PRINTED: 11/30/2016 DEPARTMEN I OF HEALTH AND HUMA RVICES FORM APPROVED CENTERS FOR MEDICARE MEDICAID SERVICES OMB NO. 0938-0391 STATEMENT OF DEFICIENCIEs (x1) (x2) MULTIPLE CONSTRUCTION 0(3) DATE SURVEY AND PLAN OF CORRECTION IDENTIFICATION BUILDING COMPLETED 050359 Mitzi/2016 NAME OF PROVIDER OR SUPPLIER STREET ADDRESS. CITY. STATE. ZIP CODE 869 CHERRY AVENUE Tu LA RE, CA 93274 my ID SUMMARY STATEMENT OF DEFICIENCIEs ID PROVIDERS PLAN OF CORRECTION (x5) (EACH DEFICIENCY MusT BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION TAG REGULATORY OR IDENTIFYING INFORMATION) TAG CROSS-REFERENCED To THE APPROPRIATE DATE DEFICIENCY) TULARE REGIONAL MEDICAL CENTER A000 INITIAL COMMENTS A000 The foliowing re?ects the ?ndings of the California Department of Public Health during a Complaint Validation survey. Complaint Number: 510008 Representing the Department: 27137.HFEN 38305, HFEN .31. 21905.HFES Eff. Eff? 22710. Medical Consultant . 35653, Medicai Consultant The census was 38. and the sample size was 6. During the survey. an Immediate Jeopardy (IJ) was called on 11/9/16, at 2:50 PM. regarding surgical services. One surgeon (Medical Doctor 6, performed high risk patients with life threatening conditions, whose surgery posed - i a risk for life threatening complications) and i 1 (taking between two and eight hours) surgical cases without a surgical assistant after hours; despite existing policy and procedure criteria. The hospital had only one Operating Room on?call team to cover all emergency surgeries and emergent Caesarean-section (also known as C?Sections, a procedure where a baby is surgically detivered via a series of incisions into the mother's abdomen) deliveries betWeen 5 PM and 7 AM. The hospital had no plan to enforce existing surgical poiicy and procedures; no criteria to discern different level of surgical classi?cations; no plan on how to develop a second Operatin Room team; no plan on how to incorporate obst trics into surgical procedures policy and pros dures; no plan on how to ensure LABORATORY OR PRWE LIER REPRESENTATIVES SIGNATURE TITLE (X6) DATE 060 .1. MEI) Any de?ciency statement endin??t?nasterisk denotes a de?ciency which the institution may be excused from correcting providing it is determined that other safeguards provide suf?cien protection to the patients . (See instructions.) Except for nursing homes. the findings stated above are disclosable 90 days following the date of survey whether or not a plan of correction is provided. For nursing homes. the above ?ndings and plans of con?ection are disclosable 14 days following the date these documents are made available to the facility. If de?ciencies are cited. an approved plan of correction is requisite to continued prog?ramparticipaiion. 0039- [?70 I 7 FORM Previous Versions Obsolete Event 5P11 Facility ID: CA120001467 If continuation sheet Page 1 of 51 DEPARTMENT OF HEALTH AND HUMAN PRINTE D: 11/30/2016 FORM APPROVED CENTERS FOR MEDICARE MEDICAID IVICES OMB NO. 0938-0391 STATEMENT OF DEFICIENCIES (x1) (x2) MULTIPLE CONSTRUCTION (x3) DATE SURVEY AND PLAN OF CORRECTION IDENTIFICATION A BUILDIN COMPLETED . 050359 B. WING 11/14/2016 NAME OF PROVIDER OR SUPPLIER STREETADDRESS, CITY, STATE, ZIP CODE 869 CHERRY AVENUE TULARE REGIONAL MEDICAL CENTER . TU LARE, CA 93274 .1, (x4) ID SUMMARY STATEMENT OF DEFICIENCIES ID PLAN OF CORRg?irjgN :2 (X5) (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE EJQWLEWON TAG REGULATORY OR LSC IDENTIFYING INFORMATION) TAG CROSS-REFERENCED TO THE APPROPRIATE ?r'f DATE DEFICIENCY) H11: - 3 PO -..I . 9?3} A 000 Continued From page 1 A 000 ?it a surgical assistantwas available per the . standard of surgical practice [Refer to A-940 and willy, 1' 7 (. .. After accepting the hospital's Plan of Correction, the lJ-waS abated on 11/14/16, at 2:30 PM. A 043 A 043 482.12 GOVERNING BODY A 043 fig FIndIng 01/31/17 There must be an effective governing body that is legally responsible for the conduct of the hospital. If a hospital does not have an organized governing body, the persons legally responsible for the conduct of the hospital must carry out the functions speci?ed in this part that pertain to the governing body This CONDITION is not met as evidenced by: Based on interviews and document reviews, the hospital failed to effectively govern the activities and conduct of the hospital's operations to provide safe and quality health care in accordance with the Governing Body (GB) bylaws, as evidenced by: 1. The GB failed to provide appropriate resources and support for surgical services to ensure safe and timely care for approximately 45 surgical patients per month, or approximately 500 surgical patients per year. (taking between 2 and 8 hours), high-risk patients with life threatening conditions, whose surgery posed a risk for life threatening complications), urgent and emergent surgeries were routinely performed during periods when the limited operating room resources (a single on-call surgicai team) were needed to care for multiple surgeries at the same time. This failure resulted in deiays for assessments and surgical Person/s) Responsible: Chief Executive Officer or designee Plan for Correcting: Annually the CEO will work with the Governing Body to approve a budget which provides adequate financial resources for Surgical Services to have an appropriate level of provider and nurse staffing at all times. Quarterly the CEO or designee will monitor the level of resources needed in Surgical Services and report to the Governing Body on this issue as appropriate to ensure that resources are being allocated as indicated in A940. Plan for Improving: Refer to the response in A 940. Procedure for Implementing: Refer to the reSponse in A940. Plan of correction was implemented on 11/09/16. Monitoring Tracking: On a basis the Chief Nursing Officer and Chief Operating Officer will provide to the CEO a report with data as it relates to A940 toensure that follow through is occurring, that appropriate resources are being allocated, and that any variances are being followed up on. 01/31/17 FORM Previous Versions Obsolete Event Facility ID: CA120001467 If continuation sheet Page 2 of 51 DEPARTMENT OF HEALTH AND HUMAN CENTERS FOR MEDICARE MEDICAIL PRINTED: 11/30/2016 FORM APPROVED OMB NO . 0938-0391 2. The failure to ensure that the Medical Staff was accountabte for the quality of care provided to surgical patients when a shortage of operating room resources caused delays in treating high risk surgical cases. The medicai staff failed to implement alternative procedures, or formally request solutions from the Governing Body in a timely manner. The delays put patients at risk for complications and contributed to deterioration and/or alteration in the surgical plan for three of six patient records reviewed (A, B, and C) [Refer to 3. The failure to ensure that surgical services were organized and provided in accordance with hospital policies and acceptable standards of practice, to ensure safe surgical care to all patients when: a. high-risk, urgent and emergent surgeries were routinely performed during periods when the limited operating room resources (a single on-call surgical team) were needed to care for muttiple surgeries at the same time [Refer to Staff to report surgical operational issues if any as discussed further in section A 940. mm: Refer to the response in A 940. Procedure for Implementing: Refer to the response in A940. Plan of correction was implemented on 11/09/16. Monitoring Tracking: Annually the CEO will work with the Governing Body to approve a budget which provides adequate financial resources for Surgical Services to have an appropriate level of provider and nurse staffing at all times. Quarterly the CEO or designee will monitor the level of resources needed in Surgical Services and report to the Governing Body on this issue as appropriate and to ensure that resources are being allocated as indicated in A940. Any variances surfaced by the CNO and COO will be reported to the CEO. Any variance pending longer than 90 days will be reported to MEC and Governing Board. STATEMENT OF DEFICIENCIES (x1) (X2) MULTIPLE CONSTRUCTION (x3) DATE SURVEY AND PLAN OF CORRECTION NUMBER: COMPLETED A. BUILDING 050359 3- 11/1 41201 5 NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, STATE, ZIP CODE 869 CHERRY AVENUE TULARE REGIONAL MEDICAL CENTER TULARE, CA 93274 (X4) ID SUMMARY STATEMENT OF DEFICIENCIEs lD PLAN OF CORRECTION (x5) (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION TAG REGULATORY OR IDENTIFYING INFORMATION) TAG TO THE APPROPRIATE DATE DEFICIENCY) A 043 Continued From page 2 A 043 operations and/or alterations in the surgical plan. Finding #2 These delays/alterations contributed to Person[s[ Resgonsible: deterioration of patient conditions, medical CEO or designee complications, and/or death for three of six Plan for Correcting: patient records reVIewed (A, B, and Governing Body will provide a forum in their regular board meeting for Medical 01/31/17 Finding #3 b. High risk surgeries were performed without Person[s[ Resgonsible: an assistant surgeon [Refer to CEO or designee Plan for Correcting: 0- The had only one Operating Room CEO will coordinate with Governing Body to on?call surgIcal team to cover all emergency surgeries and emergent Caesarean sections '1 - (also known as a C-section, a surgical procedure 1 FORM Previous Versions Obsolete Event Facility ID: CA120001467 Tn??tinug?t?r?l sheath?age Di." . I a . OF 'i'i-i ANT.) HUMAN F?F?ilN'i'i: FORM APPROVED CENTERS FUR i1- OMB NC). 