent review of safety events reported within the DFCI inpatient hospital and conducting investigations and root cause analyses for events that occur within the DFCI inpatient hospital as needed, consistent with longstanding DFCI policy and practice. Revised the existing DFCI Patient Safety Dashboard to include trended inpatient event data for DFCI’s inpatient hospital, which was approved at the QI/RM Committee on October 21, 2016. The Patient Safety Dashboard is reviewed quarterly by the QI/RM Committee. See Attachment 263-04: Inpatient Section of the Patient Safety Dashboard. Revised data reporting to the DFCI Infection Control Committee to include specific data for the DFCI inpatient hospital. At the August 19, 2016 Infection Control Committee meeting, quality measures assessing CLABSI, CAUTI, MRSA, VRE, and C. difficile for the DFCI inpatient hospital were presented and discussed. Review of these and other relevant data will continue. Going forward, the DFCI Infection Control Committee recommends infection control related improvements as needed and monitors all approved infection control related improvement activities for the DFCI inpatient hospital. Metrics monitored and improvement plans overseen by the Infection Control Committee are presented to the QI Committee and the QI/RM Committee at least annually. Revised the scope of the DFCI Pharmacy & Therapeutics Committee to include routine review of medication event data, and relevant inpatient pharmacy performance metrics, for the DFCI inpatient hospital. The Pharmacy & Therapeutics Committee meets on a monthly basis, and convenes more frequently if needed. See Attachment A263-06 DFCI Pharmacy and Therapeutics Committee Policy, A263-07 DFCI Pharmacy and Therapeutics Committee Roster and Attachment A273-02: Minutes of the September 2016 Pharmacy & Therapeutics Committee meeting and Attachment A273-03: Schedule of Meetings. At the October 16, 2016 Pharmacy & Therapeutics Committee meeting, quality measures related to medication events, pharmacist order review turnaround time, high priority medication turnaround time, percent dispenses from automated dispensing system, and barcode medication administration scanning compliance, all for the DFCI inpatient hospital, were presented and discussed. Metrics monitored and improvement plans overseen by the Pharmacy & Therapeutics Committee are presented to the QI Committee and the QI/RM Committee at least annually. DFCI routinely reviews data to identify and reduce medical errors, including errors related to medication events (with and without harm) and near misses. Various data sources are used to identify medical errors, with the primary source being the online safety event reporting system. These data for the inpatient hospital are reviewed in several committees, including the Inpatient 52 Medication Event Committee and the Pharmacy & Therapeutics Committee. Improvement plans are identified in these committee settings and escalated to the QI Committee. Following DFCI staff review, investigation, and root-cause analysis (as warranted), trends and specific events for the DFCI inpatient hospital are presented to the QI/RM Committee. Additionally, as noted in Tag A273, the revised DFCI Quality Dashboard (which is separate and distinct from the Patient Safety Dashboard) incorporates quality measures related to patient safety, and is reviewed quarterly by the QI/RM Committee. The DFCI Quality Dashboard was approved by the QI/RM Committee on October 21, 2016, and was first populated with data on November 15, 2016. See Attachment A263-03: Populated DFCI Quality Dashboard and Attachment A263-04: Inpatient Section of the DFCI Patient Safety Dashboard. As requested, the DFCI Quality Dashboard and the DFCI Patient Safety Dashboard are submitted to DPH on a quarterly basis until such date when all commitments identified in this POC are completed. As described in the response to Tag A273, effective September 29, 2016, the Executive Committee of the Board of Trustees revised the QI/RM charter documentation to clarify that DFCI Trustees are the only voting members of the QI/RM Committee. DFCI clinical and operational staff members who attend QI/RM meetings in a supporting role are appropriately identified as non-voting, non-member staff. See Attachment A273-01: Approved Revised QI/RM Committee Charter. In response to the observation that Hospital #2 serves as a member on DFCI’s Medical Staff Executive Committee, DFCI wishes to clarify that only individuals holding DFCI positions and representing DFCI medical staff are members of the Medical Staff Executive Committee. DFCI also wishes to clarify that all compliance and risk management tasks related to DFCI patients are performed by DFCI staff members. Any statements to the contrary in the Clinical Inpatient Services Agreement with Hospital #2 have been removed to accurately reflect DFCI’s independent role in handling all compliance and risk management tasks related to DFCI patients. 2. Communication/Education Infection Control Committee members were educated by the DFCI Senior Director of Patient Safety regarding the revised committee scope, and expanded metrics to be routinely reviewed, on October 14, 2016. Attendance was documented. Pharmacy & Therapeutics Committee members were educated by the DFCI Vice President of Pharmacy regarding the revised committee scope, and expanded metrics to be routinely reviewed, during a meeting on October 16, 2016. This education session was conducted in-person and via webinar, and attendance was documented. The DFCI Chief Quality Officer reviewed the revised DFCI Patient Safety Dashboard in detail with QI/RM members on October 21, 2016. QI/RM Committee minutes reflect these activities and attendance was documented. See also the Communication/Education section in the response to Tag A273, which reflect the Institute’s QAPI-related efforts. 53 3. Monitoring of Compliance DFCI’s Quality and Patient Safety Department is maintaining the DFCI Quality Dashboard, ensuring that data are aggregated and reported per the defined schedule for each metric, and that reports are submitted to the QI Committee and QI/RM Committee for review. DFCI’s Quality and Patient Safety Department maintains the DFCI Patient Safety Dashboard, ensures that the dashboard incorporates inpatient event data, and that reports are submitted quarterly to the QI/RM Committee for review. DFCI’s Pharmacy Department ensures that the Pharmacy & Therapeutics Committee meets per the defined schedule, records meeting minutes and reports annually to the QI/RM Committee. DFCI’s Quality and Patient Safety Department ensures the Infection Control Committee meets per the defined schedule, records meeting minutes and reports annually to the QI/RM Committee. The POC-specific monitoring described above will be conducted on a quarterly basis for the longer of one (1) year or until Substantial Compliance is achieved for four (4) consecutive quarters. Results of the monitoring are reported quarterly to the Executive POC Committee, and to the QI Committee and the QI/RM Committee as part of the QAPI Plan. At a minimum, such quarterly reports will be made on April 28, 2017, July 27, 2017, October 27, 2017 and December, 8 2017 to the Board of Trustees QI/RM Committee. Any identified instances of noncompliance are immediately reported to the DFCI Chief Quality Officer, who will ensure there is prompt remedial action. 4. QAPI This POC is identified as a QAPI Plan priority, and progress toward commitments set forth in the POC is being monitored through the QAPI program. For each action in the POC, DFCI has identified the following reporting structure: (i) reporting to the Executive POC Committee to ensure coordinated leadership oversight and accountability for sustained compliance with all POC commitments, and (ii) reporting to committees of the Board of Trustees to ensure governing body oversight. Overall progress on the POC is monitored by the QI Committee and the QI/RM Committee in their respective roles in overseeing QAPI function. See Attachment A043-01: POC Governing Body Reporting Figure and Attachment A263-02: QAPI POC Projects. To date, reports on POC progress have been presented to the QI Committee on February 2, 2017 and February 28, 2017, and to the QI/RM Committee on December 9, 2016 and February 3, 2017. In addition, an update was provided to the Board of Trustees on January 30, 2017. 5. Responsible Leader DFCI Chief Quality Officer 54 Tag A308 QAPI Governing Body Completion Date – December 31, 2016 1. Corrective Action DFCI is committed to ensuring that its QAPI program assesses all services, including those provided under contract, identifies quality and performance problems, implements appropriate corrective or improvement activities and ensures the monitoring and sustainability of those corrective or improvement activities. The QAPI Plan outlines how projects are identified and prioritized for improvement activities. Prior to August 2016, improvement projects were generally identified, prioritized and implemented across the oncology service line in an integrated and coordinated manner with Hospital #2. However, as identified in this POC and in the QAPI Plan, DFCI now independently identifies and prioritizes improvement projects in the DFCI inpatient hospital and monitors implementation. Further, for FY 2017, DFCI has identified this POC as a key quality improvement priority for the hospital. As such, detailed quality improvement project documentation has been created for each monitoring component of the Plan of Correction. See Attachment A263-02: QAPI POC Projects. DFCI completed a thorough reassessment of services purchased under arrangement for the inpatient hospital (contracted services) in November of 2016. By December 31, 2016, and as described in more detail in Tag A083, DFCI executed a series of new contracted services agreements. The DFCI Executive Sponsors, QI Committee, and the QI/RM Committee receive regular reports regarding each contracted service, the assessment of quality indicators associated with the services, and on any related performance improvement plans. The detailed process for overseeing all contracted services was approved by the QI/RM on December 9, 2016. 2. Communication/Education On October 24, 2016, the General Counsel/Chief Governance Officer and special counsel provided in-person refresher education to the Board of Trustees regarding its critical role in and responsibility for independently evaluating and overseeing the quality, safety, and performance of contracted services. Beginning on November 8, 2016, DFCI Executive Sponsors educated all DFCI Service Owners regarding their responsibilities in monitoring compliance with contracted services requirements, evaluating quality and performance indicators and reports for the contracted services, monitoring performance improvement programs and corrective action plans for deficient contracted services and escalating any performance concerns to the DFCI Executive Sponsor and QI Committee. These education efforts focused on reviewing processes to ensure compliance with the commitments set forth here and in Tag A083. Additional education was provided at a general management meeting on December 15, 2016, with follow-up through email communications for personnel unable to attend this meeting. 56 3. Monitoring of Compliance In coordination with DFCI’s Quality and Patient Safety Department, the Director of Hospital Administration ensures that the Service Owners are collecting, evaluating and appropriately reporting the data to monitor ongoing performance of contracted services. DFCI’s Chief Operating Officer or her designee monitors the ongoing assessment of all contracted services and associated reporting to DFCI Executive Sponsors to ensure continued compliance with respect to this aspect of the Plan of Correction. This POC-specific monitoring is conducted on a quarterly basis for the longer of one (1) year or until Substantial Compliance is achieved for four (4) consecutive quarters. Results of the monitoring are reported quarterly to the Executive POC Committee and to the QI/RM Committee. At a minimum, such quarterly reports will be made on April 28, 2017, July 27, 2017, October 27, 2017 and December 8, 2017 to the QI/RM Committee. Any identified instances of noncompliance are immediately reported to the Chief Operating Officer, who ensures there is prompt remedial action. After completion of this POC-specific monitoring, the QI/RM Committee will continue in its role of overseeing all contracted services. 4. QAPI This POC is identified as a QAPI Plan priority, and progress toward commitments set forth in the POC is being monitored through the QAPI program. For each action in the POC, DFCI has identified the following reporting structure: (i) reporting to the Executive POC Committee to ensure coordinated leadership oversight and accountability for sustained compliance with all POC commitments, and (ii) reporting to committees of the Board of Trustees to ensure governing body oversight. Overall progress on the POC is monitored by the QI Committee and the QI/RM Committee in their respective roles in overseeing QAPI function. See Attachment A043-01: POC Governing Body Reporting Figure and Attachment A263-02: QAPI POC Projects. To date, reports on POC progress have been presented to the QI Committee on February 2, 2017 and February 28, 2017, and to the QI/RM Committee on December 9, 2016 and February 3, 2017. In addition, an update was provided to the Board of Trustees on January 30, 2017. 5. Responsible Leader DFCI Chief Operating Officer 57 Tag A309 QAPI Executive Responsibilities Completion Date – November 15, 2016 1. Corrective Action DFCI’s Board of Trustees, medical staff, and administrative leaders are committed to ensuring responsible, accountable and independent oversight of an ongoing program for quality improvement and patient safety; hospital-wide quality assessment and performance improvement efforts that effectively address priorities for quality and safety; and an appropriate number of performance improvement projects conducted annually. DFCI’s independent written QAPI Plan was revised in October 2016 and again in December 2016, with the current version approved by the QI/RM Committee on December 9, 2016. Revisions reinforce that DFCI establishes independent priorities to improve quality of care and patient safety. The December QAPI Plan revision clearly designates this Plan of Correction as a key performance improvement priority for FY2017. Progress toward achieving this Plan of Correction, including the dates indicated herein, has been integrated into the DFCI QAPI program. See Attachment A263-01: QAPI Plan. Performance improvement in inpatient nursing quality at DFCI is included in the QAPI Plan, and improvement activities are guided by these quality metrics which were approved by the QI/RM Committee. DFCI has assumed responsibility for independently collecting, analyzing, presenting and monitoring data and quality indicators reflecting performance in nursing in the DFCI inpatient hospital. These data were first integrated into the DFCI Quality Dashboard on November 15, 2016. Nurse-sensitive quality metrics are reviewed by the DFCI Nursing Executive Committee for Quality (NECQ). NECQ is an established DFCI committee charged with review of measures of the quality of nursing care at DFCI, and recommending and contributing to nursing improvement projects, and as of October 26, 2016, reports to the QI Committee. The NECQ charter was revised to indicate this reporting relationship and to specify the committee’s responsibility for reviewing measures of nursing quality in the DFCI inpatient hospital. In accordance with the QAPI Plan, these inpatient nurse-sensitive quality metrics include: fall rates; hospital acquired pressure ulcers (HAPU); central line-associated blood stream infections (CLASBI); catheter associated urinary tract infections (CAUTI); chemotherapy extravasations; blood transfusion documentation compliance; pain assessment documentation compliance; pain education on pain medication; and patient satisfaction. The NECQ assists in establishing DFCI target goals for each metric. NECQ provides the forum for discussion, analysis and planning of Department of Nursing quality improvement initiatives for any indicators not meeting target goals. The NECQ monthly agendas focus on priorities and progress toward target goals for nursingsensitive quality metrics. On October 18, 2016, NECQ’s agenda focused on reviewing measures related to initial nursing assessment and pain education documentation for the DFCI inpatient hospital. Areas not meeting target goals were identified and nurse leaders were asked to report back to NECQ on any actions taken and progress made to improve performance. At the November 15, 2016 NECQ meeting, nurse leaders reported on actions taken. These 59 actions included reeducation of nursing staff and clarification of required documentation fields. Since target goals were not achieved, improvement of documentation compliance continues to be a focus of the NECQ. For all approved performance metrics, the QI Committee has assumed responsibility for ongoing monitoring of performance of the DFCI Quality Dashboard. The DFCI Quality Dashboard was first populated with data on November 15, 2016, and will be updated and presented to the QI Committee at each of its meetings after this date. The QI Committee meets eight times per year, at minimum. When trends are noted, the QI Committee determines needs for performance improvement, establishes performance improvement plans, and monitors implementation and results of such improvement plans. The QI Committee collaborates with other committees to perform these functions. See Attachment A263-01: QAPI Plan – Appendix for the QI Committee organization structure. The QI Committee works with DFCI managers, and additional staff and stakeholders, to conduct performance improvement activities. Quality and Patient Safety Department staff provide quality and process improvement expertise to support performance improvement activities. The performance improvement activities described herein apply to ambulatory and inpatient care settings. Quality data and progress on performance improvement activities is reported to the QI/RM Committee at least quarterly. The QI/RM Committee reports quarterly to the Board of Trustees. 2. Communication/Education The revised DFCI Quality Dashboard was reviewed and approved by the QI/RM Committee on October 21, 2016, and the revised QAPI Plan was approved by QI/RM on December 9, 2016. See Attachment A263-01: QAPI Plan which includes the approved DFCI Quality Dashboard metrics as an appendix. QI/RM Committee minutes reflect these activities and attendance was documented. DFCI’s Quality and Patient Safety Department oriented DFCI staff managers representing all applicable disciplines and departments within DFCI regarding the revised QAPI Plan through email communication on October 31, 2016; written acknowledgement of receipt and understanding was obtained from all recipients. On October 26, 2016, members of the QI Committee attended an orientation and education session run by the Quality and Patient Safety Department which included review of the QI Committee charter, the DFCI Quality Dashboard, and the QAPI Plan. The orientation and education session was mandatory and attendance was documented. See Tag A273 for additional detail. 3. Monitoring of Compliance DFCI’s Quality and Patient Safety Department maintains the DFCI Quality Dashboard, ensures that data are aggregated and reported per the defined schedule for each metric, and that results are reported to the QI Committee and to the QI/RM Committee consistent with this POC. The Chief Nursing Officer and Chief Quality Officer ensure efficient and independent collection of DFCI inpatient nursing quality data. DFCI’s Quality and Patient Safety Department ensures that the QI Committee meets per the defined schedule and records meeting minutes. The POC-specific monitoring described above will be conducted on a quarterly basis for the longer of one (1) year or until Substantial Compliance is achieved for four (4) consecutive quarters. Results of the monitoring are reported quarterly to the Executive POC Committee, and to the QI Committee and the QI/RM Committee as part of the QAPI Plan. At a minimum, such 60 quarterly reports will be made on April 28, 2017, July 27, 2017, October 27, 2017 and December 8, 2017 to the QI/RM Committee. Any identified instances of noncompliance are immediately reported to the DFCI Chief Quality Officer, who will ensure there is prompt remedial action. 4. QAPI This POC is identified as a QAPI Plan priority, and progress toward commitments set forth in the POC is being monitored through the QAPI program. For each action in the POC, DFCI has identified the following reporting structure: (i) reporting to the Executive POC Committee to ensure coordinated leadership oversight and accountability for sustained compliance with all POC commitments, and (ii) reporting to committees of the Board of Trustees to ensure governing body oversight. Overall progress on the POC is monitored by the QI Committee and the QI/RM Committee in their respective roles in overseeing QAPI function. See Attachment A043-01: POC Governing Body Reporting Figure and Attachment A263-02: QAPI POC Projects. To date, reports on POC progress have been presented to the QI Committee on February 2, 2017 and February 28, 2017, and to the QI/RM Committee on December 9, 2016 and February 3, 2017. In addition, an update was provided to the Board of Trustees on January 30, 2017. 5. Responsible Leader DFCI Chief Quality Officer, assisted by the DFCI Chief Nursing Officer 61 NEW Tag A315 Providing Adequate Resources Completion Date – November 15, 2016 1. Corrective Action DFCI is committed to providing adequate resources to ensure that DFCI fully satisfies its obligations for quality assurance and improvement activities in all clinical areas. As described below, DFCI has dedicated appropriate resources to measure, assess, improve and sustain DFCI inpatient performance with the goal of reducing risk to patients. For purposes of clarification in relation to the findings cited under this Tag, all DFCI inpatient events reported to the hospital event reporting system are and will continue to be reviewed by DFCI safety and risk management staff. Investigations and/or root cause analyses related to these events are performed by DFCI safety and risk management staff. DFCI ensures that data are collected, analyzed, and measured directly by DFCI. DFCI has defined and implemented performance measures; is conducting ongoing performance monitoring; has defined performance improvement priorities; and is monitoring improvement. DFCI is ensuring direct access to the performance data for the inpatient hospital, through steps such as the development of electronic health record reports for the DFCI inpatient hospital and the creation of DFCI-led audit programs. DFCI has committed new, dedicated resources to ensure that the hospital is successful in meeting these commitments. To ensure compliance with this standard, DFCI has: Established the QI Committee (see Tag A273). As of September 23, 2016, revised the job descriptions for the following Quality and Patient Safety Department staff to specify responsibility for quality and safety of DFCI inpatient services: Medical Director for Patient Safety and Risk Management; Senior Director, Patient Safety; Risk Manager. See Attachment A263-08: Revised & Approved Job Descriptions. Expanded the scope of the DFCI Pharmacy & Therapeutics Committee. See Attachment A263-06 DFCI Pharmacy and Therapeutics Committee Policy, A263-07 DFCI Pharmacy and Therapeutics Committee Roster where the expanded committee scope is described. Committed additional staffing to oversee quality data collection, aggregation, and reporting for DFCI inpatient care. As described in the response to Tag A273, DFCI has identified performance measures for DFCI inpatient care, and is collecting, analyzing, presenting, and monitoring these performance measures. A new program manager position has been hired to ensure that adequate resources and expertise are dedicated to data collection, aggregation, and improvement initiatives. As described in the response to Tag A286, consistent with longstanding practice, DFCI will continue to review all safety events and conduct investigations and root cause analyses for DFCI inpatients. 2. Communication/Education 63 A new program manager dedicated to managing DFCI inpatient care quality initiatives was hired and oriented to his position on November 15, 2016. All Quality and Patient Safety Department staff members with expanded job descriptions received individualized in-person education on September 27, 2016 from the Chief Quality Officer to ensure that roles and responsibilities are understood. Minutes from these education sessions were prepared and all affected staff were present. See responses to Tags A273 and A286 for additional information on communication and education efforts. 3. Monitoring of Compliance The Quality and Patient Safety Department has ensured that all appropriate job descriptions were revised, and staff were trained regarding the changes to QAPI program. The Quality and Patient Safety Department will orient new staff resources upon hire, and ensure that the QI Committee meets per the defined schedule and records meeting minutes. DFCI’s Pharmacy Department will ensure that the Pharmacy & Therapeutics Committee meets per the defined schedule and records meeting minutes. The POC-specific monitoring described above will be conducted on a quarterly basis for the longer of one (1) year or until Substantial Compliance is achieved for four (4) consecutive quarters. Results of the monitoring are reported quarterly to the Executive POC Committee, and to the QI Committee and the QI/RM Committee as part of the QAPI Plan. At a minimum, such quarterly reports will be made on April 28, 2017, July 27, 2017, October 27, 2017 and December 8, 2017 to the QI/RM Committee. Any identified instances of noncompliance are immediately reported to the DFCI Chief Quality Officer, who will ensure there is prompt remedial action. 4. QAPI This POC is identified as a QAPI Plan priority, and progress toward commitments set forth in the POC is being monitored through the QAPI program. For each action in the POC, DFCI has identified the following reporting structure: (i) reporting to the Executive POC Committee to ensure coordinated leadership oversight and accountability for sustained compliance with all POC commitments, and (ii) reporting to committees of the Board of Trustees to ensure governing body oversight. Overall progress on the POC is monitored by the QI Committee and the QI/RM Committee in their respective roles in overseeing QAPI function. See Attachment A043-01: POC Governing Body Reporting Figure and Attachment A263-02: QAPI POC Projects. To date, reports on POC progress have been presented to the QI Committee on February 2, 2017 and February 28, 2017, and to the QI/RM Committee on December 9, 2016 and February 3, 2017. In addition, an update was provided to the Board of Trustees on January 30, 2017. 5. Responsible Leader DFCI Chief Quality Officer 64 42 CFR 482.22 Medical Staff 65 mar Tag A338 Medical Staff Completion Date – March 31, 2017 1. Corrective Action The organized medical staff of Dana-Farber Cancer Institute (DFCI or the Institute) is committed to operating under bylaws approved by the Board of Trustees, and to ensuring the quality and safety of medical care provided to DFCI patients. Additionally, DFCI’s medical staff and its governing body are committed to ensuring that the DFCI Medical Staff Bylaws (Bylaws) apply equally to all staff as relates to credentialing (which includes appointments to the medical staff and privileging). To ensure continued compliance with this Medical Staff Condition, DFCI has revised the Bylaws to reflect the implementation of an independent credentialing process applicable to all members of the medical staff, as described in the response to Tag A341. As of October 24, 2016, DFCI ceased utilizing the joint credentialing process described in the previous version of the Bylaws and the related medical staff policy titled, “Dana-Farber Cancer Institute (DFCI) and Brigham and Women’s Hospital (BWH) Joint Credentialing Process,” to align with the amended Bylaws, and to implement the independent credentialing process described in this Tag A338 and Tag A341. See Attachment A338-01: Medical Staff Bylaws. Amendments to the Bylaws reflecting the change in the credentialing process were reviewed and approved by the DFCI Medical Staff Executive Committee at its meeting on September 19, 2016, and the DFCI medical staff at its meeting on October 19, 2016; all pursuant to Article 10, Sections 2 and 3 of the Bylaws. The DFCI Board of Trustees subsequently reviewed and approved the amendments, as required by Article 10, Section 4 of the Bylaws, at its meeting on October 24, 2016. The Bylaws were approved with an effective date of November 23, 2016; the date by which DFCI anticipated the last remaining joint credentialed physicians would have their credentials approved by the Board. However, during October and November, DFCI significantly expanded its efforts to independently credential all previously joint credentialed physicians, such that the last group of joint credentialed physicians received Board approval on October 24, 2016. From this date forward, all physicians applying for credentialing or recredentialing at DFCI have been or will be reviewed through a fully independent process as described in more detail in Tag A341. Therefore, for purposes of this POC, the implementation date for DFCI’s independent credentialing process began as of October 24, 2016. 2. Communication/Education All DFCI medical staff members were informed by DFCI’s Chief Medical Officer of the anticipated changes to the Bylaws by email on September 29, 2016. All DFCI Department Chairs were notified by DFCI’s Chief Medical Officer again by separate email on September 30, 2016. Further, the proposed changes to the Bylaws and associated credentialing processes were presented by the President of the Medical Staff at the DFCI annual medical staff meeting on October 19, 2016; which was followed by a vote of approval by the voting medical staff members. The Executive Committee of the Board of Trustees was informed by the Chief Governance Officer of the proposed Bylaws changes at its meeting on September 29, 2016, and the Board of Trustees approved these changes at its meeting on October 24, 2016 to take effect on November 23, 2016, the date by which DFCI anticipated the last remaining joint credentialed physicians would have their credentials approved by the Board. The Chair of the 67 Medical Staff Credentials Committee informed the Credentials Committee of the anticipated Bylaws changes on October 11, 2016, and again informed the Credentials Committee of the approved changes on November 8, 2016. As early as August 9, 2016, DFCI’s Office of Medical Affairs and Professional Credentialing (OMAPC) staff have been deeply involved in discussions and planning regarding updating DFCI’s credentialing process, and in executing the resulting expanded credentialing activities. However, to ensure that the OMAPC staff were formally aware of the revisions to the Bylaws, the changes in credentialing practices, and to answer any remaining questions, on November 10, 2016, DFCI’s Chief of Staff met with all members of DFCI’s OMAPC staff for this purpose. Attendance was documented at all in-person meetings where the Bylaws changes were presented. 3. Monitoring of Compliance DFCI’s OMAPC prepares monthly reports to document DFCI’s progress toward meeting the credentialing commitments set forth in this POC. The monthly reports will continue to be prepared until all previously joint credentialed staff have completed credentialing through the independent process described herein and in the amended Bylaws. These monthly reports are described in greater detail in Tag A341. Starting on March 31, 2017 (the date the corrective actions described herein are expected to be complete), DFCI’s OMAPC will continue to monitor, on a quarterly basis, DFCI’s credentialing process to ensure that DFCI medical staff applicants are being credentialed in a manner consistent with the amended Bylaws. Specifically, DFCI’s OMAPC will select a random sample of ten (10) DFCI-credentialed physicians whose applications were reviewed during the prior three (3) month period to verify that DFCI is following the credentialing process described in the amended Bylaws. This POC-specific quarterly monitoring will continue for the longer of one (1) year or until “Substantial Compliance” is achieved for four (4) consecutive quarters. “Substantial Compliance,” as defined throughout this POC, means a collective 90% compliance for those indicators monitored in any given Tag. Results of the monitoring will be reported quarterly to the Medical Staff Executive Committee, to the Executive POC Committee and to the Executive Committee of the Board of Trustees. At a minimum, such quarterly reports will be made on March 31, 2017, June 29, 2017, September 29, 2017, and December 1, 2017. Any identified instances of noncompliance will be immediately reported to the DFCI Chief Medical Officer, who will ensure there is prompt remedial action. 4. QAPI This POC is identified as a QAPI Plan priority, and progress toward commitments set forth in the POC is being monitored through the QAPI program. For each action in the POC, DFCI has identified the following reporting structure: (i) reporting to the Executive POC Committee to ensure coordinated leadership oversight and accountability for sustained compliance with all POC commitments, and (ii) reporting to committees of the Board of Trustees to ensure governing body oversight. Overall progress on the POC is monitored by the QI Committee and the QI/RM Committee in their respective roles in overseeing QAPI function. See Attachment A043-01: POC Governing Body Reporting Figure and Attachment A263-02: QAPI POC Projects. To date, reports on POC progress have been presented to the QI Committee on 68 February 2, 2017 and February 28, 2017, and to the QI/RM Committee on December 9, 2016 and February 3, 2017. In addition, an update was provided to the Board of Trustees on January 30, 2017. 5. Responsible Leader DFCI Chief Medical Officer 69 mum Tag A341 Medical Staff Credentialing Completion Date – March 31, 2017 1. Corrective Action DFCI’s Chief Medical Officer and medical staff are committed to: (i) independently examining the credentials of all eligible candidates for medical staff membership; (ii) making recommendations to the Board of Trustees on the appointment of candidates in accordance with all applicable laws and regulations, including scope of practice laws, the Bylaws, and the medical staff rules and regulations; (iii) ensuring that such candidates who are appointed by the Board of Trustees are subject to the Bylaws and the medical staff rules and regulations; and (iv) maintaining a consistent, separate and independent credentialing process that applies equally to all medical staff members and applicants. Independent Credentialing Process To ensure continued compliance with this Standard, the Bylaws have been amended to reflect an independent credentialing process, as described in the response to Tag A338. As of October 24, 2016, DFCI ceased utilizing the joint credentialing process described in the previous version of the Bylaws and the related medical staff policy titled, “Dana-Farber Cancer Institute (DFCI) and Brigham and Women’s Hospital (BWH) Joint Credentialing Process,” to align with the amended Bylaws, and to implement the independent credentialing process described in this Tag A341. See Attachment A338-01: Medical Staff Bylaws. As described in Tag A338, the last cohort of joint credentialed physicians had their credentials approved by the Board on October 24, 2016, and from this date forward, all medical staff members applying for appointment or reappointment to the DFCI medical staff and for clinical privileges are being, and will continue to be, evaluated through a consistent, separate and independent credentialing process. All application materials, including for physicians the Massachusetts Integrated Application for Initial Credentialing and Massachusetts Integrated Application for Re-Credentialing, are being reviewed by DFCI with no reliance on, overlap with or joint processes shared with any other hospital. DFCI is performing all primary source verification and is processing all requests for clinical privileges for candidates seeking DFCI credentials. In order to meet the commitments in the above paragraph, DFCI has taken, and will continue to take, significant steps to fully credential the approximately 1,200 physicians who were previously credentialed by DFCI pursuant to a Massachusetts Board of Registration in Medicine-approved joint credentialing process. DFCI explored the possibility of engaging a thirdparty credentials verification organization (CVO) to assist with this process; however, no CVO could be identified that had the capability or capacity to take on a project of this scope. Accordingly, DFCI has expanded its OMAPC through hiring three (3) additional, permanent staff and contracting for at least four (4) temporary staff, to distribute, evaluate and process the applications for this group of approximately 1,200 physicians. Additional permanent staff positions within DFCI’s OMAPC have been posted, but have not yet been filled. 