0938?0391 r?i- r1-: mourn.itcsuri'i My; murmur; aunt-'13: connrmou nor unmet-i? A W1 compii'iru res W-NG 050359 1fl1412016 NAME or on super. ?In s'r crry, STATE, an com 869 CHERRY AVENUE TULARE REGIONAL MEDICAL CENTER TULARE, CA 93274 (X4) in SUMMARY STATEMENT or .o PROVIDERS PLAN or CORRECTION (st pREle i (EACH DEFICIENCY must as PRECEDED av PREFIX i (EACH CORRECTIVE snoum er; TAG i REGULATORY OR [.550 IDENTIFYING INFORMATION) TAG CROSS-REFERENCED to THE APPROPRIATE DATE A 043 Continued From page 3 used to deliver a baby through incisions in the mother's abdomen) between 5 PM, and 7 AM. The hospital had no plan to enforce their existing policy and procedures regarding surgical services; no criteria to discern different levels of surgical classi?cations; no plan on how to develop a second Operating Room surgical team; no plan on how to incorporate obstetrics into surgery policies and procedures [Refer to These failures resulted in delays for assessments and surgical operations and/or alterations In the surgical plan. These delays/alterations put all surgical patients at risk, and contributed to deterioration of patient conditions, medical complications, and/or death for three of six patient records reviewed (A, B, and C). Findings: Review of the 5/22/13 Governing Body bylaws documented underArticle l, Section 3-a Mission, "To provide safe, ef?cient, technologically advanced healthcare with respect for the diversity of our region." Section 3-c Values documented, "Quality: To provide high-quality care, based on the best practices and in collaboration with Medical Staffthat exceeds patient expectations The GB bylaws Article iil, Section 2-c, noted that the GB "shall determine the policies and procedures and shall have control ofand be responsible for the overall operations and affairs of the district and its facilities, according to the best interests of the communities served by the District." Article Vii, Section 5-a documented that the GB "shall assure that there is an ef?cient, I effective, comprehensive and integrated solution focused Quality of Care/Patient Safety and ensure that the plan stated in A 940 is adhered to and that the standard hours of i operations are adhered to. I Plan for improving: Refer to the response in A 940. I Procedureforimplementing: Refer to the response in A940. Plan of correction was implemented on 11/09/16. Momwj?s?mgi Annually the CEO will work with the Governing Body to approve a budget which provides adequate financial resources for" Surgical Services to have an appropriate level of provider and nurse staffing at all times. Quarterly the CEO or designee will I monitor the level of resources needed in Surgical Services and report to the Governing Body on this issue as appropriate and to ensure that resources are being allocated as indicated in A940. Previous Versrons Obsolete Event ID TDSP11 Facillty ID. CA120001467 lf continuation sheet Page 4 of 51 DEPARTMENT OF HEALTH AND HUMAN PTRVICES PRINTED: 11/30/2016 FORM APPROVED OMB NO. 0938-0391 CENTERS FOR MEDICARE MEDICAIL . STATEMENT OF DEFICIENCIES (X1) (x2) MULTIPLE CONSTRUCTION (x3) DATE SURVEY AND PLAN OF CORRECTION IDENTIFICATION NUMBER: COMPLETED A BUILDING 050359 3- WING NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE 869 CHERRY AVENUE TULARE REGIONAL MEDICAL CENTER TULARE, CA 93274 (x4) (D SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDERS PLAN OF CORRECTION (x5) pREf-?Ix (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION TAG REGULATORY OR LSC IDENTIFYING INFORMATION) TAG CROSS-REFERENCED TO THEAPPROPRIATE DATE DEFICIENCY) A 043 Continued From page 4 A043 . . [73. Performance Improvement Program." Article VII, i ?Lfv Section 5-c directed the medical staff and district 53,1313; staffto ?implement and report on the activities LIEE {if and mechanisms for monitoring and evaluating 1252, 7'3: the quality of patient care, for identifying and L.) ff resolving patient care problems, and for 59:: identifying opportunities to improve patient care." r111}, ft": as . . The cumulative effect of these systemic problems 23:33 resulted in the hospitai's inability to comply with mfg? L, the statutorily-mandated Condition of Participation Tag A 049 01/21/17 for Governing Body. Person Resgonsible: A 049 MEDICAL STAFF - A 049 chief of Staff, MEG ACCOUNTABILITY [The governing body must] ensure that the medical staffis accountable to the governing body for the quality of care provided to patients. This STANDARD is not met as evidenced by: Based on interviews and document reviews, the Governing Body (GB) failed to ensure the Medical Staff was accountable for the quality of care provided to surgical patients when a shortage of operating room resources caused delays in treating high risk patients with life threatening conditions, whose surgery posed a risk for life threatening complications) surgical cases; the Medical Staff failed to implement alternative procedures or formaliy request solutions from the GB in a timely manner, in accordance with Medical Staff bylaws and policies. The delays put patients at risk for complications and contributed to deterioration and/or alteration in the surgical plan for three of six patient records reviewed (A, B, and C). Findings: Plan for Correcting: The Chief of Staff or designee from the MEC will report to the Governing Body all findings from monitoring all after hours surgical cases and cases that failed to have an assistant surgeon when required. Starting with 01/25/17 Board Meeting and 1/11/2017 MEC meeting this will surface as a regular standing agenda item in the MEC. The Chief of Staff or designee will present all resources available (refer to A 940) for surgical cases and a report of resources needed for surgical cases to the Governing Body. An alternative plan (A 940) has been put in place as of 11/09/16. As follows: 0 The hospital will follow the Code Triage Internal (Disaster) policy #21?2009, (which includes that staff may be requested to stay on duty and Off-duty personnel would be called to report to their FORM Previous Versions Obsolete Event Facility ID: CA120001467 If continuation sheet Page 5 of 51 DEPARTMENT OF HEALTH AND HUMAN PRINTED: 11/30/2016 FORM APPROVED CENTERS FOR MEDICARE MEDICAIL OMB NO. 0938-0391 STATEMENT OF DEFICIENCIES (x1) (x2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A BUILD COMPLETED 050359 3- 11/14/2016 NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE 869 CHERRY AVENUE TULARE REGIONAL MEDICAL CENTER TU LARE, CA 93274 (M) SUMMARY STATEMENT OF DEFICIENCIES ID PLAN OF CORRECTION (x5) pREle (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION TAG REGULATORY OR LSC IDENTIFYING INFORMATION) TAG TO THE APPROPRIATE DATE DEFICIENCY) A 049 Continued From page 5 A 049 designated area), to ensure Review of the 5/16/16 Medicai Staff Bylaws under Preamble section, documented that the Bylaws provided a framework for organization for the Medical Staff ?to discharge its responsibilities in matters involving the quality of medical care, to govern the orderly resolution of issues and the conduct ofthe Medical Staff functions supportive ofthose purposes, and to account to the Governing Body for the effective performance of Medical Staff responsibilities. The Medical Staff acknowledges that the Governing Body must act, directly or through its Manager, to protect the quality of medical care provided and the competency of the Medical Staff, and to ensure the responsible governance of the Hospital." Medical Staff responsibilities listed in Section 1.4.2 included: To establish and enforce, subject to the Governing Body approval, professional standards related to the delivery of health care within the Hospital. (9) To account to the Governing Body for the quality of patient care through regular reports and recommendations concerning the implementation, operation, and results of the quality review and evaluation activities. To initiate and pursue corrective action with respect to members where warranted." Section 10 described the organization of clinical services (which would include a surgery service) to be led by a service chief. Section 10.5.5 listed the roles and responsibilities for each service coverage is available when needed for OB deliveries and C-Sections. OB RN staff will be cross trained. The Peri-Operative Certification course 101 has been ordered and will provide the'necessary training for the OB nursing staff to provide surgical support for obstetric surgeries. In the meantime if surgical services are at maximum capacity and an inpatient and/or emergency obstetric patient presents to the emergency room, the obstetric patient will be transferred. This plan will continue to be in effect until a second surgical team and Anesthesiologist become available, which will occur no later than 3/9/17. - An OB emergency team of RN staff is currently being established to serve as a second OR team to support physicians for OB surgical cases. Plan for Improving: The Chief of Staff or designee from the MEC will report to the Governing Body all findings from monitoring all after hours surgical cases and cases for which a required surgical assistant was not present. Starting with 01/25/17 Board Meeting and 01/11/2017 MEC meeting this will surface as a regular standing agenda itejnlin the chief includingCoordinatIon and IntegratIon of InterserVIce (L. (m FORM Previous Versions Obsctete Event Facility ID: CA120001467 Wodr-ttinuatibn she?ijlaage '*1'1 1? ms: (- DEPARTMENT OF HEALTH AND l-iUlt/IAI" FOR MEDICARE MEDICAIL- PRINTED. 