71 As of January 4, 2017, all applications were distributed to the pool of approximately 1,200 physicians (311 in October 2016; 276 in November 2016; 417 in December 2016; 113 in January 2017). A summary is shown in the table below. In order to process and review a total of approximately 1,200 credentialing applications, the DFCI Medical Staff Credentials Committee, Medical Staff Executive Committee and Board of Trustees (or authorized Board committee) did and/or will schedule additional meetings or extend existing meetings from December 2016 – March 2017 to address the increased volume of applications. To meet the March 31, 2017 timeline for review of all previously joint credentialed applicants, DFCI has completed committee and Board reviews of approximately 860 applications as of February 23, 2016, and anticipates completion of all outstanding applications in March 2017. Table: Summary of DFCI Credentialing Application Distribution and Review Schedule Current as of 3/2/2017 Measure Oct-16 Nov-16 Dec-16 Jan-17 Feb-17 Mar-17 Total Applications distributed to consulting physicians for completion1 311 276 417 113 -- Applications returned to DFCI for evaluation2 141 231 112 198 371 1053 Requests for termination from the DFCI medical staff 52 21 47 85 205 Applications processed by the Office of Medical Affairs and Professional Credentialing and ready for committee review 65 149 143 298 655 Applications successfully reviewed by Credentials Committee, Medical Staff Executive Committee and Board or Board Committee3 117 170 190 383 860 1000 830 640 257 257 Applications remaining to be reviewed 1117 Percent Complete (Goal 100% by 3/31/2017) 1 -- 1117 77% Includes applications identified for termination from the DFCI medical staff. 2 Efforts are underway to ensure DFCI’s Office of Medical Affairs and Professional Credentialing receives physician applications in a timely manner. 3 Includes terminations from the DFCI medical staff. 72 This extensive independent credentialing process is expected to be completed by March 31, 2017. Complete credentialing applications take approximately eight (8) weeks for OMAPC staff to evaluate and verify, and approximately three (3) weeks to proceed through the DFCI Medical Staff Credentials Committee, Medical Staff Executive Committee and Board of Trustees (or authorized Board committee) review and approval processes. To expedite the review process, distributed credentialing applications are requested to be returned to the OMAPC within two (2) weeks. After two (2) weeks, applicants who have not returned their applications receive an email reminder from the OMAPC with a copy to the applicant’s department administrator. If there is no response to the e-mail, the physician is contacted personally (by page) to ascertain their intention regarding credentialing and, if no resolution is obtained within one week, the matter is escalated to the applicant’s Department Chair and to the DFCI Chief Medical Officer for further follow-up. Once the application is returned, the OMAPC begins its review process. The OMAPC prioritized the credentialing of physicians to maximize the likelihood that any physician who may be called to consult or provide any service to a patient in the DFCI inpatient hospital would have already been credentialed by DFCI through the new independent credentialing process. If, by March 31, 2017, a physician has not been credentialed via the independent DFCI credentialing process, he or she will not be allowed to consult or provide any service to a patient in the DFCI inpatient hospital. Outpatient Locations – Urgent Transport Arrangements DFCI does not provide emergency services as such term is described in 42 CFR 482.12(f)(1) and 482.55. Consistent with 42 CFR 482.12 (f)(2), DFCI ensures that its clinical staff provide appropriate appraisals of emergencies that may occur in DFCI inpatient and outpatient hospital facilities, provide initial emergency treatment, and if necessary, refer patients experiencing a medical emergency to another hospital that is equipped and staffed to provide higher acuity care. On September 20, 2016, DFCI’s Cardio-Pulmonary Resuscitation (CPR) Manual was revised to reference that the appraisal of emergencies and initial emergency treatment (collectively, “Code Response”) is to be exclusively performed by DFCI clinical staff. Should a DFCI patient experience a code situation during their care at DFCI, DFCI-credentialed staff members and other non-credentialed allied staff will respond to provide such appraisal of the emergency and initial emergency treatment. However, if members of the DFCI medical team determine that such patient requires referral for specialized, emergent inpatient care at an acute care facility that is equipped and staffed to provide such care, they may call for an emergency medical transport team to expedite safe transport of the patient to a more appropriate inpatient clinical setting. Following receipt of the DPH’s October 21, 2016 letter, DFCI communicated in detail to DPH DFCI’s revised POC for this finding. On November 14, 2016, DFCI was informed that this aspect of the POC, which included DFCI’s intention to enter into urgent patient transport agreements with other acute care hospitals to facilitate the safe and prompt transport of such patients to these hospitals, was approved by DPH and CMS. See Attachment A341-02: DFCI DPH email communication November 14 2016. Immediately following this approval, DFCI pursued initiation and execution of such urgent patient transport agreements (each an “Urgent Transport Agreement”). See Attachments A341-03: DFCI-BCH 2016 Patient Transport 73 Agreement, A341-04: DFCI-SEMC 2016 Patient Transport Agreement and A083-05: DFCI Inpatient 2016 Patient Transport Agreement. Specifically, the prior agreement between DFCI and Hospital #3 entitled Code Team Responses was terminated and replaced with an Urgent Transport Agreement that more accurately describes the role of Hospital #3 in providing emergency medical response, similar to 9-1-1, for prompt and safe transport of DFCI pediatric outpatients receiving care at the DFCI location adjacent to Hospital #3 to Hospital #3 for care. Details of the process are as follows: If a patient experiences a code situation in the DFCI pediatric outpatient setting, DFCI-credentialed providers and other non-credentialed allied staff respond as the initial responders (i.e., Pedi-Code Blue Team) to provide appraisal and initial emergency treatment. The DFCI Pedi-Code Blue Team is a multidisciplinary team including physicians, nurses and respiratory therapists who are PALS (Pediatric Advanced Life Support) certified. This team is activated by emergency page and overhead announcement. If members of the DFCI medical team determine that the patient needs to be transferred to an urgent care setting for emergency services, they will call Hospital #3 to send a transport team to DFCI to assume care of the patient from the PediCode Blue Team and transport the patient to the appropriate Hospital #3 urgent care setting. In this regard, the Hospital #3 transport team acts as an emergency medical service. Once the transport team arrives on site, they assume care of and take full responsibility for and authority over the patient. Hospital #3 will be the hospital that assumes responsibility for, admits and cares for the patient. The members of the transport team are credentialed or otherwise evaluated and approved by Hospital #3, and the team includes nurses, physicians, emergency medical technicians and/or paramedics. The transport team provides this service on behalf of Hospital #3. DFCI executed a contract with Hospital #3 to define the scope of and terms for this service on December 30, 2016. See Attachment A341-03: DFCI-BCH 2016 Patient Transport Agreement. The transport team from Hospital #3 is able to respond immediately to DFCI requests for transport since Hospital #3 is located across the street from the DFCI. Of note, response time is logged and reviewed by the DFCI CPR Committee on a monthly basis during review of each transport event. Similarly, DFCI’s agreement with Hospital #4 entitled Code Team Services was terminated and replaced with an Urgent Transport Agreement that more accurately describes the role of Hospital #4 in providing emergency medical response, similar to 9-1-1, for prompt and safe transport of DFCI patients receiving care at the DFCI provider-based outpatient facility adjacent to Hospital #4 to Hospital #4 for care. As with the example described above with respect to DFCI’s pediatric outpatient setting, if a DFCI patient receiving care in DFCI’s provider-based outpatient facility adjacent to Hospital #4 experiences a code situation, the following will occur: 74 DFCI-credentialed providers and other non-credentialed allied staff already located within the provider-based outpatient facility will respond as the initial responders to provide appraisal and initial emergency treatment. If members of the DFCI medical team determine that the patient needs to be referred to an urgent care setting for emergency services, they will call Hospital #4 to send a transport team to DFCI to assume care of the patient and transport the patient to the appropriate Hospital #4 urgent care setting. In this regard, the Hospital #4 transport team acts as an emergency medical service. Once the transport team arrives on site, they take over care of and assume full responsibility for and authority over the patient. Hospital #4 will be the hospital that assumes responsibility for, admits and cares for the patient. The members of the transport team are credentialed or otherwise evaluated and approved by Hospital #4 and provide this service on behalf of Hospital #4. On December 16, 2016, DFCI executed a contract with Hospital #4 to define the scope of and terms for this service. See Attachment A341-04: DFCI-SEMC 2016 Patient Transport Agreement. DFCI believes this arrangement is optimal to ensure patient safety and quality of care for DFCI patients. The transport team from Hospital #4 is comprised of individuals with expertise in emergency and critical care, certified in Advanced Cardiac Life Support, and is able to respond immediately to DFCI requests for transport, since DFCI’s provider-based outpatient facility is located on the campus of Hospital #4. Further, given that Hospital #4 has exclusive knowledge of location and availability of beds to accommodate appropriate critical care, it is both most logical and safer for Hospital #4 to facilitate this urgent patient transport. Of note, response time is logged and reviewed by the CPR Committee on a monthly basis during review of each transport event. 2. Communication/Education Independent Credentialing Process As described in Tag A338, all DFCI medical staff members were informed by DFCI’s Chief Medical Officer of the revised credentialing practices and changes to the Bylaws by email on September 29, 2016. All DFCI Department Chairs were notified by DFCI’s Chief Medical Officer again by separate email on September 30, 2016. Further, the changes to the Bylaws and associated credentialing processes were presented by the President of the Medical Staff at the DFCI annual medical staff meeting on October 19, 2016; which was followed by a vote of approval by the voting medical staff members. The Executive Committee of the Board of Trustees was informed by the Chief Governance Officer of the revised credentialing practices and proposed Bylaws changes at its meeting on September 29, 2016, and the Board of Trustees approved these changes at its meeting on October 24, 2016. The Chair of the Medical Staff Credentials Committee informed the Credentials Committee of the revised credentialing practices and anticipated Bylaws changes on October 11, 2016, and again informed the Credentials Committee of the approved changes on November 8, 2016. As early as August 9, 2016, DFCI’s OMAPC staff have been deeply involved in discussions and planning regarding updating DFCI’s credentialing process, and in executing the resulting 75 expanded credentialing activities. However, to ensure that the OMAPC staff were formally aware of the revisions to the Bylaws, the changes in credentialing practices, and to answer any remaining questions, on November 10, 2016, DFCI’s Chief of Staff met with all members of DFCI’s OMAPC staff for this purpose. Attendance was documented at all in-person meetings where the Bylaws changes were presented or changes in credentialing practices were discussed. Outpatient Locations – Urgent Transport Arrangements In light of the November 14, 2016 DPH approval for this aspect of DFCI’s POC, DFCI’s Clinical Director of Pediatric Oncology and her designees completed the education and training of all appropriate administrative and clinical staff rendering care within DFCI’s pediatric outpatient program, and DFCI’s team of pediatric program code responders regarding the role of DFCI staff in code responses and the process for requesting transport pursuant to the Urgent Transport Agreement with Hospital #3. These education and training efforts were conducted using DFCI’s online training system, HealthStream. Participation was mandatory and tracked through HealthStream. The training was completed on January 23, 2017. Additionally, the DFCI’s Chief Medical Officer and Chief Nursing Officer conducted a meeting on January 23, 2017 with the Pediatric Oncology Department to review in-person the components of the online training. Similarly, given the November 14, 2016 approval for this aspect of DFCI’s POC, the Medical Director for DFCI’s provider-based outpatient facility adjacent to Hospital #4 and his designees educated and trained all appropriate administrative and clinical staff rendering care within this outpatient facility regarding the role of DFCI staff in code responses and the process for requesting transport pursuant to the Urgent Transport Agreement with Hospital #4. These education and training efforts were provided through in-person meetings. Attendance was mandatory and documented. Training was completed on December 22, 2016. 3. Monitoring of Compliance Independent Credentialing Process Starting in October, 2016, DFCI’s OMAPC has been preparing monthly reports to document DFCI’s progress toward meeting the credentialing commitments set forth in this POC. The monthly report include: the number of applications distributed to consulting physicians for completion, the number of applications completed and submitted to DFCI for evaluation, the number of applications processed and ready for review by the Medical Staff Credentials Committee, Medical Staff Executive Committee and Board of Trustees (or authorized Board committee), and the number of applications successfully reviewed and approved or rejected by the aforementioned committees. See Attachment A341-01: Credentialing and Privileging Monthly Report. Starting on December 15, 2016, this monthly report has been and will continue to be submitted to DFCI’s Executive POC Committee, Medical Staff Executive Committee, and Board of Trustees Executive Committee for purposes of monitoring compliance with this POC. Additionally, as requested in the October 21, 2016 letter from DPH, these reports have been submitted on December 30, 2016, January 31, 2017, and February 28, 2017 and will continue to be submitted on a monthly basis to DPH for review. See Attachment A341-01: Credentialing and Privileging Monthly Report. 76 Starting on March 31, 2017 (the date the corrective actions described herein are expected to be complete), DFCI’s OMAPC will continue to monitor, on a quarterly basis, DFCI’s credentialing and re-credentialing process to ensure that DFCI medical staff applicants are being credentialed in a manner consistent with the amended Bylaws. Specifically, DFCI’s OMAPC will select a random sample of ten (10) DFCI credentialed and/or re-credentialed physicians whose applications were reviewed during the prior three (3) month period to verify that DFCI is following the credentialing/re-credentialing process described in the amended Bylaws. This POC-specific quarterly monitoring will continue for the longer of one (1) year or until Substantial Compliance is achieved for four (4) consecutive quarters. Results of the monitoring will be reported quarterly to the Medical Staff Executive Committee, to the Executive POC Committee and to the Executive Committee of the Board of Trustees. At a minimum, such quarterly reports will be made on March 31, 2017, June 29, 2017, September 29, 2017, and December 1, 2017. Any identified instances of noncompliance will be immediately reported to the DFCI Chief Medical Officer, who will ensure there is prompt remedial action. Outpatient Locations – Urgent Transport Arrangements DFCI’s Chair of the CPR Committee will monitor on a quarterly basis to assess compliance with the updated policy and practices regarding the responsibility of DFCI staff and clinicians to respond to all codes in DFCI’s outpatient space, and, where necessary, to obtain urgent assistance with transport of patients who require a higher level of care by calling the appropriate Urgent Transport teams or by calling 9-1-1 Emergency Medical Services (EMS). This POCspecific monitoring will continue for the longer of one (1) year or until Substantial Compliance is achieved for four (4) consecutive quarters. Results of the monitoring will be reported quarterly to the Medical Staff Executive Committee, to the Executive POC Committee and to the Executive Committee of the Board of Trustees. At a minimum, such quarterly reports will be made on March 31, 2017, June 29, 2017, September 29, 2017, and December 1, 2017.Any identified instances of noncompliance will be immediately reported to the DFCI Chief Medical Officer, who will ensure there is prompt remedial action. 4. QAPI This POC is identified as a QAPI Plan priority, and progress toward commitments set forth in the POC is being monitored through the QAPI program. For each action in the POC, DFCI has identified the following reporting structure: (i) reporting to the Executive POC Committee to ensure coordinated leadership oversight and accountability for sustained compliance with all POC commitments, and (ii) reporting to committees of the Board of Trustees to ensure governing body oversight. Overall progress on the POC is monitored by the QI Committee and the QI/RM Committee in their respective roles in overseeing QAPI function. See Attachment A043-01: POC Governing Body Reporting Figure and Attachment A263-02: QAPI POC Projects. To date, reports on POC progress have been presented to the QI Committee on February 2, 2017 and February 28, 2017, and to the QI/RM Committee on December 9, 2016 and February 3, 2017. In addition, an update was provided to the Board of Trustees on January 30, 2017. 5. Responsible Leader DFCI Chief Medical Officer 77 42 CFR 482.23 Nursing Services 78 l-Em?cs Tag A385 Nursing Services Completion Date – January 4, 2017 1. Corrective Action Dana-Farber Cancer Institute (DFCI or the Institute) is committed to maintaining a separate and independent well-organized nursing service. As of January 4, 2017, DFCI has a separate and independent well-organized nursing service that provides 24-hour nursing services to its inpatients. As described in more detail in Tag A386, DFCI provides its inpatients an organized nursing service on the premises 24 hours a day, 7 days a week. See Attachment A385-01: Sample DFCI Inpatient Hospital Staffing Schedule. DFCI maintains 24-hour coverage in the DFCI inpatient hospital in four shifts: 7:00 am – 4:00 pm; 3:00 pm – 7:00 pm; 7:00 pm – 11:00 pm; and 11:00 pm – 7:00 am. DFCI’s separate and independent well-organized nursing service is under the direction of a DFCI-employed registered nurse, the Chief Nursing Officer (CNO). DFCI ensures that at least one registered nurse (RN) supervises the nursing service 24 hours a day, 7 days a week. DFCI also ensures an RN is on duty at all times. The DFCI organized nursing services are furnished to inpatients by the Institute, as described in Tag A386. In response to the Tag A385 findings, as of January 4, 2017, DFCI has completed the following actions: 1. As further described in Tag A386, DFCI has administrative nursing oversight over its inpatient hospital, including the determination of the types and numbers of nursing personnel and staff necessary to provide nursing care to patients. 2. As further described in Tag A394, all leased inpatient nurses2 meet DFCI licensing, education, and certification requirements. 3. As further described in Tags A398 and A409, all leased inpatient nurses adhere to DFCI policies and procedures. As further described Tag A398, DFCI-employed nursing leadership supervises and evaluates the clinical activities of each leased inpatient nurse. 4. As further described in Tag A409, DFCI established separate and independent policies to govern the use of blood products. 2. Communication and Education As of January 4, 2017, DFCI’s CNO (or her designee) trained and educated DFCI’s inpatient nurses on the separate and independent organized nursing service, including the Institute’s 24hour coverage of the inpatient hospital. Training and education of the identified individuals was conducted by the DFCI CNO (or her designee) in department in-person meetings, in one-on-one 2 The Nursing Services Condition of Participation (COP) regulation and the Form 2567 refers to such staff as “contract nursing staff” and/or “non-employee licensed nurses”. DFCI refers to such staff here as “leased inpatient nurses”. 80 in-person meetings, and/or via email communications (with read receipts, where appropriate). Attendance for in-person meetings was mandatory and participation was documented. Staff members who were unavailable for training sessions were required to complete training before returning to their positions. 3. Monitoring of Compliance To monitor compliance with the corrective actions described above, the DFCI CNO (or her designee) will: Evaluate the inpatient nurse staff schedule twice a month to ensure that inpatient nursing coverage is 24 hours a day, 7 days a week. This monitoring will continue for the longer of one (1) year or until Substantial Compliance is achieved for four (4) consecutive quarters. “Substantial Compliance,” as defined throughout this POC, means a collective 90% compliance for those indicators monitored in any given Tag. Results of the monitoring will be reported quarterly for one (1) year to the Executive POC Committee and the Board of Trustees Executive Committee. At a minimum, such quarterly reports will be made on March 31, 2017, June 29, 2017, September 29, 2017, and December 1, 2017. The DFCI CNO (or her designee) will promptly address any instances of noncompliance. 4. QAPI This Plan of Correction (POC) is identified as a QAPI Plan priority, and progress toward commitments set forth in the POC is being monitored through the QAPI program. For each action in the POC, DFCI has identified the following reporting structure: (i) reporting to the Executive POC Committee to ensure coordinated leadership oversight and accountability for sustained compliance with all POC commitments, and (ii) reporting to committees of the Board of Trustees to ensure governing body oversight. Overall progress on the POC is monitored by the QI Committee and the QI/RM Committee in their respective roles responsible for overseeing QAPI function. See Attachment A043-01: POC Governing Body Reporting Figure and Attachment A263-02: QAPI POC Projects. To date, reports on POC progress have been presented to the QI Committee on February 2, 2017 and February 28, 2017, and to the QI/RM Committee on December 9, 2016 and February 3, 2017. In addition, an update was provided to the Board of Trustees on January 30, 2017. 5. Responsible Leader DFCI CNO, assisted by DFCI Senior Vice President of Human Resources (SVP HR) 81 ma Tag A386 Organization of Nursing Services Completion date: January 4, 2017 1. Corrective Action As of January 4, 2017, DFCI has a separate and independent well-organized nursing service. DFCI has a plan of administrative authority and delineation of responsibility for patient care. Specifically, the DFCI inpatient hospital plan of administrative authority includes a director of the nursing service (i.e., the DFCI-employed CNO), a DFCI-employed VP of Nursing and Patient Care Services (VP), a DFCI-employed Inpatient Nursing Director (ND), a DFCI-employed Clinical Specialist (CS), Nurses-In-Charge, and staff nurses. See Attachment A386-01: DFCI Nursing Service Organizational Chart. The job descriptions for each of these positions delineate their patient care responsibilities with respect to the DFCI’s organized nursing service. See Attachment A386-02: DFCI Nursing Job Descriptions. Further, as required by the Nursing Services Condition of Participation (COP), the DFCI CNO is a licensed RN. The DFCI-employed CNO is responsible for the operation of the organized inpatient nursing service, including the types and numbers of nursing personnel and staff necessary to provide nursing care for all areas of the hospital. DFCI has a single nursing service hospital-wide and it is under the direction of one RN, the DFCI CNO. In addition to the employed inpatient nursing leadership, the DFCI CNO has determined that the inpatient hospital’s model of care currently requires 2.5 full-time equivalents (FTEs) Nurse in Charge positions and 50.9 FTE staff nurse positions (Permanent Inpatient Nurses). The DFCI CNO also requires that all of the inpatient nurses must be RNs. See Attachment A386-02: DFCI Nursing Job Descriptions. The DFCI CNO has also identified that to maintain the staffing levels necessary to meet the patients’ acuity needs, an additional supplemental pool of nurses must be available. Nurses in the supplemental pool occasionally work shifts in the DFCI inpatient hospital when a Permanent Inpatient Nurse is unavailable to cover his or her shift (Temporary Pool Nurses). Of note, once assigned to work a DFCI inpatient nursing shift, the assigned nurse provides care only to DFCI inpatients. The nurse does not move between licensed hospitals during his or her shift. The DFCI-employed ND evaluates the staffing plan to assure that the scheduled staff is sufficient to meet the clinical acuity of DFCI inpatients. Aided by an electronic tool, the DFCI ND measures inpatient acuity twice daily and nurse staffing is adjusted accordingly to ensure that the needs of DFCI’s inpatients are met, including “immediate availability” for bedside care of any inpatient. If the DFCI ND needs additional staff on any shift, a Temporary Pool Nurse is assigned for a full shift to the DFCI hospital. See Attachment A385-01: Sample DFCI Inpatient Hospital Staffing Schedule. Again, once assigned to work a DFCI inpatient nursing shift, the assigned nurse provides care only to DFCI inpatients. The nurse does not move between licensed hospitals during his or her shift. As of January 4, 2017, DFCI created a separate and independent nursing service governed by accepted policies and procedures. Those policies and procedures govern the operation of the nursing service including the scheduling of nursing personnel to provide patient care. 83 Specifically, as of January 4, 2017, DFCI established and completed training on separate and independent nursing policies and procedures that govern the care of patients in the inpatient hospital. The new policies and procedures are electronically available to all DFCI staff, including the inpatient nurses. The DFCI CNO was involved with, oversaw the development of and approved the nursing service staffing policies and procedures. As part of DFCI’s corrective actions, DFCI: 1. More clearly delineated the DFCI CNO’s responsibility to furnish and supervise all DFCI nursing services – both outpatient and inpatient on October 21, 2017 (See Attachment A386-01: DFCI Nursing Service Organizational Chart). 2. Hired the inpatient ND (an RN) on November 4, 2016 to hire, supervise and evaluate clinical activities of the nursing staff at the DFCI inpatient hospital. 3. Hired the inpatient CS (an RN) on February 21, 2017 to train, educate and assure the ongoing competence of the nursing staff in the DFCI Inpatient Hospital. 4. Modified the job description for the DFCI Vice President of Nursing and Clinical Services (VP) to include oversight of the inpatient hospital. See Attachment A386-02: DFCI Nursing Job Descriptions.3 5. Executed, on December 22, 2016, a Leased Employees Agreement between DFCI and Hospital #2 for the services of leased nursing staff to work in permanent and temporary positions in the DFCI inpatient hospital (the Permanent Inpatient and Temporary Pool Inpatient Nurses). See Attachment A083-04: DFCI Leased Employees Agreement. In other words, DFCI now employs the inpatient nursing leadership who are supplemented by leased inpatient nurses (the Permanent Inpatient and Temporary Pool Nurses). As permitted and contemplated under the Nursing Services COP, DFCI’s single organized nursing service is comprised of both employed nurses and leased inpatient nurses. DFCI’s inpatient hospital is supervised and directed by DFCI-employed nurses and staffed by leased nurses, who work under DFCI’s full direction and control. The leased DFCI inpatient nursing positions make up twelve percent (12%) of DFCI’s nursing staff positions. Significantly, the leased inpatient nurses in the inpatient hospital work only for one hospital during a given shift. These leased inpatient nurses are permanently assigned to DFCI and do not move between two licensed hospitals during the same shift. Further, the inpatient nurses are “immediately available” for bedside care of only DFCI inpatients. Finally, because DFCI controls all aspects of the work and performance, DFCI functions as the primary employer of the Permanent Inpatient Nurses. Hospital #2 acts as a secondary employer of the leased nurses – providing their paychecks and benefits. 3 The CNO is temporarily holding both positions (VP/CNO). 84 The newly executed Leased Employees Agreement now documents DFCI’s longstanding supervision, control, and direction over all aspects of the leased inpatient nurses in the inpatient hospital. Specifically: The leased inpatient nurses are subject to the oversight, direction, and control of the DFCI-employed CNO, VP, ND, and CS. (Attachment A083-04: DFCI Leased Employees Agreement, paragraph 1.1(d)). The leased inpatient nurses must follow DFCI policies and procedures, including nursing service patient care policies and procedures. (Id. at paragraphs 1.1(c) and 1.1(d)). DFCI separately and independently evaluates the leased inpatient nurses on an annual basis. (Id. at paragraph 1.1(d)). DFCI separately and independently trains and educates the leased inpatient nurses, including initial orientation, department-specific training, and other unit-based or Institute-wide training and education. (Id. at para. 1.1(k)). DFCI’s consent is required before any nurse is assigned to the leased inpatient hospital. (Id. at para. 1.1(e)). Hospital #2 is contractually obligated to cure any leased inpatient nurses’ failure to perform his or her job duties in a manner satisfactory to DFCI. (Id. at para. 1.1(f)(i)(2)). DFCI is able to remove any leased inpatient nurse from the inpatient hospital. (Id. at para. 1.1(f)(i)). DFCI separately and independently determines the required skill set and qualifications of the leased inpatient nurses. (Id. at para. 1.1(c)). See Attachment A083-04: DFCI Leased Employee Agreement. In response to the concerns raised in the Form 2567 with respect to IV/PICC line placement services, DFCI clarifies that it purchases IV/PICC line placement services under arrangement from Hospital #2. DFCI providers place the order for IV/PICC line placement for a given inpatient. The IV/PICC line placement team (which includes physician assistants (PAs) and nurses) responds to the order. While fulfilling an order, the team does not have other specific patient assignments at Hospital #2 and cannot be called away by Hospital #2. The nurses on this team are not part of DFCI’s organized nursing service. In addition, DFCI wishes to clarify that these purchased services are not chemotherapy infusion services. Rather, these are simply and solely IV/PICC line placement services. Patient transport DFCI inpatient staff initiate the first response to all medical emergencies within the DFCI inpatient hospital. DFCI does not provide emergency services as such term is described in 42 CFR §§ 482.12(f)(1) and 482.55. DFCI and its clinical staff provide appropriate appraisals of emergencies that may occur in DFCI inpatient and outpatient hospital facilities, provide initial emergency treatment, and if necessary, refer patients experiencing a medical emergency to another hospital that is equipped and staffed to provide higher acuity care. As described in Tag A341, DFCI has updated its policies and practices, to ensure that only DFCI clinicians provide 85 this appraisal, initial treatment and referral consistent with 42 CFR § 482.12(f)(2). Notably, “rapid response” is a separate clinical service provided by DFCI in DFCI’s inpatient hospital, distinct from emergency response activities described herein. Specifically, on September 20, 2016, DFCI’s Cardio-Pulmonary Resuscitation (CPR) Manual was revised to reference that the appraisal of emergencies and initial emergency treatment (collectively, Code Response) is to be exclusively performed by DFCI clinical staff. Should a DFCI patient experience a code situation during their care at DFCI, DFCI-credentialed staff members and other non-credentialed allied staff will respond to provide such appraisal of the emergency and initial emergency treatment. However, if members of the DFCI medical team determine that such patient requires referral for specialized, emergent inpatient care at an acute care facility that is equipped and staffed to provide such care, they may call for an emergency medical transport team to expedite safe transport of the patient to a more appropriate inpatient clinical setting. Following receipt of the DPH’s October 21, 2016 letter, DFCI communicated in detail to DPH DFCI’s revised POC for this finding. On November 14, 2016, DFCI was informed by DPH that this aspect of the POC, which included DFCI’s intention to enter into urgent patient transport agreements with other acute care hospitals to facilitate the safe and prompt transport of such patients to these hospitals, was approved by DPH and CMS. See Attachment A341-02: DFCI - DPH email communication November 14 2016. Immediately following this approval, DFCI pursued initiation and execution of urgent patient transport agreements (each an “Urgent Transport Agreement”). See Attachments A341-03: DFCI-BCH 2016 Patient Transport Agreement, A341-04: DFCI-SEMC 2016 Patient Transport Agreement and A083-05: DFCI Inpatient 2016 Patient Transport Agreement. As noted above, DFCI and Hospital #2 entered into a Patient Transport Agreement that clarifies the role of Hospital #2 in providing emergency medical response, similar to 9-1-1, for prompt and safe transport of DFCI inpatients to Hospital #2 for care. Details of the process are as follows: If a patient experiences a code situation in the DFCI inpatient hospital, DFCIcredentialed providers and other non-credentialed allied staff on the inpatient floor respond as the initial responders to provide appraisal and initial emergency treatment. If members of the DFCI medical team determine that the patient needs to be referred to an urgent care setting for emergency services, they will call Hospital #2 to send a transport team to DFCI to assume care of the patient and transport the patient to the appropriate Hospital #2 urgent care setting. In this regard, the Hospital #2 transport team acts as an emergency medical service. Once the transport team arrives on site, they assume care of and take full responsibility for and authority over the patient. Hospital #2 will be the hospital that assumes responsibility for, admits and cares for the patient. The members of the transport team are credentialed or otherwise evaluated and approved by Hospital #2, and the team includes clinicians and other individuals specific to the type of emergency situation, as detailed in the Patient Transfer Agreement. The transport team provides this service on behalf of Hospital #2. DFCI executed a contract with Hospital #2 to define the scope of and terms for this service on December 30, 2016. 