11/30/2016 FORM APPROVED OMB NO. 0938-0391 try: or 3m; il ?12,1101. I'i-l l< am; mu. sum/E 1-: . 7 1' .mer m1 PlAliUl tau/rim; our ll up 050359 ray/iris . 11/14/2016 NAME or STATE ZIPCODE 868 CHERRY AVENUE TULARE REGIONAL MEDICAL CENTER TULARE, CA 93274 IE, 1 SUMMARV or [JEFElEl/Cilis in . R's PLAN or CORRECTION (X5) pREFix ,1 (EACH. DEFICIENCV must BE PRFCEDED av PREF (EACH coRREciiVE Action SHOULD BE COMPLr-Irl'ari me i REeuwonoa IDENTIFVING CROSS-REFFRENCED TO THF APPROPRIATE DATE i TAG I . DEFICIENCY) A 049 Continued From page 6 and Intraservice services, I Development and implementation of policies and procedures that guide and support the provision of care, treatment, and services; Recommendations for a suf?cient number of quali?ed and competent persons to provide care, treatment. and services; 1 (I) Continuous assessment and improvement of the quality of care, treatment and services; i Maintenance of quality control programs, as i appropriate." I I Concurrent review of Medical Staff Peer Review Committee meeting minutes on 11/8/16 at 9:30 AM, with the Quality Manager I (QM) indicated that incidents for three patients (A, i B, and C) that occurred in 8/2016 and 9/2016, were referred for an outside peer review on 10/27/16. The QM stated that two of the i incidents involved delays in performing surgeries I and both patients died (A and B). Athird incident involved the retention of a foreign object following surgery, for which additional surgery was performed (Patient C). I Review of patient records indicated that Patient A needed urgent surgery to control suspected bleeding from the lower bowel (intestines), but the surgery on 8/22/16 was delayed by about 12 I hours for other urgent/emergent cases. Patient I B's urgent/emergent surgery for a bowel obstruction with infection and strangulation (the stoppage of blood ?ow) ofthe bowel on 9/16/16 was delayed by more than 9 hours due to other i emergent cases. Patient B's surgery was also interrupted and the surgical plan altered when the l? operating room team was needed for another emergent surgery. Patient C's complex surgery . to reconnect portions of bowel on 9/29/16 was A049 MEC. The Chief of Staffordesignee will i i present all resources available (refer to A I I 940) and a report of resources needed to the Governing Body. An alternative plan for surgical delays and failure to use surgical assistants when i required (A 940) has been put in place as of 11/09/16. Medical Staff will follow up with any Peer Review item which will be a standard review Procedure for Implementing: The Chief of Staff will directiy work with the CNO and each service chief of the affected areas. in addition, they will monitor that bi- reports are filed by MEC to the Governing Body. Monitoring Tracking: The MEC will monitor Plan of correction described in A 940 and report to the Governing Body. FORM Previous Versions Obsoiete Event. ID 71350911 f??acrlity It) CA120001467 If continuation sheet Page 7 of 51 DEPARTMENT OF HEALTH AND HUMAN CERVICES CENTERS FOR MEDICARE MEDICAID PRINTED: 11/30/2016 FORM APPROVED OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY STATEMENT OF DEFICIENCIES (x1) AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A BUILDING COMPLETED 050359 3- WING 11/14/2016 NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE 869 CHERRY AVENUE TULARE REGIONAL MEDICAL CENTER TULARE, CA 93274 (M) (D SUMMARY STATEMENT OF DEFICIENCIES ID PLAN OF CORRECTION (x5) pREle (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION TAG REGULATORY OR IDENTIFYING INFORMATION) TAG TO THE APPROPRIATE DATE DEFICIENCY) 'l A 049 Continued From page 7 A 049 and required additional operating room staff to position the patientPer IntervIews on 10/26/16, beginmng at 2 PM, ?3355 with Medical Doctor (MD) 6, the Operating Room 11;- Director (ORD) and Surgical Technician (ST) 1, I who was present at Patient C's surgery, toward .- the end of Patient C's case, operating room staff was called away to help with another emergent :11 surgery case, thereby causing distraction for the :22 instrument count and compromising the 53:1 - .- positioning which contributed to retention of a surgical device into Patient C's wound. In an interview on 11/8/16, at 9:30 AM, the OM stated that she created a root cause analysis to evaluate various decision points by all providers who had a hand in Patient B's care. However, no procedures to formally guide the decisions when surgical emergencies were lined up and delayed, to either transfer patients to another hospital or have second on?call teams immediately available, had been implemented. Regarding Patient C's incident, the OM indicated that the short-staf?ng aspect Of the incident was not discussed by medical staff or the quality committees. No referrals to other departments and/or groups to evaluate the impact of surgical staff shortages on patient safety resulted from this opportunity. In a review of the Performance Improvement (Pl) Committee materials (tracking of quality indicators and data), the QM acknowledged that formal tracking ofthe delays for surgical emergencies, shortage of OR (Operating Room) team support, transfers ofsurgical patients due to insuf?cient resources, or provider practice patterns were not captured by the Pl program. In an interview on 11/8/16 beginning at 11:15 AM, FORM Previous Versions Obsolete Event ID2705P11 Facility ID: CA120001467 If continuation sheet Page 8 of 51 DEPARTMENT OF HEALTH AND HUMAN CENTERS FOR MEDICARE a PRINTED 11/30/2016 FORM APPROVED QMB NO. 0938?0391 STATEMENT OF (X1) (X2) CONSTRUCTION (X3) DATE SURVEY the interim Operating Room Director (ORD) stated that for two years he had concerns for patient safety from complex surgical cases backing up emergent cases, mostly when one particular surgeon was on-call (MD 6). The hospital was a non-trauma, community hospital with only one on-call OR team (one anesthesiologist, one registered nurse, and one surgical technician) available afterhours (5 PM to 7 AM weekdays and all weekend hours). The strain on OR resources was frequently discussed at the ORD's internal weekly or steering committee meetings. The ORD also expressed these concerns at Surgery and Anesthesia Department meetings in 2015. Since January of 2016, the medical s'taffwas restructured and the ORD asked the current Surgery Committee Chair to address the concerns and bring the issue forward for solutions. However, formal meetings between the steering committee and the Surgery I Committee and/or the Surgery Committee Chair were often canceled and had not yet occurred. The ORD prepared a log to show patterns and I causes of delays for surgeries from 1/2016 to I 9/2016. The ORD provided the log to the hospital Chief Executive Of?cer in an appeal for more resources. The ORD indicated that solutions had i not been implemented, the same problems continued, and surgeries for urgent and emergent patients were still at times delayed. In some cases, errors were made and patient outcomes suffered. The Surgery Committee Chair was the same surgeon (MD 6) who drove many ofthe incidents about which the ORD was concerned. In an interview on 11/1/16 at 2:30 PM, MD 9, an anesthesiologist and past Surgery Committee Chair prior to 1/2016, indicated that concerns 1 about strains on the on-call operating room AND PLAN OF CORRECTION IDENTIFICATION NUMBER A COMPLETED 050359 3- 11/14/2016 NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE 869 CHERRY AVENUE TULARE REGEONAL MEDICAL CENTER TU LARE, CA 93274 (x4) ID SUMMARY STATEMENT OF ID PROVIDERS PLAN OF CORRECTION (x5) PREFIX (EACH DEFICIENCY MUST BE PRECED-ED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION TAG REGULATORY OR LSC IDENTIFYING INFORMATION) TAG CROSSFREFERENCED TO THE APPROPRIATE DATE I A 049 Continued From page 8 A 049i FORM Previous Versions Obsolete Event ID. 7D5P11 Facility ID: CA120001467 lf continuation sheet Page 9 of 51 DEPARTMENT OF HEALTH AND HUMAN CENTERS FOR MEDICARE 8: MEDICAID