86 The transport team from Hospital #2 is able to respond immediately to DFCI requests for transport since Hospital #2 is located across the street from DFCI. Of note, response time is logged and reviewed by the DFCI CPR Committee on a monthly basis during review of each transport event. With respect to DFCI’s provider-based outpatient facility located at Hospital #4, and as described in more detail in Tag A341, DFCI entered into an Urgent Transport Agreement with Hospital #4 that accurately describes the role of Hospital #4 in providing emergency medical response, similar to 9-1-1, for prompt and safe transport of DFCI patients receiving care at the DFCI location adjacent to Hospital #4 to Hospital #4 for care. 2. Communication and Education As of January 4, 2017, DFCI’s CNO (or her designee) trained and educated inpatient nursing leadership, leased inpatient nurses, Institute faculty and managers on the separate and independent organized inpatient nursing service. The training and education included, for example, DFCI’s plan of administrative authority, delineation of responsible for inpatient care, the nursing service patient care policies and procedures, and the new inpatient leadership structure (including employment of the inpatient nursing leadership). Training and education of the identified individuals was conducted by the DFCI CNO (or her designee) in department inperson meetings, in one-on-one in-person meetings, and/or via email communications (with read receipts, where appropriate). Attendance for in-person meetings was mandatory and participation was documented. Staff members who were unavailable for training sessions were required to complete training before returning to their positions. DFCI Inpatient Hospital – Patient Transport Arrangement In light of the November 14, 2016 DPH approval for the urgent transport aspect of DFCI’s POC, DFCI’s CNO and her designees completed the education and training of all appropriate nursing staff rendering care within DFCI’s inpatient hospital regarding the role of DFCI staff in code responses and the process for requesting urgent patient transport pursuant to the Patient Transport Agreement with Hospital #2. These education and training efforts were conducted at staff meetings, where attendance was mandatory. Additionally, the inpatient nursing staff were provided with instructional cards on the urgent patient transport process, for the inpatient nurses to attach to their identification badges. When distributing the cards to the inpatient nursing staff, the ND once more reviewed the code response and urgent patient transport process during brief one on one meetings with each inpatient nurse. Training activities were completed by January 23, 2017. Please see Tag A341 for additional details regarding communication and education activities with respect to DFCI’s provider-based outpatient facility located at Hospital #4. 3. Monitoring of Compliance: To monitor compliance with the corrective actions described above, the DFCI CNO (or her designee) will: Evaluate biweekly quality indicators, adverse events or near misses, pertinent patient satisfaction data, clinical and operational issues, and other matters related to assuring 87 the quality and safety of care provided to patients to ensure there is adequate inpatient nursing personnel to meet the needs of the inpatients. Evaluate monthly the utilization of Temporary Pool Nurses in the inpatient hospital to ensure there is adequate inpatient nursing personnel to meet the needs of the inpatients. DFCI’s clinical and quality staff will interview a sample of fifteen (15) inpatient clinical staff, including inpatient nurses, to evaluate such staff’s knowledge of the: (1) ability to locate the Institute’s inpatient hospital policies; and (2) substantive knowledge of the Institute’s inpatient hospital policies. This monitoring will continue for the longer of one (1) year or until Substantial Compliance is achieved for four (4) consecutive quarters. Results of the monitoring will be reported quarterly for one (1) year to the Executive POC Committee and the Board of Trustees Executive Committee. At a minimum, such quarterly reports will be made on March 31, 2017, June 29, 2017, September 29, 2017, and December 1, 2017. The DFCI CNO (or her designee) will promptly address any instances of non-compliance. DFCI Inpatient Hospital – Patient Transport Arrangement DFCI’s Chair of the CPR Committee will monitor on a quarterly basis to assess compliance with the updated policy and practices regarding the responsibility of DFCI staff and clinicians to respond to all codes in DFCI’s inpatient hospital, and, where necessary, to obtain urgent transport of patients who require a higher level of care by calling the appropriate urgent transport team or by calling 9-1-1 Emergency Medical Services (EMS). This POC-specific monitoring will continue for the longer of one (1) year or until Substantial Compliance is achieved for four (4) consecutive quarters. Results of the monitoring will be reported quarterly to the Medical Staff Executive Committee, to the Executive POC Committee and to the Executive Committee of the Board of Trustees. At a minimum, such quarterly reports will be made on March 31, 2017, June 29, 2017, September 29, 2017, and December 1, 2017. Any identified instances of noncompliance will be immediately reported to the DFCI Chief Medical Officer and CNO, who will ensure there is prompt remedial action. Please see Tag A341 for additional details regarding monitoring activities with respect to DFCI’s provider-based outpatient facility located at Hospital #4. 4. QAPI This POC is identified as a QAPI Plan priority, and progress toward commitments set forth in the POC is being monitored through the QAPI program. For each action in the POC, DFCI has identified the following reporting structure: (i) reporting to the Executive POC Committee to ensure coordinated leadership oversight and accountability for sustained compliance with all POC commitments, and (ii) reporting to committees of the Board of Trustees to ensure governing body oversight. Overall progress on the POC is monitored by the QI Committee and 88 the QI/RM Committee in their respective roles responsible for overseeing QAPI function. See Attachment A043-01: POC Governing Body Reporting Figure and Attachment A263-02: QAPI POC Projects. To date, reports on POC progress have been presented to the QI Committee on February 2, 2017 and February 28, 2017, and to the QI/RM Committee on December 9, 2016 and February 3, 2017. In addition, an update was provided to the Board of Trustees on January 30, 2017. 5. Responsible Leader: DFCI CNO 89 Tag A394 Licensure of Nursing Staff Completion date: January 4, 2017 1. Corrective Action As of January 4, 2017, DFCI’s organized nursing service now has a separate and independent procedure in place to ensure that inpatient hospital nursing personnel for whom current licensure is required, have a valid and current license. Specifically: DFCI revised its Human Resources Policy 2.06, Verification of License, Registration or Certification to require that DFCI’s Human Resources (HR) Department include all DFCI inpatient nurses in its primary source verification of professional licensure. See Attachment A394-01, Human Resources Policy 2.06, Verification of License, Registration or Certification. DFCI’s HR Department now conducts primary source verification for all DFCI inpatient nurses upon initial hire. DFCI’s HR Department maintains records on the DFCI inpatient nurses to monitor and document their compliance with certification and educational requirements. DFCI’s HR Department tracks professional licensure renewal for all DFCI inpatient nurses. DFCI’s Center for Clinical and Professional Development (CCPD) conducts ongoing licensure verification of all DFCI inpatient nurses on a biannual basis. The DFCI ND maintains separate licensure, certification and education records for all inpatient nurses. Pursuant to the Leased Employees Agreement, Hospital #2 may provide DFCI only with inpatient nurses who are licensed, certified and in good standing. DFCI HR identified the inpatient nursing personnel for whom current and valid licensure is required. DFCI HR developed a process to collect and maintain this information in a directory, which is updated on a monthly basis. DFCI prepared current job descriptions for all positions in the inpatient hospital to reflect licensure requirements. To meet the Nursing Services COP requirement that DFCI ensures that leased inpatient nurses meet all “licensing, educational and certification requirements”, the Institute completed the licensure and certification corrective action steps described above. In addition, with respect to education of the leased inpatient nurses, as of January 4, 2017, the Institute: Established required training and educational materials and competencies, including, for example – new employee orientation, Department-specific training, and annual online training. The courses encompass training and education on oncology nursing services patient care policies and procedures, including clinical practices, infection control, patient education, and blood transfusions. As of January 4, 2017, all leased inpatient nurses completed the assigned courses. 91 The DFCI Clinical Specialist now prepares, conducts, monitors, and assesses rolespecific competency modules for all leased inpatient nurses. Patient transport DFCI inpatient staff initiate the first response to all medical emergencies within the DFCI inpatient hospital. DFCI does not provide emergency services as such term is described in 42 CFR §§ 482.12(f)(1) and 482.55. DFCI and its clinical staff provide appropriate appraisals of emergencies that may occur in DFCI inpatient and outpatient hospital facilities, provide initial emergency treatment, and if necessary, refer patients experiencing a medical emergency to another hospital that is equipped and staffed to provide higher acuity care. DFCI has updated its policies, procedures and practices, to ensure that only DFCI clinicians provide this appraisal, initial treatment and referral consistent with 42 CFR § 482.12(f)(2). Notably, “rapid response” is a separate clinical service provided by DFCI in DFCI’s inpatient hospital, distinct from emergency response activities described herein. Specifically, on September 20, 2016, DFCI’s Cardio-Pulmonary Resuscitation (CPR) Manual was revised to reference that the appraisal of emergencies and initial emergency treatment (collectively, Code Response) is to be exclusively performed by DFCI clinical staff. Should a DFCI patient experience a code situation during their care at DFCI, DFCI-credentialed staff members and other non-credentialed allied staff will respond to provide such appraisal of the emergency and initial emergency treatment. However, if members of the DFCI medical team determine that such patient requires referral for specialized, emergent inpatient care at an acute care facility that is equipped and staffed to provide such care, they may call for an emergency medical transport team to expedite safe transport of the patient to a more appropriate inpatient clinical setting. Following receipt of the DPH’s October 21, 2016 letter, DFCI communicated in detail to DPH DFCI’s revised POC for this finding. On November 14, 2016, DFCI was informed by DPH that this aspect of the POC, which included DFCI’s intention to enter into urgent patient transport agreements with other acute care hospitals to facilitate the safe and prompt transport of such patients to these hospitals, was approved by DPH and CMS. See Attachment A341-02: DFCI - DPH email communication November 14 2016. Immediately following this approval, DFCI pursued initiation and execution of urgent patient transport agreements (each an “Urgent Transport Agreement”). See Attachments A341-03: DFCI-BCH 2016 Patient Transport Agreement, A341-04: DFCI-SEMC 2016 Patient Transport Agreement and A083-05: DFCI Inpatient 2016 Patient Transport Agreement. As noted above, DFCI and Hospital #2 entered into a Patient Transport Agreement that clarifies the role of Hospital #2 in providing emergency medical response, similar to 9-1-1, for prompt and safe transport of DFCI inpatients to Hospital #2 for care. Details of the process are as follows: If a patient experiences a code situation in the DFCI inpatient hospital, DFCIcredentialed providers and other non-credentialed allied staff on the inpatient floor respond as the initial responders to provide appraisal and initial emergency treatment. If members of the DFCI medical team determine that the patient needs to be referred to an urgent care setting for emergency services, they will call Hospital #2 to send a 92 transport team to DFCI to assume care of the patient and transport the patient to the appropriate Hospital #2 urgent care setting. In this regard, the Hospital #2 transport team acts as an emergency medical service. Once the transport team arrives on site, they assume care of and take full responsibility for and authority over the patient. Hospital #2 will be the hospital that assumes responsibility for, admits and cares for the patient. The members of the transport team are credentialed or otherwise evaluated and approved by Hospital #2, and the team includes clinicians and other individuals specific to the type of emergency situation, as detailed in the Patient Transfer Agreement. The transport team provides this service on behalf of Hospital #2. DFCI executed a contract with Hospital #2 to define the scope of and terms for this service on December 30, 2016. The transport team from Hospital #2 is able to respond immediately to DFCI requests for transport since Hospital #2 is located across the street from DFCI. Of note, response time is logged and reviewed by the DFCI CPR Committee on a monthly basis during review of each transport event. With respect to DFCI’s provider-based outpatient facility located at Hospital #4, and as described in Tag A341, DFCI entered into an Urgent Transport Agreement with Hospital #4 that accurately describes the role of Hospital #4 in providing emergency medical response, similar to 9-1-1, for prompt and safe transport of DFCI patients receiving care at the DFCI location adjacent to Hospital #4 to Hospital #4 for care. 2. Communication and Education As of January 4, 2017, the DFCI CNO (or her designee) communicated and educated the organized nursing service on the Institute’s new policy and procedures to separately and independently conduct primary source verification of professional licensure for all DFCI inpatient nurses. The DFCI CNO (or her designee) also communicated and educated the leased inpatient nurses on their new education, training and competency requirements. Training and education of the identified individuals was conducted by the DFCI CNO (or her designee) in department in-person meetings, in one-on-one in-person meetings, and/or via email communications (with read receipts, where appropriate). Attendance for in-person meetings was mandatory and participation was documented. Staff members who were unavailable for training sessions were required to complete training before returning to their positions. DFCI Inpatient Hospital – Patient Transport Arrangement In light of the November 14, 2016 DPH approval for the urgent transport aspect of DFCI’s POC, DFCI’s CNO and her designees completed the education and training of all appropriate nursing staff rendering care within DFCI’s inpatient hospital regarding the role of DFCI staff in code responses and the process for requesting urgent patient transport pursuant to the Patient Transport Agreement with Hospital #2. These education and training efforts were conducted at staff meetings, where attendance was mandatory. Additionally, the inpatient nursing staff were provided with instructional cards on the urgent patient transport process, for the inpatient nurses to attach to their identification badges. When distributing the cards to the inpatient nursing staff, 93 the ND once more reviewed the code response and urgent patient transport process during brief one on one meetings with each inpatient nurse. Training activities were completed by January 23, 2017. Please see Tag A341 for additional details regarding communication and education activities with respect to DFCI’s provider-based outpatient facility located at Hospital #4. 3. Monitoring of Compliance To monitor compliance with the corrective actions described above, the DFCI CNO (or her designee) will monthly: Review the personnel file of five (5) inpatient nurses to confirm: (a) his/her licensures is current, and (b) that DFCI HR’s Department or CCPD separately and independently verified the nurse’s licensure. This POC-specific monitoring will continue for the longer of one (1) year or until Substantial Compliance is achieved for four (4) consecutive quarters. Results of the monitoring will be reported quarterly for one (1) year to the Executive POC Committee and the Board of Trustees Executive Committee. At a minimum, such quarterly reports will be made on March 31, 2017, June 29, 2017, September 29, 2017, and December 1, 2017. DFCI CNO (or her designee) will promptly address any instances of non-compliance. DFCI Inpatient Hospital – Patient Transport Arrangement DFCI’s Chair of the CPR Committee will monitor on a quarterly basis to assess compliance with the updated policy and practices regarding the responsibility of DFCI staff and clinicians to respond to all codes in DFCI’s inpatient hospital, and, where necessary, to obtain urgent transport of patients who require a higher level of care by calling the appropriate urgent transport team or by calling 9-1-1 Emergency Medical Services (EMS). This POC-specific monitoring will continue for the longer of one (1) year or until Substantial Compliance is achieved for four (4) consecutive quarters. Results of the monitoring will be reported quarterly to the Medical Staff Executive Committee, to the Executive POC Committee and to the Executive Committee of the Board of Trustees. At a minimum, such quarterly reports will be made on March 31, 2017, June 29, 2017, September 29, 2017, and December 1, 2017. Any identified instances of noncompliance will be immediately reported to the DFCI Chief Medical Officer and CNO, who will ensure there is prompt remedial action. Please see Tag A341 for additional details regarding monitoring activities with respect to DFCI’s provider-based outpatient facility located at Hospital #4. 4. QAPI This POC is identified as a QAPI Plan priority, and progress toward commitments set forth in the POC is being monitored through the QAPI program. For each action in the POC, DFCI has identified the following reporting structure: (i) reporting to the Executive POC Committee to ensure coordinated leadership oversight and accountability for sustained compliance with all POC commitments, and (ii) reporting to committees of the Board of Trustees to ensure 94 governing body oversight. Overall progress on the POC is monitored by the QI Committee and the QI/RM Committee in their respective roles responsible for overseeing QAPI function. See Attachment A043-01: POC Governing Body Reporting Figure and Attachment A263-02: QAPI POC Projects. To date, reports on POC progress have been presented to the QI Committee on February 2, 2017 and February 28, 2017, and to the QI/RM Committee on December 9, 2016 and February 3, 2017. In addition, an update was provided to the Board of Trustees on January 30, 2017. 