PRINTED: 11/30/2016 FORM APPROVED OMB NO. 0938-0391 resources and delays in surgeries were discussed by the Surgery Committee in 2015. MD 9 stated that he requested the hospital administration to address how the surgical resources were utilized, but no solutions were enacted. MD 9 stated that he observed a preference for MD 6 to perform surgeries late in the day and at night, including cases that could be scheduled early in the day when three OR teams were available. To date, no efforts had changed MD 6's practice pattern of arranging for surgeries late in the day when resources were stretched thin. Review of the OR Delay Log from 1/14/16 to 9/21/16 indicated that more than most other surgeons, surgical patients assigned to MD 6 experienced frequent delays of2-4 hours, with comments that MD 6 had worked the previous night and was too tired to start cases at several scheduled times prior to 1 PM. MD 6 was also I delayed from car problems and health issues. I After hours cases done by MD 6 occurred on 1/19/16, 1/20/16, 2/23/16, 3/18/16, 3/29/16, 4/13/16, 4/15/16 (which included a 6 hour delay), 4/18/16, 4/22/16, 4/25/16, 5/2/16, 7/8/16, 8/22/16 (which included Patient A's 12 hour delay), 8/24/16 (which included a 7 hour delay), and MD 6 also rescheduled cases to a Saturday (when only one on-call OR team was available) on two occasions, 3/25/16 and 7/8/16. Review of Medical Executive Committee (MEC, the highest level of Medical Staffleadership) minutes, dated 11/5/15, documented under Obstetric (the branch of medicine and surgery concerned with childbirth and the care of women giving birth) Committee Report, "There needs to 9/16/16 (which included Patient 8'5 9 hour delay). I I I STATEMENT OF DEFICIENCIES (x1) (x2) MULTIPLE CONSTRUCTION (x3) DATE SURVEY AND PLAN OF CORRECTION IDENTIFICATION NUMBER. COMPLETED A. BUILDING 050359 8- WING 11/14/2016 NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE ZIP CODE 869 CHERRYAVENUE TULARE REGIONAL MEDICAL CENTER TULARE, CA 93274 (M) ID SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDERS PLAN OF CORRECTION (st PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL (EACH CORRECTIVE ACTION SHOULD BE COMPLETION TAG REGULATORY OR LSC IDENTIFYING INFORMATION) TAG CROSS-REFERENCED TO THE APPROPRIATE DATE DEFICIENCY) . I A 049 ContInued From page 9 A 049 I FORM Previous Versions Obsolete Event Facility iD: CA120001467 If continuation sheet Page 10 of 51 DEPARTMENT OF HEALTH AND HUMAN PRINTED: 11/30/2016 FORM APPROVED CENTERS FOR . OMB NO. 0938?0391 STATEMENT OF (x1) (x2) MULTIPLE CONSTRUCTION (x3) DATE SURVEY AND PLAN OF CORRECTION IDENTIFICATION NUMBER: COMPLETED A, BUILDING 050359 BVWING 11/14/2016 NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, STATE, ZIP CODE 869 CHERRYAVENUE TULARE REGIONAL MEDICAL CENTER TU LARE, CA 93274 (x4) ID SUMMARY STATEMENT OF DEFICIENCIES TD PROVIDERS PLAN OF CORRECTION 3 (X5) (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE i COMPLETION TAG REGULATORY OR LSC INFORMATION) TAG . TO THE APPROPRIATE I DATE . DEFICIENCY) A 049 Continued From page 10 A 049 be full back?up coverage for emergency cases a?er hours. Currently after 4:30 pm. no cases can be scheduled and should a patient come in that needs to have an emergency c-section [also known as a Caesarean section - a surgical procedure used to deliver a baby through incisions into the mother's abdomen] there can be a three or four hour wait to arrange for a back?up surgical team to be available. However, it has been noted that there are non-emergent cases that are being allowed to take place afterhours and on weekends." The MEC recommended that Administration assure full coverage for emergency cases afterhours and on weekends. "Currently there is only a skeleton crew for emergency cases, which puts patients at risk." Review of the hospital's GB meeting minutes dated 1/26/16 documented a motion to terminate the hospital's relationship with its Medical Staff and adopt an arrangement with a new medical staff association comprised ofvirtually identical members but with different leadership designees. Review of the MEC minutes from the new leadership starting 1/2016 showed no documented discussion of delays in surgeries, impact on staff and patients, and over-utilization ofthe single on?call OR team until the 9/14/16 meeting. "Have been discussing with administration regarding having 2 surgeries simultaneously." "Great safety issue with not being able to provide two surgical crews at the same time (Referring to Emergency Cases)." The MEC minutes noted considerations for hiring additional surgical technicians, anesthesia providers, and a trained surgical assistant; but no discussion for evaluating the procedures for accepting surgical cases late in the day and FORM Previous Versions Obsolete Event ID: 7D5P11 Facility 10: CA120001467 If continuation sheet Page 11 of51 OF "ercES FOR MEDICARE: sari-11cm PRINTED. 11/30/2013 FORM APPROVED OMB NO. 0938?0391 3'0" Ul' ANI) I Ft'iil?/ ION 050359 ITI 111"? it) I'iliill HAITI I ?1 ElelI 11/14/2016 . A :lLl'l'NG NAME OF PROVIDER OR SUPPLIER TULARE REGIONAL MEDICAL CENTER S'l REET STATE ZIP CODE 869 CHERRY AVENUE TULARE, CA 93274 (X4110 STATEMENT OF DEFICIENCIES pREf??lx (EACH DEFICIENCY MUST BE PRECEDED BY MG 1 REGULATORY OR IN FORMATIONI PLAN OF I (EACH CORRECTIVE ACIION SHOULD BE COMPLETION CROSS-REFERENCE.) I 0 THE APPROPRIAIE DATE DEFICIENCY) A 049 Continued From page 11 afterhours, recruiting additional surgeons to share call, when to transfer surgical patients, or how to address the practice patterns of a surgeon who was largely driving the incidents behind these I concerns (MD 6). No formal Recommendations orActions were documented from the discussmn. Minutes from the 10/12/16 MEC meeting noted I approval of the 8/17/16 Surgery Committee and 9/12/16 Obstetric Committee reports; but no I further discussions or solutions related to delays in surgeries or the competing needs of afterhours I surgical patients were declared. Similarly, no discussions or solutions related to delays in surgeries or the competing needs of afterhours surgical patients were documented In the GB minutes in all of 2015 and 2016 (through 10/11/16). Review of Medical Staff policies and procedures effective since 1/26/16, showed no to revise the organization of surgical services and provision of resources to meet the identi?ed needs of surgical patients. Review of Medical Staff policies, rules and bylaws . showed no formal listing of the surgical procedures that required a surgical assistant. No policies set expectations for surgical practices to conform with nationally recognized organizational standards (erg, procedures requiring a surgical assistant). in an interview on 11/8/16 at 11:30 AM, the 0RD stated that sometime in the past such a list existed but that he and anesthesia staff were unable to locate it. A263 482.21 QAPI The hospital must develop. implement and Tag A 263 I Finding I Person/s) Responsible: Quality Director or designee, CNO, CEO, I 01/31/17 1 FORM PreVIous Versrons Obsolete Event ID 7D5P11 Facilit:y ID: If continuation sheet Page 12 of 51 PRINTED: 11/30/2016 FORM APPROVED OMB NO. 0938-0391 DEPARTMENT OF HEALTH AND HUMAN CENTERS FOR MEDICARE 8. MEDICAIL RVI CES _i-tVI CES maintain an effective, ongoing, hospital-wide, data-driven quality assessment and performance improvement program. The hospital's governing body must ensure that the program re?ects the complexity of the hospital's organization and services; invoives all hospital departments and services (including those services furnished under contract or arrangement); and focuses on indicators related to improved health outcomes and the prevention and reduction of medical errors. The hospital must maintain and demonstrate evidence of its QAPI program for review by CMS. This CONDITION is not met as evidenced by: Based on staffinterview and record review, the hospital failed to ensure an effective Quality Assurance and Performance Improvement (QAPI) program in place to protect the safety of its patients when: 1. The hospital's Governing Body (GB) did not specify the detail and frequency ofdata collection for its program [Refer to 2. The hospital failed to correct the long-standing issues on Operating Room (OR) coverage which contributed to serious compiications and patient deaths; failed to impiement corrective actions and mechanisms after tracking and analyzing STATEMENT OF DEFICIENCIES (x1) (x2) MULTIPLE CONSTRUCTION (x3) DATE SURVEY AND PLAN OF CORRECTION IDENTIFICATION NUMBER: COMPLETED . A. BUILDING 050359 8- WING 1111412016 NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE 869 CHERRY AVENUE TULARE REGIONAL MEDICAL CENTER TULARE, CA 93274 (x4) .9 SUMMARY STATEMENT OF DEFICIENCIES TD PLAN OF CORRECTION (x5) pREFrx (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX I (EACH CORRECTIVE ACTION SHOULD BE COMPLETION TAG REGULATORY OR IDENTIFYING INFORMATION) TAG CROSS-REFERENCED TO THE APPROPRIATE DATE DEFICIENCY) A263 Continued From page 12 A263 MEC, Governing Body Plan for Correcting: A Performance Improvement Patient Safety (PIPS) report will detail QAPI projects and will be presented to the Governing Body at least bi? beginning 01/31/17. Pian for Improving: QAPI improvement projects will be reported quarterly to the Governing Body, documenting in the Governing Body?s minutes the rationales for the selected projects. Procedure for Impiementing: All PIPS report and QAPI projects will be presented to MEC, and quarterly to the Governing Body Monitoring Tracking: A performance improvement report will be reviewed monthiy at the PIPS Committee Meeting as well as a quarterly Patient Safety Report. The MEC and Governing Body minutes will re?ect the QAPI program highlighting pertinent details of this report. Measurable progress achieved on the projects will be tracked by the PIPS committee and reported to the MEC and Governing Body. Finding #2 Person 5 Res onsible: QUality Director or designee, CNO, CEO, MEC, Governing Body adverse patient events, and continued to put its Plan for Correcting: 3.12;; patients' at risk for untoward outcomes [Refer to Refer to Tag A 940 A 941 fig-1"} Plan for Improving: 54$? 3. The hospital failed to document the reasons rnit? j, . . . . Cit-?1 why certain quality Improvement prOJects are mm FORM Previous Versions Obsolete Event EDJ7DSP11 Facility ID: Egr?'qtinuat?n sheet Page 13 of 51 5235 1 1130/2016 .: .: OHM APPROVED (JEN FOR MEDICARE 8; IVIIEDICAIIJ xvii-LES OMB NC). 0938-U5EJI ft (112; i tuft-ll Iz(El ?:le - II I) 050359 11/14/2016 NAME OF PROVIDER UR SUPPLIER STHEF I ADDRESS (II-Z STATE ZIP CUBE 369 CHERRY AVENUE TULARE REGIONAL MEDICAL CENTER TULARE, CA 93274 (X4) SUMMARY STATEMENT OF DEFICIENCIES II) I PROVIDERS PLAN OI- I (X5) PREFIX I DEF ICIENCV MUST BE PRECEDED BY FULI. I PREFIX (EACH IVE IQN SHOULD HE (LTHVIPIETIOH TAG i RE OR LSC IDENTIITVING TAG I CROSS-REFERENCED TO THE APPROPRIATF i . DEFICIENCY) A263 Continued From page 12 maintain an effective, ongoing, hospital-wide, data-driven quality assessment and performance improvement program. A 253 Refer to Tag A 940 8L A 941 Procedure for Implementing: Refer to Tag A 940 A 941 Monitoring 8t Tracking: Refer Finding #3 I PersonIs) Responsible: 01/31/17 The hospital's governing body must ensure that I the program re?ects the complexity of the hospital's organization and services; involves all hospital departments and services (Including those services furnished under contract or Quality Director or designee, CNO, CEO, I MEC, Governing Body arrangement), and focuses on indicators related mg: I to improved health outcomes and the prevention Per POIICV 10'1017-7 Identification 0f . and reduction of medical errors. potential safety issues will be identified I through a review of Quality Management The hospital must maintain and demonstrate Review System (QMRS) which will consist evrdence of its QAPI program for review by CMS of: Quality Review Reports, CMS Quality . Indicators such as Core Measures, results . and findings from regulatory agencies This is not met as eVIdenced by: and/or accrediting agencies, Infection I Based on staffinterVIew and record reVIew, the Control gap analysis and other I hospital failed to ensure an effective Quality departmental areas where mandatory Assurance and Performance improvement I . . . I reporting [5 reqUIred. I Plan for Improving: All criteria identified through the QMRS will i . . I 1. The hospital's Governing Body (GB) did not I be rewewed, analyzed and'discussed I specify the detail and frequency ofdata collection I In the PIPS Committee. areas I . for its QAPI program [Refer to I identified for process improvement will be i i (QAPI) program in place to protect the safety of its patients when: monitored by the PIPS Committee and 2. The hospital failed to correct the long-standing followed by each of the applicable issues on Operating Room (OR) coverage which department directors for measurable contributed to serious complications and patient improvement. deaths; failed to implement corrective actions Procedure for Implementing: adverse patient events, and continued to put its the PIPS Committee will be measured, patients' at risk for untoward outcomes [Refer to I analyzed, and tracked by the I Quality Management Committee. . . . I and mechanisms after tracking and I All criteria identified through the QMRS in i I 3. The hospitai failed to document the reasons why certain quality improvement projects are FORM Prewous Versions Obsolete Event ID Facility ID. CA12000146T If continuation sheet Page 13 of 51 Page of 51 OI: HEALTH AND CENTERS FOR PRINTED OMB NU 0958?0591 IUAT ON NUUHIJI Uncu- 050359 A B'Jll. I ll writs DA (Stiff-:1! rLl) 11/14/2016 NAME PROVIDER OR SUPPI IER TULARE REGIONAL MEDICAL CENTER ADDRESS CIIY SYN I l? CODE 869 CHERRY AVENUE TULARE, CA 93274 to Improved health outcomes and the prevention I and reduction of medical errors. I The hospital must maintain and demonstrate I evidence of its program for review by CMS. This CONDITION is not met as evidenced by: Based on staff interview and record review, the hospital failed to ensure an effective Quality Assurance and Performance Improvement (QAPI) program in place to protect the safety of its patients when: 1, The hospital's Governing Body (GB) did not specify the detail and frequency ofdata collection for its QAPI program [Refer to 2. The hospital failed to correct the long-standing issues on Operating Room (OR) coverage which contributed to serious complications and patient I deaths; failed to implement corrective actions and mechanisms after tracking and analyzing . adverse patient events, and continued to put its patients' at risk for untoward outcomes [Refer to 3. The hospital failed to document the reasons why certain quality improvement projects are 1x4)?; I SUMMARY or In PLAN OF CORRECTION mg. mp; IX (EACH DEFICIENCY MUST BE PRESEDET) BY r??uu. l?RFl-?lr' (EACH CORRECTIVE ACT ION SHOULD BE. namrm- Is-s mp, REGULATORY OR INFORMATION) CROSS REFERENCED TO THE APPROPRIATE WE- I i A 263 Continued From page 12 A263 Monitoring Tracking: I maintain an effective, ongoing. hospital?Wide) All areas identified for process I data-driven quality assessment and performance I I improvement will be monitored by the PIPS I I Improvement program. I I Committee and followed by each of the I department directors for measurable . . I . The hospital 5 governing body must ensure that I improvement. the program reflects the complexrty of the hos ital's or anization and services involves all . . l3 I 1 I Finding #4 hospital departments and serVIces (Including rson 5 Res onsible 01/31/17 . . I I those serVIces furnished under contract or . CEO I arrangement): and focuses on indicators related I Plan for Correcting: i Annually the CEO will work with the I Governing Body to approve a budget which I provides adequate financial resources for Surgical Services to have an appropriate level of provider and nurse staffing at all times. Quarterly the CEO or designee will monitor the level of resources needed in Surgical Services and report to the Governing Body on this issue as appropriate and to ensure that resources are being allocated as indicated in A940. I Governing Body will provide a forum in their regular board meeting for MEC to I report surgical operational issues as discussed further in section A 940. This will further ensure that the plan stated In A 940 is adhered to and that the standard hours of operations are adhered to. mg: I Refer to the response in A 940. I Procedure for Implementilm: Refer to the response in A940. Plan of correction was implemented on 11/09/16. I FORM Prevrous Versions Obsolete Event Facility ID CA120001467 If continuation sheet Page 13 of 51 Page 13?8 of 51 OF AND CENTERS FOR MEDICARE 8: MEDICAID l?