5. Responsible Leader DFCI CNO, with assistance from the SVP HR 95 mammary Tag A398 Supervision of Contract Staff Completion Date: January 4, 2017 1. Corrective Action As of January 4, 2017, DFCI’s leased inpatient nurses are required to adhere to the policies and procedures of the Institute. Specifically: 1. As of October 21, 2016, DFCI finalized separate and independent nursing policies and procedures governing the care of patients in the DFCI inpatient hospital. 2. On November 21, 2016, these policies were published and made available to all staff, including the leased inpatient nurses. 3. As of January 4, 2017, the leased inpatient nurses completed training on those policies and procedures. 4. The newly executed Leased Employees Agreement requires the leased inpatient nurses to follow DFCI policies and procedures, including nursing service patient care policies and procedures. See Attachment A083-04: DFCI Leased Employees Agreement. a. Hospital #2 is contractually obligated to cure any nurses’ failure to perform his or her job duties in a satisfaction manner, including a nurse’s failure to adhere to DFCI nursing policies, rules, and regulations related to nursing practice. b. DFCI is able to remove any leased inpatient nurse from the inpatient hospital, including for failing to adhere to DFCI nursing policies, rules, and regulations related to nursing practice. 5. On January 4, 2017, DFCI implemented a process to provide updates to all DFCI leased inpatient nurses on changes to nursing policies and procedures to ensure knowledge of Institute policy and procedure. 6. DFCI and the CNO are now responsible for ensuring that the leased inpatient nurses know DFCI’s policies and procedures in order for these nurses to adhere to those policies and procedures. 7. DFCI’s ND is now responsible for ensuring the leased inpatient nurses complete the training and orientation on DFCI’s policies and procedures. As of January 4, 2017, DFCI established a method for orienting the leased inpatient nurses to DFCI’s policies and procedures. All DFCI leased inpatient nurses are appropriately oriented prior to working in the inpatient hospital. Such nurses are oriented on: the hospital and their respective unit, emergency procedures, nursing services policies and procedures, and safety policies and procedures. Additionally, DFCI leased inpatient nurses are required to complete DFCI annual training which provides updated training on most of the above topics. As of January 4, 2017, the DFCI CNO is responsible for the supervision and evaluation of the clinical activities of the leased inpatient nurses. Significantly, only qualified DFCI-employed RNs (the DFCI CNO, VP, ND, and CS) supervise and evaluate the clinical activities of each leased 97 inpatient nurse. The DFCI-employed ND supervises the day-to-day activities of the leased inpatient nurses. As of January 4, 2017, the DFCI CNO now ensures the leased inpatient nurses receive a performance evaluation on an annual basis. As of January 4, 2017, DFCI maintains the performance reviews in the leased inpatient nurses’ personnel files. Evaluations for the Permanent Inpatient Nurses are incorporated into DFCI’s electronic performance review system. Shift performance evaluations of Temporary Pool Inpatient Nurses are prepared manually by the DFCI-employed ND. Patient transport DFCI inpatient staff initiate the first response to all medical emergencies within the DFCI inpatient hospital. DFCI does not provide emergency services as such term is described in 42 CFR §§ 482.12(f)(1) and 482.55. DFCI and its clinical staff provide appropriate appraisals of emergencies that may occur in DFCI inpatient and outpatient hospital facilities, provide initial emergency treatment, and if necessary, refer patients experiencing a medical emergency to another hospital that is equipped and staffed to provide higher acuity care. DFCI has updated its policies, procedures and practices, to ensure that only DFCI clinicians provide this appraisal, initial treatment and referral consistent with 42 CFR § 482.12(f)(2). Notably, “rapid response” is a separate clinical service provided by DFCI in DFCI’s inpatient hospital, distinct from emergency response activities described herein Specifically, on September 20, 2016, DFCI’s Cardio-Pulmonary Resuscitation (CPR) Manual was revised to reference that the appraisal of emergencies and initial emergency treatment (collectively, Code Response) is to be exclusively performed by DFCI clinical staff. Should a DFCI patient experience a code situation during their care at DFCI, DFCI-credentialed staff members and other non-credentialed allied staff will respond to provide such appraisal of the emergency and initial emergency treatment. However, if members of the DFCI medical team determine that such patient requires referral for specialized, emergent inpatient care at an acute care facility that is equipped and staffed to provide such care, they may call for an emergency medical transport team to expedite safe transport of the patient to a more appropriate inpatient clinical setting. Following receipt of the DPH’s October 21, 2016 letter, DFCI communicated in detail to DPH DFCI’s revised POC for this finding. On November 14, 2016, DFCI was informed by DPH that this aspect of the POC, which included DFCI’s intention to enter into urgent patient transport agreements with other acute care hospitals to facilitate the safe and prompt transport of such patients to these hospitals, was approved by DPH and CMS. See Attachment A341-02: DFCI - DPH email communication November 14 2016. Immediately following this approval, DFCI pursued initiation and execution of urgent patient transport agreements (each an “Urgent Transport Agreement”). See Attachments A341-03: DFCI-BCH 2016 Patient Transport Agreement, A341-04: DFCI-SEMC 2016 Patient Transport Agreement and A083-05: DFCI Inpatient 2016 Patient Transport Agreement. As noted above, DFCI and Hospital #2 entered into a Patient Transport Agreement that clarifies the role of Hospital #2 in providing emergency medical response, similar to 9-1-1, for prompt and safe transport of DFCI inpatients to Hospital #2 for care. Details of the process are as follows: 98 If a patient experiences a code situation in the DFCI inpatient hospital, DFCIcredentialed providers and other non-credentialed allied staff on the inpatient floor respond as the initial responders to provide appraisal and initial emergency treatment. If members of the DFCI medical team determine that the patient needs to be referred to an urgent care setting for emergency services, they will call Hospital #2 to send a transport team to DFCI to assume care of the patient and transport the patient to the appropriate Hospital #2 urgent care setting. In this regard, the Hospital #2 transport team acts as an emergency medical service. Once the transport team arrives on site, they assume care of and take full responsibility for and authority over the patient. Hospital #2 will be the hospital that assumes responsibility for, admits and cares for the patient. The members of the transport team are credentialed or otherwise evaluated and approved by Hospital #2, and the team includes clinicians and other individuals specific to the type of emergency situation, as detailed in the Patient Transfer Agreement. The transport team provides this service on behalf of Hospital #2. DFCI executed a contract with Hospital #2 to define the scope of and terms for this service on December 30, 2016. The transport team from Hospital #2 is able to respond immediately to DFCI requests for transport since Hospital #2 is located across the street from DFCI. Of note, response time is logged and reviewed by the DFCI CPR Committee on a monthly basis during review of each transport event. With respect to DFCI’s provider-based outpatient facility located at Hospital #4, and as described in greater detail in Tag 341, DFCI entered into an Urgent Transport Agreement with Hospital #4 that accurately describes the role of Hospital #4 in providing emergency medical response, similar to 9-1-1, for prompt and safe transport of DFCI patients receiving care at the DFCI location adjacent to Hospital #4 to Hospital #4 for care. 2. Communication and Education As of January 4, 2017, DFCI’s CNO (or her designee) communicated to and educated the organized nursing service that the leased inpatient nurses are obligated to follow Institute policies and procedures, the mechanism by which DFCI would update leased inpatient nurses about policy and procedure changes, the DFCI ND’s responsibility to ensure leased inpatient nurses complete training and orientation on Institute policies and procedures, that DFCIemployed inpatient nursing leadership supervise and evaluate the clinical activities of each leased inpatient nurse, and that performance evaluations of the leased inpatient nurses will be conducted by the Institute on an annual basis. Training and education of the identified individuals was conducted by the DFCI CNO (or her designee) in department in-person meetings, in one-on-one in-person meetings, and/or via email communications (with read receipts, where appropriate). Attendance for in-person meetings was mandatory and participation was documented. Staff members who were unavailable for training sessions were required to complete training before returning to their positions. DFCI Inpatient Hospital – Patient Transport Arrangement 99 In light of the November 14, 2016 DPH approval for the urgent transport aspect of DFCI’s POC, DFCI’s CNO and her designees completed the education and training of all appropriate nursing staff rendering care within DFCI’s inpatient hospital regarding the role of DFCI staff in code responses and the process for requesting urgent patient transport pursuant to the Patient Transport Agreement with Hospital #2. These education and training efforts were conducted at staff meetings, where attendance was mandatory. Additionally, the inpatient nursing staff were provided with instructional cards on the urgent patient transport process, for the inpatient nurses to attach to their identification badges. When distributing the cards to the inpatient nursing staff, the ND once more reviewed the code response and urgent patient transport process during brief one on one meetings with each inpatient nurse. Training activities were completed by January 23, 2017. Please see Tag A341 for additional details regarding communication and education activities with respect to DFCI’s provider-based outpatient facility located at Hospital #4. 3. Monitoring of Compliance To monitor compliance with the corrective actions described above, the DFCI CNO (or her designee) will: Interview five (5) leased inpatient nurses a month to evaluate: (a) their ability to locate DFCI’s policies and procedures and (b) their understanding that they are required to follow DFCI’s policies and procedures. Review on a monthly basis the personnel files of any new leased inpatient nurse to ensure that the nurse was appropriately oriented prior to working in the inpatient hospital. After the annual performance evaluations of leased inpatient nurses has been completed, review a sample of five (5) leased inpatient nurses to ensure their performance was evaluated by a DFCI employee. This POC-specific monitoring will continue for the longer of one (1) year or until Substantial Compliance is achieved for four (4) consecutive quarters. Results of the monitoring will be reported quarterly for one (1) year to the Executive POC Committee and the Board of Trustees Executive Committee. At a minimum, such quarterly reports will be made on March 31, 2017, June 29, 2017, September 29, 2017, and December 1, 2017. The DFCI CNO (or her designee) will promptly address any instances of non-compliance. DFCI Inpatient Hospital – Patient Transport Arrangement DFCI’s Chair of the CPR Committee will monitor on a quarterly basis to assess compliance with the updated policy and practices regarding the responsibility of DFCI staff and clinicians to respond to all codes in DFCI’s inpatient hospital, and, where necessary, to obtain urgent transport of patients who require a higher level of care by calling the appropriate urgent transport team or by calling 9-1-1 Emergency Medical Services (EMS). This POC-specific monitoring will continue for the longer of one (1) year or until Substantial Compliance is 100 achieved for four (4) consecutive quarters. Results of the monitoring will be reported quarterly to the Medical Staff Executive Committee, to the Executive POC Committee and to the Executive Committee of the Board of Trustees. At a minimum, such quarterly reports will be made on March 31, 2017, June 29, 2017, September 29, 2017, and December 1, 2017. Any identified instances of noncompliance will be immediately reported to the DFCI Chief Medical Officer and CNO, who will ensure there is prompt remedial action. Please see Tag A341 for additional details regarding monitoring activities with respect to DFCI’s provider-based outpatient facility located at Hospital #4. 4. QAPI This POC is identified as a QAPI Plan priority, and progress toward commitments set forth in the POC is being monitored through the QAPI program. For each action in the POC, DFCI has identified the following reporting structure: (i) reporting to the Executive POC Committee to ensure coordinated leadership oversight and accountability for sustained compliance with all POC commitments, and (ii) reporting to committees of the Board of Trustees to ensure governing body oversight. Overall progress on the POC is monitored by the QI Committee and the QI/RM Committee in their respective roles responsible for overseeing QAPI function. See Attachment A043-01: POC Governing Body Reporting Figure and Attachment A263-02: QAPI POC Projects. To date, reports on POC progress have been presented to the QI Committee on February 2, 2017 and February 28, 2017, and to the QI/RM Committee on December 9, 2016 and February 3, 2017. In addition, an update was provided to the Board of Trustees on January 30, 2017. 5. Responsible Leader DFCI CNO, with assistance from the SVP HR 101 102 Tag A409 Blood Transfusions and IV Medications Completion date: January 4, 2017 1. Corrective Action DFCI wishes to clarify it has always administered blood transfusion and intravenous medications to its inpatients in accordance with Massachusetts law and approved medical staff policies and procedures. However, as of January 4, 2017, DFCI adopted separate and independent blood transfusions and intravenous medications administration policies for its inpatient hospital. See Attachments A409-01: Blood Administration Policies. These policies are part of the Institute’s newly adopted Inpatient Hospital Manual, as described in Tag A043. 2. Communication/Education DFCI’s separate and independent blood transfusions and intravenous medication administration policies were “live” on the Institute’s internal policy manual site as of November 21, 2016. Such policies are available electronically and accessible at nursing workstations within the DFCI inpatient hospital. As of on January 4, 2017, the DFCI inpatient ND and CS provided the DFCI inpatient nurses with orientation to and education on the new Inpatient Hospital Manual, including the blood products administration policies. DFCI inpatient nurses will be informed of changes to nursing policies and procedures through an email list serve. Training and education was supplied by DFCI staff through a combination of in-person and electronic educational modalities, including HealthStream training and communication blasts. Training and education was mandatory and attendance/participation documented. 3. Monitoring Beginning March 1, 2017 and monthly thereafter, DFCI’s CNO (or her designee) will interview a sample of fifteen (15) DFCI inpatient nurses to evaluate their: (1) ability to locate the Institute’s inpatient hospital policies, and (2) substantive knowledge of the Institute’s inpatient hospital policies. This POC-specific monitoring will continue for the longer of one (1) year or until Substantial Compliance is achieved for four (4) consecutive quarters. Results of the monitoring are reported quarterly to the Executive POC Committee and to the Board QI/RM Committee. At a minimum, such quarterly reports will be made on April 28, 2017, July 27, 2017, October 27, 2017 and December 8, 2017 to the QI/RM Committee. Any identified instances of noncompliance are immediately reported to the DFCI CNO for prompt remedial action. 4. QAPI This POC is identified as a QAPI Plan priority, and progress toward commitments set forth in the POC is being monitored through the QAPI program. For each action in the POC, DFCI has identified the following reporting structure: (i) reporting to the Executive POC Committee to ensure coordinated leadership oversight and accountability for sustained compliance with all POC commitments, and (ii) reporting to committees of the Board of Trustees to ensure governing body oversight. Overall progress on the POC is monitored by the QI Committee and the QI/RM Committee in their respective roles responsible for overseeing QAPI function. See 103 Attachment A043-01: POC Governing Body Reporting Figure and Attachment A263-02: QAPI POC Projects. To date, reports on POC progress have been presented to the QI Committee on February 2, 2017 and February 28, 2017, and to the QI/RM Committee on December 9, 2016 and February 3, 2017. In addition, an update was provided to the Board of Trustees on January 30, 2017. 