[4le ED 11/30/2016 I- ORM APPROVED OMB NO. 0938?0391 cl J/ai lit u?ll A .llmir ?rm-rum 'nun wwill ?l.l rrill 050359 1111442016 NAME OF PROVIDER OR TULARE REGIONAL MEDICAL CENTER Cl'lY STATE ZIP com: 369 CHERRY AVENUE TULARE. CA 93274 I COLLECTION ANALYSIS Program Scope (1) The program must include, but not be limited 1 to, an ongoing program that shows measurable improvement in indicators for which there is evidence that it will improve health outcomes (2) The hospital must measure, analyze, and track quality indicators and other aspects of performance that assess processes of care, hospital service and operations. II (b)Program Data (x4; ID SUMMARY STATEMENT Ol- ID PROVIDERS Ol- LJORRE (mom MI PRlairlx (extol I ERECEDGD BY PREFIX suour L) BE me i Ream/?may OR INFORMATION) me APPROPRIATE DAIE DEFICIENCY) I i A 263 Continued From page 13 Monitorj?gil'ra?g: being conducted. and the measurable progress Quarterly the CEO will monitor the level of achieved on the projects [Refer to resources needed in Surgical Services and report to the Governing Body on this issue 4 The hospital?s GB, Medical Staff, and as appropriate and to ensure that administrative of?cials failed to ensure that I resources are being allocated as indicated patient safety were not compromised, when in A940. issues of OR coverage and faulty physicran I practice pattern were identi?ed but not corrected; and the hospital did not provide evidence of approval of the GB on its formal QAPI programs, I to have clearly written policy and procedures and budgeted resources -- approved by the GB after I input from the Chief Executive Of?cer and I medical staff leadership [Refer to I These failures resulted in the hospital's inability to I ensure the provision of quality health care in a I safe environment, due to lack of optimal and I I timely surgical care. I The cumulative effect of these systemic failures I I resulted in the inability of the hospital to comply with the statutorily-mandated Conditions of Tag A 273 I Participation for QAPI. Finding #1 01/31/17 A 273 DATA A273 Person(s) Responsible: MEC, Governing Body Plan for Correcting: PIPS report detailing Governing Body reviewed QAPI projects will follow the PDSA (Plan, Do, Study, Act) model to measure, analyze, and track quality indicators specific to safety of services and quality of care to ensure measurable improvement in indicators identified as i i Quality Director or designee, CNO, CEO, Obsolete Event ID Facrlity ID. CA120001467 If continuation sheet Page 14 of 51 OF AND RVICES l-?Rll?xlTED' 11/30/2016 FORM APPROVED CENTERS FOR 8: l?v?lEDiC/nh BABE-5 NO. 0938-10391 {Ht/\i 01? I ll: 1114.1.? 111' 1' Rial-?11 iraiv (IV-J) 1.1151le: Amr. PLAN 01- NUMBER A WNW - corvipLi-?iL-n 050359 1111412016 NAME or orz SUPPLTEH Ct 7.113120111- ses CHERRY AVENUE TULARE REGIONAL MEDICAL CENTER TULARE, CA 93274 014, ID SUMMARY STATEMENT or lD pRovipER's PLAN or CORRECTION PREFEX MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACT iOlv? SHOULD BE COMPLETION TAG REGULATORY ca IFYING TAG CROSS-REFERENCED TO DATE DEFICIENCY) . . A273 Continued From Page 14 A 273 areas for improvement through the QMRS. (1) The program must incorporate quality indicator data including patient care data, and other relevant data, for example, information submitted to, or received from, the hospital's Quality Improvement Organization. (2) The hospital must use the data collected to-- (I) Monitor the effectiveness and safety of services and quaiity of care; and (3) The frequency and detail of data collection I must be speci?ed by the hospital's governing ?body. This STANDARD is not met as eVIdenced by: Based on staff interview and document review, the hospital's Governing Body (GB) failed to specify the detail and frequency of data collection for its Quality Assurance and Performance Improvement (QAPI) programs, in accordance with GB Bylaws. This had the potential to not enable the GB to provide a clear overview and oversight for its QAPI programs. Findings: 1 1. A concurrent staff interview and document review was conducted with the Quality Manager (QM) on 11/10/16. between 10:45 AM and 1:35 PM. The Quality improvement project binders, quality committee meeting minutes, board meeting minutes, GB Bylaws, hospital's policy on serious clinical adverse event and internal audit policy were reviewed. The QM showed multiple quality indicators that were tracked by various departments When the surveyor asked to see the 68's approval for these projects with Plan for lmgroving: Areas of improvement identified by the organization?s program and reviewed by the Governing Body will develop, review, and analyze all quality indicators, event reports, and FMEA. All identified areas of opportunity for improvement will be highlighted and discussed in the Committee beginning January 2017. Areas of improvement will have a clearly identified plan of correction documented in for measurable improvement beginningJanuary 2017. Procedure for Implementing: All criteria identified through the QMRS in the Committee will be measured, analyzed, and tracked Monitoringgi Tracking: All areas identified for process improvement will be monitored by the Committee and followed by each of the department directors for measurable improvement. Finding #2 Personls) Responsible: CNO and COO . Plan for Correcting: I The CNO and COO will work with the Quality Director or designee to develop, review, and anaiyze a dashboard which shows the patient safety program metrics. This dashboard will be presented to the 01/31/17 FORM OMS-2567(02-991Prewous Versrons Obsolete Event ID Faculity lD: CA120001467 lf'contlnuation sheet Page 15 of 51 OF l-IEAIjl'l AND FORM APPROVED CENTERS FOR ti l'viEtJlCAlL OIVIB NO 0938?0391 OI: W: if- AND PLAN OI- ION liltilill l< A 050359 ll WNG 1111412016 NAME OF PROVIDER OR IFR CITY ZIP CODE 869 CHERRY AVENUE TULARE REGIONAL MEDICAL CENTER TULARE, CA 93274 W, STATEMENT OF ll) i PROVIDERS PLAN OF CORRECTION m5) (EACH MUST PRECEDED BY FULL I (EACH CORRECTIVE ACTION SHOULD BE COMPLETION REGULATORY OR IDENTIFYING INFORMATION) I me CROSSREFERENCED To THE APPROPRIATE I DATE 1 . DEFICIENCY) i i A273 ContInued From page 15 A273 Governing Body. i speci?cations of instruction on data collection, the OM was not able to prOVIde such evidence. When asked, "Do you have formal approval of your projects by Governing Body?" QM replied, . Subsequent reVIew of the quality management system review meeting minutes, dated in 10/2016, indicated that the hospital plan was to reduce the departmental quality objectives from ?ve to three, and set specific goals for each project. However, there were no specmcs about how often each project will collect data and details for the data collection. 2. A concurrent staff interview and document I review was conducted with the Chief Nursing Of?cer (CNO) on 11/10/16, between 1:35 PM and 3 PM. The CNO was able to demonstrate a poster on a project that was completed in 2015, called the "Provider in Triage" project. The project carried out a baseline study which showed that the rate of patient "Left without being seen in the Emergency Department (ED) was 12-14%, and it decreased to 4% during the intervention period when a second Physician Assistant was added to the provider in the ED for 5 days a week When asked, "Have your Governing Body approved this project?" The CNO replied, "Not formally." When asked whether there was any written evidence that this project was discussed at a board meeting, the CNO stated, Review ofthe hospital's GB Bylaws, adopted 5/2013, indicated in Article V, Section 4, "Hospital Committees", that Performance Improvement Committee's primary purpose "is to provide oversight of the [hospitalj's performance Plan for Improving: The Quality Director or designee will work in conjunction with the CNO to evaluate the quality of patient care, identify/ resolve patient care problems, and identify opportunities to improve patient care in accordance with Governing Body Bylaws. m9?edure A report outlining development, review and analysis ofthe Performance i Improvement Program will be presented to the Governing Body. Monitoring Tracking: A performance improvement report will be reviewed at the PIPS Committee I I Meeting as well as a quarterly Patient I Safety Report. The MEC and Governing Body minutes will reflect the QAPI program highlighting pertinent details of this report. FORM Prevtous Versions Obsolete Event ID 7D5P11 Facility lD' CA120001467 If continuation sheet Page 16 of Pl?tllil?l'ED FORM APPROVED CENTERS FOR 8: MEDICAII. OMB NO. 09380th cx', PR5.- Irma. A w, ll' conquer-?Iron min/CI. suwsv ANIIPI ION A - ?50359 '3 WNGM- 11/14/2016 NAME or PROVIDER OR SUPPIIEH s'rRr-Et ADDRESS CIrv STATE 2IP CODE ass CHERRY AVENUE TULARE REGIONAL MEDICAL CENTER TULARE, CA 83274 M, Io 1 SUMMARY STATE MENT or ID PLAN or CORRECTION Ixs. (EACH DEFICIENCY MUST BE PRECEDEC BY EULI IEACI-I CORRECT IVE ACTION SHOULD BE TAG I REGULATORY OR IDENTIFVING W3 CROSS-REFERENCED to THE APPROPRIATE: DATE I I DEFICIENCV) . A273 I Continued From page 16 A 273 improvement activities, and to establish a . consistent, systematic approach to improving organization wide improvement. A summary of I . Performance Improvement activities is to be 1 submitted to the Board on periodic basis, but not I less than semi-annually." A 286 PATIENT SAFETY A286I Tag A 286 Standard: Program Scope Finding #1 I 01/31/17 I (1) The program must include, but not be limited to, an ongoing program that shows measurable I improvement in indicators for which there is I evidence that It will identify and reduce I medical errors. I (2) The hospital must measure, analyze, and track .. adverse patient events Program Activities (2) Performance improvement activities must track medical errors and adverse patient events, analyze their causes, and implement preventive actions and mechanisms that include feedback I and learning throughout the hospital. I Executive Responsibilities, The hospital's i governing body (or organized group or individuat . who assumes full legal authority and responsibility I for operations of the hospital), medical staff, and administrative of?cials are responsible and I accountable for ensuring the following: (3) That clear expectations for safety are established. I This STANDARD is not met as evidenced by: Based on interviews and document reviews, the Person 5 Res onsible: Quality Director or designee, CNO, CEO, MEC, Governing Body Plan for Correcting: The Patient Safety Program will utilize the information obtained from adverse everts, serious clinical adverse events, sentinel events, external governing agencies, Pharmacy and Therapeutics, Medication Error Reduction (MERP) Program, Infection Control, Electronic Event Reporting system, Blood Product Use, and Mortality Review to identify processes that could potentially pose high risk to patient safety. When such processes are identi?ed, they will be presented to the Governing Body. Plan for Improving: I The Quality Director, CNO, CEO (or designee) and MEC will establish performance measures to address those processes that have been identified as high risk to patient safety. Quality Director or designee will provide a Performance Improvement Patient Safety (PIPS) report update to the Governing Board. Procedure for Implementing: FORM Previous Versrorts Obsolete Event ID Facility CA120001467 If continuation sheet Page 17 of 51 OF HEAL Tl PRINTED: 11/302016 FORM APPROVED CENTERS FOR 63?; lt?li?DlCAit OMB NO. 09138-1591 I a mo Ir're-r LIA I.1 l' S?Zr'l 1:311. ?ii/R coma omn- A I 050359 WP 11/14/2016 NAME or PROVIDER OR srREETAotiRre'ss (HTV, sir/(TI: zmcour; 869 CHERRY AVENUE TULARE REGIONAL MEDICAL CENTER TULARE, CA 93274 014/ (D STATEMENT or If.) PROVIDERS PLAN or- CORRECTION (x5, TEACH MUST BE PRECEDED BY PRU-IX i CORREC I ACTION SHOULD BE (AG REGULATORY 0R IDENTIFYING my; DTO THE APPROPRIATE WE i A286 Continued From page 17 A286 hospital failed to implement corrective actions and mechanisms after tracking and analyzing patient adverse events; failed to correct the issues on Operating Room (OR) coverage which I contributed to several serious complications, including patient deaths, in three of six patient records reviewed (A, B, and C) [refer to A-940, i and continued to put its patients at risk for untoward medical outcomes. These failures contributed to several serious complications, including patient deaths, and continued to put its patients' at risk for untoward medical outcomes Findings: i Concurrent review of medical staff peer review committee meeting minutes on 11/8/16, at 9:30 AM, WIth the Quality Manager (QM) Indicated that incidents for three patients (A, B, and C) that occurred in August and September of 2016, were referred for an outside peer review I on 10/27/16. The QM stated that two of the incidents involved delays in performing surgeries and both patients died (A and B). Athird incident involved the retention of a foreign object followrng surgery, for which additional surgery was performed (Patient C). Review of patient records indicated that Patient A needed urgent surgery to control suspected bleeding from the lower bowel (intestines), but the surgery on 8/22/16 was delayed by about 12 . hours for other urgent/emergent cases. Patient B's urgent/emergent surgery for a bowel obstruction with infection and strangulation (stoppage of blood flow) ofthe bowel on 9/16/16 was delayed by more than 9 hours due to other The hospital has approved the Serious Clinical Adverse Event Policy that specifies the actions and mechanisms in responding to all serious clinical events. A case debrief and root cause analysis (RCA) will be conducted on a case by case basis. A Failure Modes Effects Analysis (FMEA) will be conducted yearly as well as ongorng staff training, reorientation, coaching for all . other patient safety events. Physicians who are involved with patient safety events are I identified and put through an internal . medical staff process. Monitoring 8: Tracking: performance measurement data will be coliected, aggregated, and analyzed to determine if opportunities to improve safety and reduce risk are identified. If so, these processes which demonstrate significant variation from desired practice will be prioritized and necessary resources will be allocated to mitigate the risks identified. 01/31/17 Finding #2 3 WOW: Quality Director or designee, CNO, CEO, MEC, Governing Body I Plan for Correcting: The Patient Safety Program will utilize the information obtained from adverse everts, serious clinical adverse events, sentinel events, external governing agencies, . Pharmacy and Therapeutics, Medication I I I I Error Reduction (MERP) Program, Infection I FORM PreVIous VBFSIOITS Obsolete Event Factlity lD: If continuation sheet Page 18 of 51 -. DEPAR or AND "mores F214 CENT eRs MEDICARE a OMB no. 093 30/2016 ROVED 8039.1 emergent cases. Patient B's surgery was also interrupted and the surgical plan altered when the operating room team was needed for another emergent surgery Patient C's complex surgery I to reconnect portions of bowel on 9/29/16 was and required additional operating room staffto position the patient. Per interviews on 10/26/16 at 2 PM, with Medical Doctor (MD) 8, the Operating Room Director (ORD) and Surgical Technician (ST) 1 who was present at Patient C's I surgery, toward the end of Patient C's case, operating room staff was called away to help with another emergent surgery case, thereby causing I distraction for the instrument count and compromising the positioning which contributed to retention of a surgical device into Patient C's I wound, In an interview on 11/8/16 at 9:30 AM, the OM stated that she created a root cause analysis to evaluate various decision points by all providers who had a hand in Patient B's care. However, no procedures to formally guide the decisions when surgical emergencies were lined up and delayed, to either transfer patients to another hospital or have second on-call teams immediately available, had been implemented. Regarding Patient C's incident, the QM indicated that the short~staf?ng aspect ofthe incident was not discussed by medical staff or quality committees. No referrals to other departments and/or groups to evaluate the impact of surgical staff shortages on patient I safety resulted from this opportunity. In a review of the Performance Improvement (Pl) Committee materials (tracking ofquality indicators and data), the QM acknowledged that formal tracking ofthe I delays for surgical emergencies, shortage of OR team support, transfers ofsurgical patients due to . insuf?cient resources, or provider practice Blood Product Use, and Mortality Review identify processes that could potentially i pose high risk to patient safety. When such processes are identi?ed, they will be presented to the Governing Body. Plan for Improving: Quality Director or designee will provide a Performance Improvement Patient Safety (PIPS) report quarterly to the Governing I Board. Procedure for Implementing: The hospital has approved the Serious Clinical Adverse Event Policy that specifies the actions and mechanisms in responding to all serious clinical adverse events. A case I debrief and RCA will be conducted on a case by case basis. A Failure Modes Effects Analysis (FMEA) will be conducted yearly as I well as ongoing staff training, reorientation, coaching for all other patient safety events. Physicians who are involved with patient safety events are identified and put through an internal peer review process. Monitoring Tracking: A performance measurement data set will be collected, aggregated, and analyzed to determine if opportunities to I improve safety and reduce risk are identified. If so, those processes which demonstrate significant variation from desired practice will be prioritized and necessary resources will be allocated to mitigate the risks identified. . ?-t'leMUJ' or (7.2., li-iIJI. :IrLi; ion m: liAiI; snR/Lv NJI I?lNlI?Dunning 050359 WNG .E 11/14/2016 NAME or PROVIDER OR SUPPLIER L'AooREss. cirv STATE ZIP com. 869 CHERRY AVENUE TULARE REGIONAL MEDICAL CENTER TULARE. CA 33274 cm IL) SUMMARY sm?remurn Oi: to PLAN or CORRECTION as, PREFIX (EACH DEFICIENCY MUST BE av FULL (EACH CORRECTIVE ACTION SHOULD BE I TAG REGULATORY OR Iomrirvwc TAG CROSS-REFERENCE) TO I WE DEFICIENCY: . A286 Continued From page 18 A286 Control, Electronic. Event Reporting system, FORM VerSIons Obsolete Event ID.705P11 ID: If continuation sheet Page 19 of 51 DEPARTMENT OF HEALTH AND HUMAN CENTERS FOR MEDICARE 8: MEDICAID PRINTED: 11/30/2016 FORM APPROVED OMB NO. 0933:0391 STATEMENT OF DEFICIENCIES (X1) (X2) MULTIPLE CON STRU CT (X3) DATE SURVEY patterns were not captured by the Pl program. in an interview on 11/8/16 beginning at 11:15 AM, the interim Operating Room Director (ORD) stated that fortwo years he had concerns for patient safety from complex surgical cases backing up emergent cases, mostly when one particular surgeon was on?cail (MD 6). The hospital was a nonutrauma, community hospital with only one on?call OR team (one anesthesiologist, one registered nurse, and one surgical technician) available afterhours (5 PM to 7 AM weekdays and all weekend hours). The strain on OR resources was frequently discussed at the internal weekly or steering