5. Responsible Leader DFCI CNO 104 42 CFR 482.24 Medical Record Services 105 MWW Tag A431 Medical Record Services Completion Date – March 1, 2017 Corrective Action Dana-Farber Cancer Institute (DFCI or the Institute) is committed to having an independent medical record service that has administrative responsibility for medical records, including medical records for DFCI inpatients. To ensure compliance with this Condition, DFCI is undertaking two comprehensive corrective actions. First, DFCI’s health information services (HIS) department now has responsibility for DFCI’s inpatient hospital records. Second, DFCI is restructuring its existing electronic medical record (EMR) platform (i.e., the Epic EMR) to provide a discernible, independent medical record for every individual evaluated or treated in the hospital, including DFCI inpatients. Medical Records Services Department DFCI’s independent medical records services department, i.e., the Health Information Services Department (HIS Department), assumed medical record services department responsibilities for DFCI’s hospital inpatients on October 6, 2016. The reorganized HIS Department’s responsibilities include: Storage: DFCI’s HIS Department is responsible for the scanning and processing of the DFCI inpatient hospital medical records. Release of information (ROI): DFCI’s HIS Department is responsible for the ROI for DFCI inpatient hospital records to authorized individuals. On September 7, 2016, DFCI entered into a contract with a third-party vendor (CIOX Health) to assist with the ROI responsibilities. The vendor began assisting DFCI with these responsibilities on October 6, 2016. In response to DPH’s October 21, 2016 letter requesting a “copy of the agreement with CIOX Health”, a copy of its agreement with CIOX Health is attached here. See Attachment A431-01: Agreement with CIOX Health. Chart analysis/completion: DFCI’s HIS Department is responsible for reviewing DFCI inpatient hospital records for completeness and for following up with appropriate providers to ensure completeness, consistent with DFCI’s medical records policies and procedures. DFCI’s HIS Department has revised and approved six (6) policies to reflect its new responsibility for the medical records of the inpatient hospital. See Attachments A431-02 to A431-07. Independent Medical Record DFCI’s EMR is on the Epic medical records platform. Restructuring of an existing Epic EMR system involves the work of internal staff, as well as staff at Epic (our EMR vendor) and our Information Technology (IT) vendor. These changes are being coordinated in a systematic 107 manner over a span of time dictated in part by Epic’s timeline for the provision of services. DFCI established an independent EMR for DFCI’s hospital inpatients via a two-phase process that concluded March 1, 2017. As a result, new DFCI admissions no longer have a continuous EMR with Hospital #2. In response to DPH’s October 21, 2016 letter asking for the “date that DFCI will begin to assign MRN’s to their inpatients,” DFCI respectfully clarifies that the Institute has always assigned a medical record number (MRN) to all of its patients – inpatients and outpatients. The DFCI MRN, however, has not been instantly apparent on an inpatient’s chart. Therefore, as previously described in DFCI’s September 13, 2016 Plan of Correction, the DFCI MRN was added to the EMR patient chart header on January 4, 2017. Phase I: This phase clearly and distinctly identifies DFCI in the Epic platform. DFCI appears as a separate hospital entity from other hospitals on the Epic platform when locating a DFCI-admitted hospital inpatient. The DFCI MRN for hospital inpatients was added to the EMR patient chart header. Printed ROI materials appropriately include the DFCI logo, address, and patient MRN. The DFCI MRN appears on the wristband for patients admitted to the DFCI inpatient hospital. In response to DPH’s October 21, 2016 letter requesting “documentation to indicate when Phase I of the process is completed and any other benchmarks outlined [in our] work toward achieving compliance”, please see the following more detailed timeline for completion of Phase I and Attachments A431-08: Evidence of Approved Modifications to Epic Platform and A263-02: QAPI POC Project: Milestone Target Completion Dates/Due Dates DFCI presents required EMR changes to EMR and IT vendors Completed August 16, 2016 EMR vendor and IT vendor present project proposal (e.g., software specifications) to DFCI Completed September 30, 2016 DFCI approves (with some modifications) EMR vendor project proposal Completed October 11, 2016 IT vendor rebuilds EMR software Completed December 2, 2016 EMR testing for software changes Completed December 21, 2016 Staff training December 2, 2016 to January 3, 2017* 108 Go-live with Phase I/new EMR rebuild January 4, 2017 (completed ahead of schedule) *As of February 28, 2017, training and education is over 99% complete for Phase1 and will be completed by March 31, 2017. Staff who do not complete this required training are not permitted to provide care for DFCI inpatients until they do so. Phase II: In this phase, a distinct medical record will be created for all new admissions to the DFCI inpatient hospital. Instead of DFCI inpatients displaying as admissions into Hospital #2, DFCI inpatients will display as DFCI admissions. Documentation of services purchased under arrangement by DFCI from other providers (including Hospital #2) will be a part of the DFCI EMR. DFCI inpatient admissions will be separate and distinct encounters in the Epic platform from Hospital #2 admissions/encounters. A more detailed timeline for completion of Phase II is as follows: Milestone Target Completion Dates/Due Dates DFCI presents required EMR changes to EMR and IT vendors Completed August 16, 2016 EMR vendor and IT vendor present project proposal (e.g., software specifications) to DFCI Completed September 30, 2016 Identify affected workflows and develop options for review Completed November 11, 2016 DFCI approves changes to workflow Completed December 16, 2016 IT vendor rebuilds and tests EMR software Completed February 14, 2017 Train DFCI staff and providers February 1, 2017 to February 24, 2017* Completed March 1, 2017 Go Live with Phase II/Independent Medical Record 109 *As of February 28, 2017, training and education is 95% complete for Phase 2 and will be completed by March 31, 2017. Staff who do not complete this required training are not permitted to provide care for DFCI patients until they do so. 1. Communication/Education Medical Records Services Department As of October 6, 2016, DFCI’s HIS Department Director completed training and education of the DFCI HIS Department (approximately 30 individuals) on the revised DFCI HIS policies and procedures, including DFCI’s responsibility over the medical record services for the DFCI’s hospital inpatients. Training of HIS Department staff was conducted by the HIS Department Director and his designee during staff meetings and in one-on-one in-person trainings. Attendance was mandatory and participation was documented. Any staff members who were on leave were required to complete training before returning to their positions. In response to DPH’s October 21, 2016 letter requesting “Go Live training”, See Attachment A431-09: Training and Education Activities for HIS Department for course material and training and education activities. DFCI’s HIS Department Director also trained and educated the third party vendor (CIOX Health) on its contracted service role in fulfilling ROI requests for DFCI’s hospital inpatients prior to implementation of the contract with the ROI vendor. Training with the vendor was conducted inperson. Participation was mandatory and documented. In response to DPH’s October 21, 2016 letter requesting “Go Live training”, See Attachment A431-09: Training and Education Activities for HIS Department for course material and training and education activities. Independent Medical Record Training and education for DFCI staff was delivered in phases in conjunction with the phased implementation of the independent medical record for DFCI’s hospital inpatients. Starting in December 2016, DFCI’s Medical Director of Inpatient Oncology, the Medical Director of Inpatient Quality, and the inpatient Nurse Director were responsible for ensuring training and education of applicable staff members who provide care in the DFCI inpatient hospital of the changes that occurred in Phase I and II, and the need to ensure DFCI has an independent medical record. This training and education was provided via presentations attached to emails (with receipt confirmed). As of February 28, 2017, training and education is over 99% complete for Phase 1 and 95% for Phase II. All Phase I and II training and education will be completed by March 31, 2017. Staff who do not complete this required training are not permitted to provide care for DFCI inpatients until they do so. Training and education on Phases I and II are mandatory and attendance/participation documented. 2. Monitoring of Compliance Medical Records Services Department DFCI’s HIS Department will ensure Substantial Compliance with revised medical record services department policies and procedures as follows: 110 Storage: DFCI HIS Department is conducting and will continue to conduct monthly audits of ten (10) DFCI inpatient records to ensure all documentation is scanned correctly into the EMR and is accessible to staff. This monitoring will continue for the longer of one (1) year or until “Substantial Compliance” is achieved for four (4) consecutive quarters. “Substantial Compliance,” as defined throughout this POC, means a collective 90% compliance for those indicators monitored in any given Tag. Results of the monitoring will be reported quarterly for one year to the Executive Plan of Correction (POC) Committee and Board of Trustees Audit and Compliance Committee. At a minimum, such quarterly reports will be made on March 23, 2017, June 22, 2017, October 12, 2017 and December 14, 2017 to the Board of Trustees Audit and Compliance Committee. Any identified instances of noncompliance will be immediately reported to the HIS Director and the CIO who will ensure there is prompt remedial action. The results for October 2016 – January 2017 monitoring activities are attached. The January 2017 results were 100%. See Attachment A263-02: QAPI POC Projects. ROI: DFCI’s HIS Department is conducting and will continue to conduct monthly audits of ten (10) ROI requests received by DFCI to ensure that DFCI independently responds and releases such hospital inpatient records and that Hospital #2 has no role. Any ROI requests misdirected to Hospital #2 will be promptly provided to DFCI by Hospital #2. This monitoring will continue for the longer of one (1) year or until Substantial Compliance is achieved for four (4) consecutive quarters. Results of the monitoring will be reported quarterly for one (1) year to the Executive POC Committee and the Board of Trustees Audit and Compliance Committee. At a minimum, such quarterly reports will be made on March 23, 2017, June 22, 2017, October 12, 2017 and December 14, 2017 to the Board of Trustees Audit and Compliance Committee. Any identified instances of noncompliance will be immediately reported to DFCI Chief Information Officer (CIO) who will ensure there is prompt remedial action. The results for October 2016 – January 2017 monitoring activities are attached. The January 2017 results were 100%. See A263-02: QAPI POC Projects. Chart Completion: DFCI’s HIS Department is conducting and will continue to conduct monthly audits of ten (10) DFCI hospital inpatient charts to verify record completion. This monitoring will continue for the longer of one (1) year or until is achieved for four (4) consecutive quarters. Results of the monitoring will be reported quarterly for one (1) year to the Executive POC Committee and Board of Trustees Audit and Compliance Committee. At a minimum, such quarterly reports will be made on March 23, 2017, June 22, 2017, October 12, 2017 and December 14, 2017 to the Board of Trustees Audit and Compliance Committee. Any identified instances of noncompliance will be immediately reported to DFCI’s Medical Director of Inpatient Oncology, Medical Director of Inpatient Quality, and/or Inpatient Nurse Director, as applicable, who will ensure there is prompt remedial action. In response to DPH’s October 21, 2016 letter requesting, “Documentation to indicate the chart review was completed.” The results October 2016 – January 2017 111 monitoring activities are attached. The January 2017 results were 90% compliance. See A263-02: QAPI POC Projects. In response to DPH’s October 21, 2016 letter requesting the “methodology [that] the Governing Body [will] use to ensure that the DFCI existing independent medical record service includes inpatient services”, the DFCI’s Board of Trustees Audit and Compliance Committee will receive routine reports described above. These three reports will allow the Governing Body to evaluate whether DFCI’s HIS Department is appropriately including inpatient services. Independent Medical Record The monitoring for each phase will ensure staff understanding and compliance with the changes as follows: Phase I: DFCI’s Quality and Patient Safety Department will conduct monthly random audits by interviewing fifteen (15) staff members working in the DFCI inpatient hospital. The purpose of this monitoring is to assure that staff can demonstrate that they can locate and differentiate patients in the EMR for patients in the DFCI inpatient hospital and identify the DFCI MRN for hospital inpatients. This monitoring has begun and will first be reported beginning March, 2017 and will continue for the longer of one (1) year or until Substantial Compliance is achieved for four (4) consecutive quarters. Results of these monitoring activities will be reported on a quarterly basis for one (1) year to the Executive POC Committee and the Board of Trustees Audit and Compliance Committee (to begin March 23, 2017, June 22, 2017, October 12, 2017 and December 14, 2017). Any identified instances of noncompliance will be immediately reported to DFCI’s Medical Director of Inpatient Oncology, Medical Director of Inpatient Quality, and/or Inpatient Nurse Director, as applicable, who will ensure there is prompt remedial action. Phase II: DFCI’s HIS Department will randomly select on a weekly basis ten (10) DFCI hospital inpatient charts for review. The purpose of this monitoring is to ensure the DFCI medical record is complete and remains separate from Hospital #2 for each admission. This monitoring will begin March 2017 and continue for the longer of one (1) year or until Substantial Compliance is achieved for four (4) consecutive quarters. Results of these monitoring activities will be reported on a quarterly basis for one year to the Executive POC Committee and the Board of Trustees Audit and Compliance Committee (to begin June 22, 2017, October 12, 2017 and December 14, 2017). Any identified instances of noncompliance will be immediately reported to DFCI’s Medical Director of Inpatient Oncology, Medical Director of Inpatient Quality, Inpatient Nurse Director, as applicable, who will ensure there is prompt remedial action. The DFCI Medical Records Responsible Leader reports monthly to the Executive POC Committee and the Board of Trustees Audit and Compliance Committee on the two-phased Epic EMR restructuring process of establishing an independent EMR for DFCI’s hospital inpatients. Reports include timely updates on the restructuring progress, including design and implementation, and the status for rollout of each component of Phases I and II. The DFCI Medical Records Responsible Leader will report these monitoring activities on a monthly basis to the Executive POC Committee and the Board of Trustees Audit and Compliance Committee until the completion of phase II of the EMR restructuring. 3. QAPI 112 This POC is identified as a QAPI Plan priority, and progress toward commitments set forth in the POC is being monitored through the QAPI program. For each action in the POC, DFCI has identified the following reporting structure: (i) reporting to the Executive POC Committee to ensure coordinated leadership oversight and accountability for sustained compliance with all POC commitments, and (ii) reporting to committees of the Board of Trustees to ensure governing body oversight. Overall progress on the POC is monitored by the QI Committee and the QI/RM Committee in their respective roles in overseeing QAPI function. See Attachment A043-01: POC Governing Body Reporting Figure and Attachment A263-02: QAPI POC Projects. To date, reports on POC progress have been presented to the QI Committee on February 2, 2017 and February 28, 2017, and to the QI/RM Committee on December 9, 2016 and February 3, 2017. In addition, an update was provided to the Board of Trustees on January 30, 2017. 4. Responsible Leader DFCI Chief Information Officer 113 114 Tag A432 Organization and Staffing Completion Date – October 6, 2016 1. Corrective Action As described in greater detail in the above response to Tag A431, by October 6, 2016, to ensure compliance with this Standard, the organization of DFCI’s medical record service (i.e., HIS Department) has been aligned to be appropriate to the scope and complexity of the services required for DFCI’s hospital inpatients. DFCI employs adequate personnel to ensure prompt completion, filing and retrieval of records. As of October 6, 2016, the HIS Department’s existing employees, in conjunction with ROI services obtained from a third party vendor under contract with DFCI (as described above) fulfill the medical record services needs of the DFCI’s inpatient hospital population, including ensuring prompt completion, filing and retrieval of records. DFCI, and in particular its Board of Trustees, remain responsible for services provided directly by DFCI staff and those services provided under contract or arrangement. As of October 6, 2016, DFCI hospital inpatients submit ROI authorizations to DFCI’s HIS Department. DFCI’s HIS Department independently fulfills each inpatient’s request. If an inpatient inadvertently submits an ROI authorization to Hospital #2, Hospital #2 forwards the request to DFCI for fulfillment. 2. Communication/Education As of October 6, 2016, DFCI’s HIS Department Director completed training and education of the DFCI HIS Department (approximately 30 individuals) on the revised DFCI HIS policies and procedures, including DFCI’s responsibility over the medical record services for the DFCI’s hospital inpatients. Training of HIS Department staff was conducted by the HIS Department Director and his designee during staff meetings and in one-on-one in-person trainings. Attendance was mandatory and participation was documented. Any staff members who were on leave were required to complete training before returning to their positions. DFCI’s HIS Department Director also trained and educated the third party vendor (CIOX Health) on its contracted service role in fulfilling ROI requests for DFCI’s hospital inpatients prior to implementation of the contract with the ROI vendor. Training with the vendor was conducted inperson. Participation was mandatory and documented. 3. Monitoring of Compliance On a monthly basis, DFCI’s HIS Department has begun and will continue to audit ten (10) inpatient ROI requests and vendor activities to evaluate whether DFCI’s HIS department is fulfilling its medical record services department duties for DFCI hospital inpatients consistent with DFCI’s revised medical records policies, including independently fulfilling inpatient ROI requests. Any ROI requests misdirected to Hospital #2 have been and will continue to be promptly transferred to DFCI by Hospital #2. This monitoring will continue for the longer of one (1) year or until Substantial Compliance is achieved for four (4) consecutive quarters. Results of these monitoring activities will be reported on a quarterly basis for one (1) year to the Executive POC Committee and the DFCI’s Board of Trustees Audit and Compliance Committee. At a minimum, such quarterly reports will be made on June 22, 2017, October 12, 2017 and December 14, 2017 to the Board of Trustees Audit and Compliance Committee. 115 Any identified instances of noncompliance will be immediately reported to the DFCI CIO and HIS Director who will ensure there is prompt remedial action. The monitoring results demonstrate 100% compliance with Release of Information (ROI) obligations every month. The results for October 2016 to January 2017 are attached. See Attachment A263-02 QAPI POC Projects. 4. QAPI This POC is identified as a QAPI Plan priority, and progress toward commitments set forth in the POC is being monitored through the QAPI program. For each action in the POC, DFCI has identified the following reporting structure: (i) reporting to the Executive POC Committee to ensure coordinated leadership oversight and accountability for sustained compliance with all POC commitments, and (ii) reporting to committees of the Board of Trustees to ensure governing body oversight. Overall progress on the POC is monitored by the QI Committee and the QI/RM Committee in their respective roles in overseeing QAPI function. See Attachment A043-01: POC Governing Body Reporting Figure and Attachment A263-02: QAPI POC Projects. To date, reports on POC progress have been presented to the QI Committee on February 2, 2017 and February 28, 2017, and to the QI/RM Committee on December 9, 2016 and February 3, 2017. In addition, an update was provided to the Board of Trustees on January 30, 2017. 5. Responsible Leader DFCI Chief Information Office, with assistance from the DFCI HIS Director 116 WW Tag A450 Medical Record Services Completion Date – October 6, 2016 1. Corrective Action Medical Record Completion DFCI is committed to ensuring that its inpatient medical record entries are legible, complete, dated, timed, and authenticated in written and/or electronic form by the person responsible for providing (or evaluating) the service provided, consistent with Institute policies and procedures. To ensure compliance with this standard, effective October 6, 2016, DFCI’s HIS Department assumed responsibility for reviewing DFCI hospital inpatient records for completeness and for following up with appropriate providers to ensure completeness. Proper Identification of Protocol Regimen Orders With respect to the surveyors’ observation in the survey findings regarding electronically generated medication orders that were not identified with patient names for proper identification, DFCI wishes to clarify that the printed pages that were reviewed by surveyors were not the medication orders for a specific patient. Rather, these pages were printed from an internal database of standard cancer medication regimens and research protocols that are used as a reference document by nurses and pharmacists to cross check the electronic medication orders to the standard regimen or protocol. This process is done to ensure the actual patient-specific orders are correct in terms of the medication “rights” including drug, dose, time, duration, and route. Notwithstanding the foregoing, in the interest of preventing a misunderstanding, as of October 6, 2016, a label with patient specific information (with at least 2 identifiers) is placed on these and any other paper documents prior to being placed in a patient binder. In addition, a notice has been added to the front cover of each patient binder reminding all DFCI staff to label all paper documentation with patient specific identifiers. See Attachment A450-01: Photograph of Binder with Reminder Label that includes Patient Specific Identifiers. Documentation of Procedure Consents With respect to the surveyors’ observation that consent for placement of a tunneled catheter was not timed, DFCI has three (3) corrective actions. First, on September 15, 2016, the DFCI Chief Medical Officer informed Hospital #2, which performs the placement of tunneled catheter for our inpatients under arrangements, of the need to re-educate their staff on appropriate consent documentation policies and procedures no later than October 6, 2016. The clinical leadership of Hospital #2 re-educated their staff on appropriate consent documentation on September 20, 2016. See Attachment A450-02: Communication between DFCI CMO informing Hospital #2 of the need to reeducate their staff and Attachment A450-03: Communication of Clinical Leadership of Hospital #2 reeducating staff. Second, effective as of October 6, 2016, as the DFCI’s HIS Department performs its chart completeness evaluation responsibilities, the DFCI’s HIS Department staff member identifies any instances where Hospital #2’s staff fails to appropriately document the time that consent for catheter placement is secured. Third, DFCI’s HIS Department evaluates the completeness of consent forms, ensuring that all fields (e.g., 118 risks, benefits, alternatives to treatment, signatures, date, and time) are completed by Hospital #2’s staff. Documentation of Blood Transfusion Records With respect to the surveyors’ observation that patient blood transfusion records did not contain the discipline of the staff member who verified the patient’s informed consent as well as the unit of blood to the patient’s identification, DFCI completed a corrective action to resolve this issue effective August 9, 2016. Specifically, a new electronic dual verification system for blood product administration was implemented that details in the record both the names and disciplines of the staff members who performed the unit of blood verification to the patient’s identification. In addition, the DFCI EMR provides details of the individual, including his/her discipline, who confirms informed consent for blood transfusions. Screenshots demonstrating new system were previously attached as attachment 13 in September 13, 2016 POC submission. 2. Communication/Education Medical Record Responsibility and Completion As described above, as of October 6, 2016, DFCI’s HIS Department Director trained and educated the DFCI HIS Department (approximately 30 individuals) and the contracted-for third party vendor on assuming responsibility over the medical record services described above for the DFCI’s hospital inpatients. Training of HIS Department staff was conducted during staff meetings, in one-on-one in-person trainings. Attendance was mandatory and participation was documented. Any staff members who were on leave are required to complete training before returning to their positions. On September 30, 2016, DFCI’s Medical Director of Inpatient Oncology and Medical Director of Inpatient Quality initiated training and education of inpatient hospital nurses, unit coordinators, physician assistants and physicians on the need for a complete medical record for each inpatient, including ensuring that all documents placed in a patient’s binder include patient specific information (i.e., at least two identifiers), prior to being placed in the binder. Training and education were conducted via email communications (with receipt confirmed), staff meetings, and by adding reminders in appropriate physical locations and on the front of the patient binder. Training was mandatory and attendance/participation documented. Any staff members on leave are required to complete training before returning to their positions. Proper Identification of Protocol Regimen Orders and Documentation of Procedure Consents By October 3, 2016, the DFCI’s HIS Director educated DFCI’s HIS Department via staff meetings and one-on-one meetings to examine whether documents, including consents, secured by contracted service providers are appropriately authenticated. Documentation of Blood Transfusion Records Upon go-live of the new electronic dual verification system for blood product administration in August 2016, applicable staff who provide care in the DFCI hospital inpatient location were educated on the new feature by an educational email. In addition, starting on September 30, 2016, DFCI clinical leaders included refresher education to clinical staff (including nurses) via 119 email communications (with receipt confirmed) and staff meetings, to document their credentials on a paper form in the event that electronic documentation is not possible (for example, EMR downtime). See Attachment A431-09: Training and Education Activities for HIS Department and Attachment A450-04 to A450-07: EMR Training Material. 3. Monitoring of Compliance Medical Record Completion As described in response to Tag A431, DFCI has begun and will continue to conduct the necessary monitoring activities to ensure that DFCI inpatient medical entries are legible, complete, dated, timed and authenticated in written or electronic form by the person responsible for providing the services (or the person evaluating the service provided) consistent with DFCI policies and procedures. DFCI’s HIS Department has begun and will continue to conduct monthly audits of ten (10) DFCI inpatient hospital charts to verify record completion. This monitoring will continue for the longer of one (1) year or until Substantial Compliance is achieved for four (4) consecutive quarters. Results of the monitoring will be reported quarterly for one (1) year to the Executive POC Committee and the Board of Trustees Audit and Compliance Committee. At a minimum, such quarterly reports will be made on March 23, 2017, June 22, 2017, October 12, 2017 and December 14, 2017 to the Board of Trustees Audit and Compliance Committee. Any identified instances of noncompliance will be immediately reported to DFCI’s Medical Director of Inpatient Oncology, Medical Director of Inpatient Quality, and/or Inpatient Nurse Director, as applicable, and/or HIS Department staff who will ensure there is prompt remedial action. The October 2016 to January 2017 monthly data were also sent to inpatient hospital leadership, shown in Attachment A450-08: January Monthly Report to Inpatient Hospital Leadership. For the months of October 2016 to January 2017, DFCI’s HIS Department reviewed ten (10) DFCI inpatient hospital charts to verify record completion. As mentioned in Tag A431, the results for these monitoring activities are attached. The January 2017 monthly results were 90% compliant. See Attachment A263-02 QAPI POC Projects. Proper Identification of Protocol Regimen Orders DFCI has begun and will continue to conduct necessary monitoring activities to ensure that labels with patient specific information (with at least two (2) identifiers) are added to applicable patient binders and any other paper documents prior to being placed in the binder. Effective October 14, 2016, DFCI reviews all patient binders daily for the longer of six (6) months or until substantial compliance has been achieved for six (6) consecutive months to ensure that all paper documents are labeled with patient specific information. Further, beginning November 1, 2016, the DFCI’s HIS Department audits thirty (30) random charts a month for properly labeled documentation. This latter monitoring activity will continue for one (1) year or until Substantial Compliance is achieved for three consecutive quarters. Results of the monitoring are reported on a quarterly basis to the Executive POC Committee and the Board of Trustees Audit and Compliance Committee. At a minimum, such quarterly reports will be made on March 23, 2017, June 22, 2017, and October 12, 2017 to the Board of Trustees Audit and Compliance Committee. Any identified instances of noncompliance are immediately reported to DFCI’s Medical Director of Inpatient Oncology, Medical Director of Inpatient Quality, and/or Inpatient Nurse Director, as applicable, who will ensure there is prompt remedial action. 120 For the months of October 2016 to January 2017, the daily inpatient binder review monitoring results are attached. See Attachment A450-08: January Monthly Report to Inpatient Hospital Leadership. The January 2017 results were 97% compliant. Any occurrence of non-compliance is, or will be, immediately reported to the Nurse Director for prompt remedial action. Additionally, the monthly audit results are attached. See Attachment A263-02: QAPI POC Projects. Documentation of Procedure Consents On a quarterly basis, DFCI’s HIS Department produces a report to identify inpatients who have undergone procedures by providers under arrangements to audit thirty (30) consents to evaluate whether all fields were appropriately completed. This monitoring will continue for the longer of one (1) year or until Substantial Compliance is achieved for four (4) consecutive quarters. Results of the monitoring are reported on a quarterly basis for one year to the Executive POC Committee and the Board of Trustees Audit and Compliance Committee. At a minimum, such quarterly reports will be made on March 23, 2017, June 22, 2017, October 12, 2017 and December 14, 2017 to the Board of Trustees Audit and Compliance Committee. Any identified instances of noncompliance are immediately reported to DFCI’s Medical Director of Inpatient Oncology, Medical Director of Inpatient Quality, Inpatient Nurse Director, as applicable, who will ensure there is prompt remedial action. In addition, DFCI will evaluate the completeness of documentation by Hospital #2’s staff. DFCI HIS began these auditing and monitoring activities in November 2016. The January 2017 results were 90% compliant. Documentation of Blood Transfusion Records On a quarterly basis, DFCI’s HIS Department runs a report of patients who received blood products and audit thirty (30) patient records to ensure that the discipline of the applicable provider is documented (either electronically or on the paper blood bank slip). This monitoring will continue for the longer of one (1) year or until Substantial Compliance is achieved for four (4) consecutive quarters. Results of the monitoring are reported quarterly for one (1) year to the Executive POC Committee and the Board of Trustees Audit and Compliance Committee. At a minimum, such quarterly reports will be made on March 23, 2017, June 22, 2017, October 12, 2017 and December 14, 2017 to the Board of Trustees Audit and Compliance Committee. In addition, any identified instances of noncompliance are immediately reported to the appropriate DFCI’s Medical Director of Inpatient Oncology, Medical Director of Inpatient Quality, and/or Inpatient Nurse Director, as applicable, who will ensure there is prompt remedial action. DFCI HIS began these auditing and monitoring activities in November 2016. The January 2017 results were 100% compliant. . 4. QAPI This POC is identified as a QAPI Plan priority, and progress toward commitments set forth in the POC is being monitored through the QAPI program. For each action in the POC, DFCI has identified the following reporting structure: (i) reporting to the Executive POC Committee to ensure coordinated leadership oversight and accountability for sustained compliance with all 121 POC commitments, and (ii) reporting to committees of the Board of Trustees to ensure governing body oversight. Overall progress on the POC is monitored by the QI Committee and the QI/RM Committee in their respective roles in overseeing QAPI function. See Attachment A043-01: POC Governing Body Reporting Figure and Attachment A263-02: QAPI POC Projects. To date, reports on POC progress have been presented to the QI Committee on February 2, 2017 and February 28, 2017, and to the QI/RM Committee on December 9, 2016 and February 3, 2017. In addition, an update was provided to the Board of Trustees on January 30, 2017. 5. Responsible Leader(s) DFCI Chief Information Officer (CIO), with assistance from the DFCI HIS Director 122 Attachments Tag number A043-01 A043-02 A043-03 A083-01 A083-02 A083-03 A083-04 A083-05 A083-06 A083-07 A083-08 A115-01 A115-02 A115-03 A115-04 A115-05 A115-06 A263-01 A263-02 A263-03 A263-04 A263-05 A263-06 A263-07 A263-08 A273-01 A273-02 A273-03 A338-01 A341-02 A341-03 Attachment Title Governing Body POC Governing Body Reporting Figure Screenshots of New Policy Manual Location Table of Contents of New Inpatient Hospital Policy Manual Inpatient Hospital Contracted Services Summary Clinical Services Agreement Facilities Operating Agreement Leased Employee Agreement Patient Transport Agreement Professional Services Agreement Space Lease Agreement New England Organ Bank Patient Rights Patient Rights and Responsibilities Notice (Policy 9.14) Patient Complaint/Grievance/Request Management Process (Policy 9.04) Patient Rights Notice (English) Patient Rights Notice (Spanish) Training Material on 9.04 and 9.14 for P/FR and Applicable Staff on Policies 9.04 and 9.14 Training Material for Providers, Support and Administrative Staff on Policies 9.04 and 9.14 QAPI QAPI Plan QAPI POC Projects Populated DFCI Quality Dashboard Inpatient Section of DFCI Patient Safety Dashboard Quality Improvement Committee Charter DFCI Pharmacy and Therapeutics Committee Policy DFCI Pharmacy and Therapeutics Committee Roster Revised & Approved Job Descriptions Approved Revised QI/RM Committee Charter Minutes from September 2016 Pharmacy & Therapeutics Committee Schedule of Meetings Medical Staff Medical Staff Bylaws DFCI - DPH email communication November 14 2016 DFCI-BCH_2016_Patient Transport Agreement 123 A341-04 DFCI-SEMC_2016_Patient Transport Agreement Nursing Services A385-01 Sample DFCI Inpatient Hospital Staffing Schedule A386-01 Revised DFCI Nursing Service Organizational Chart A386-02 DFCI Nursing Job Descriptions A394-01 DFCI’s Human Resources Policy 2.06, Verification of License, Registration or Certification A409-01 Blood Product Administration Policies Medical Records A431-01 Agreement with CIOX Health A431-02 to 6 Policies to Reflect Reorganization of HIS Department to Include Inpatients A431-07 A431-08 Evidence of Approved Modifications to Epic Platform A431-09 Training and Education Activities for HIS Department A450-01 Photograph of Binder with Reminder Label re: Patient Specific Identifiers A450-02 Communication between DFCI CMO informing Hospital #2 of the need to reeducate their staff A450-03 Communication of Clinical Leadership of Hospital #2 re-educating staff A450-04 to EMR Training Material A450-07 A450-08 January Monthly Report to Inpatient Hospital Leadership 124