committee meetings. The ORD also expressed these concerns at Surgery and Anesthesia Department meetings in 2015. Since January of 2016, the medical staff was restructured and the ORD asked the current Surgery Committee Chair to address the concerns and bring the issue forward for solutions. HOWever, the ORD stated that the formal meetings between the steering committee and the Surgery Committee and/or the Surgery Committee Chair were often canceled and had not yet occurred. The ORD prepared a log to show patterns and causes of delays for surgeries from 1/2016 to 9/2016. The ORD provided the log to the hospital Chief Executive Of?cer in an appeal for more resources. The ORD indicated that solutions had not been implemented, the same problems continued, and surgeries for urgent and emergent patients were still at times delayed. In some cases, errors were made and patient outcomes suffered. The Surgery Committee Chair was the same surgeon (MD 6) who drove many of the incidents about which the ORD was concerned. AND LAN OF CORRE TION IDENTIFICATION NUMBER A BUILDING COMPLETED 050359 '3 WWG- - 11/14/2016 NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE 869 CHERRY AVENUE TULARE REGIONAL MEDICAL CENTER TULARE, CA 93274 (x4) ID SUMMARY STATEMENT OF DEFICIENCEES ID PROVIDERS PLAN OF CORRECTION (x5) (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION TAG REGULATORY OR LSC INFORMATION) TAC CROSS-REFERENCED TO THE APPROPRIATE DATE DEFICIENCY) A 286 Continued From page 19 A286I FORM PreVIous Versions Obsolete Event ID17D5P11 Facility ID: CA120001467 If continuation sheet Page 20 of-51 DEPARTMENT OF HEALTH AND HUMAN 9" CENTERS FOR MEDICA MEDICAID .I PRINTED: 11/30/2016 FORM APPROVED OMB NO. 0938-0381 STATEMENT OF DEFICIENCIES (x1) (x2) MULTIPLE CONSTRUCTION 1'st DATE SURVEY AND PLAN OF CORRECTION IDENTIFICATION NUMBER: COMPLETED A BUILDING 7 050359 11/14/2016 NAME OF PROVIDER OR SUPPLIER TULARE REGIONAL MEDICAL CENTER STREET ADDRESS, CITY, STATE, ZIP CODE 869 CHERRY AVENUE TULARE, CA 93274 In an interview on 11/1/16 at 2:30 PM, MD 9, an anesthesiologist and past Surgery Committee Chair prior to 1/2016, indicated that concerns about strains on the on-call operating room resources and delays in surgeries were discussed by the Surgery Committee'in 2015, MD 9 stated that he requested the hospital administration to address how the surgical resources were utilized, but no solutions were enacted. MD 9 stated that he observed a I preference for MD 6 to perform surgeries late in the day and at night, including cases that could be scheduled early in the day when three OR teams were available. To date, no efforts had changed MD 6's practice pattern of arranging for surgeries late in the day when resources were stretched thin. I Review of the OR Delay Log from 1/14/16 to I 9/21/16, indicated that more than most other surgeons, surgical patients assigned to MD 6 experienced frequent delays of2?4 hours, with I comments that MD 6 had worked the previous night and was too tired to start cases at several I scheduled times prior to 1 PM. MD 6 was also delayed from car problems and health issues. After hours cases done by MD 6 occurred on 1/19/16, 1/20/16, 2/23/16, 3/18/16, 3/29/16, '4/13/16, 4/15/16 (which included a 6 hour delay), 4/18/16, 4/22/16, 4/25/16, 5/2/16, 7/8/16, 8/22/16 (which included PatientA's 12 hour delay), 8/24/16 (which included a 7 hour delay), and I MD 6 also rescheduled cases to a Saturday (when only one on-call OR team was available) on two occasions, 3/25/16 and 7/8/16. Review of the Medical Executive Committee (MEC, the highest level of medical staff 9/16/16 (which Included Patient 8'5 9 hour delay). 0(4) ID SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDERS PLAN OF CORRECTION 5 )3ngle (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION TAG REGULATORY OR IDENTIFYING INFORMATION) TAG CROSS-REFERENCED To THE APPROPRIATE I DATE DEFICIENCY286 Continued From page 20 A2861 FORM Previous Versions Obsolete Event ID: 7D5P11 Factlitle; CA120001467 If continuation sheet Page 21 of 51 PRINTED: 11/30/2016 DEPARTMENT OF HEALTH AND HUMAN VICES FORM APPROVED CENTERS FOR MEDICARE 8: MEDICAID OIVIB NO. 0938?0391 STATEMENT OF DEFICIENCIES (X1) (x2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY AND PLAN OF CORRECTION IDENTIFICATION .. BUILDENG COMPLETED ULIJI. II 050359 . 3- 11/14/2 01 5 NAME OF PROVIDER OR SUPPLIER I. Jail 2 7 CITY, STATE. ZIP CODE 869 CHERRY AVENUE TULARE REGIONAL MEDICAL CENTER - -- . .. ?be 93274 (x4) ID SUMMARY STATEMENT OF DEFICIENCIES iD I PROVIDERS PLAN OF CORRECTION (st (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION TAG REGULATORY OR LSC IDENTIFYING INFORMATION) TAG CROSS-REFERENCED TO THE APPROPRIATE DATE DEFICIENCY) A286 Continued From page 21 A 286 leadership) minutes dated 11/5/15, documented under Obstetric (the branch of medicine and surgery concerned with Childbirth and the care of women giving birth) Committee Report, "There needs to be full back-up coverage for emergency cases after hours. Currently after 4:30 PM no cases can be scheduled and should a patient come in that needs to have an emergency Cesarean section [also known as a C?section, a surgical procedure used to deliver a baby through incisions in the mother?s abdomen] there it can be a three or four hour wait to arrange for back-up surgical team to be available. However, it has been noted that there are nonnemergent cases that are being allowed to take place afterhours and on weekends.? The MEC recommended that Administration assure full coverage for emergency cases afterhours and on weekends. ?Currently there is only a skeleton crew for emergency cases, which puts patients at risk. Review of the hospital?s Governing Body (GB) meeting minutes dated 1/26/16 documented a motion to terminate the hospital's relationship with its Medical Staff and adopt an arrangement with a new Medical Staff association comprised of virtually identical members but with different leadership designees. Review of the MEC minutes from the new leadership starting 1/2016, showed no documented discussion ofdelays in surgeries, impact on staff and patients, and over-utilization ofthe single 0n-call OR team until the 9/14/16 meeting. "Have been discussing with administration regarding having 2 surgeries simultaneously." "Great safety issue with not being able to provide two surgical crews at the same time (Referring to Emergency Cases).? 1 FORM Previous Versions Obsolete Event ID7YDSP11 Facility ED: CA120001467 If continuation sheet Page 22 of 51 1175012016 OF AND FORM APPROVED FOR MEDICARE e?s. hex/Ices OMB NO. 09380391 '3 CF ill"; UL I: It..I-.l A 013) AMI) Pl AN OI CORRHJI ION A IEIIJILI 050359 . ., 11/14/2015 NAME OF PROVIDER OR SLIPPI. IITR TULARE REGIONAL MEDICAL CENTER STREEI ADI IRESS TY STATE, WP ()OfilE 869 CHERRYAVENUE TULARE, CA 33274 SUMMARY STATEMENT OF (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGUIJITORY OR IDENTIFYING (X4) IU PREFIX 1AG ID PREFIX I PROVIDERS PLAN OF CORRECTION I :st I (EACH CORRECT IVE ACTION SHOULD BE cur-mm mm CROSS-REFERENCE) TO THE APPROPRIATE DATE I DEFICIENCY) A286 Continued From page 22 I The MEC minutes noted conSIderations for hiring additional surgical technicians anesthesia providers, and a trained surgical assistant; but no discussion for evaluating the procedures for accepting surgical cases late in the day and afterhours, recrUIting additional surgeons to share . call, when to transfer surgical patients, or how to I address the practice patterns of a surgeon who was largely driving the incidents behind these concerns (MD 6). No formal Recommendations or Actions were documented from the discussion. Minutes from the 10/12/16 MEC meeting noted approval of the 8/17/16 Surgery Committee and 9/12/16 Obstetric Committee reports; but no further discussions or solutions related to delays in surgeries or the competing needs of afterhours I surgical patients were declared. I Similarly, no discussions or solutions related to I delays in surgeries or the competing needs of afterhours surgical patients were documented in I the GB minutes in all of 2015 and 2016 (through 10/11/16). Review of medical staff policies and procedures effective since 1/26/16 showed no to revise the organization of surgical services and provision of resources to meet the identi?ed needs of surgical patients. A297 482.21(d) QAPI PERFORMANCE I IMPROVEMENT PROJECTS As part of its quality assessment and performance improvement program, the hospital must conduct performance improvement projects. I (1) The number and scope ofdistinct improvement projects conducted annually must be proportional to the scope and complexity of the I A297 Tag A 297 Finding #4 We: The following have been identified as the QAPI projects; 1. Emergency Department Left Without Being Seen (LWBS). 2. Increase patient satisfaction scores. 3. 30?day readmission rates. 4. 12/2016 FORM Vers?Ions Obsolete Event ID 7D5F311 II: ID. CA120001467 If continuation sheet Page 23 of 51 OF HEAL. AND HUMAN [glil'xl'l'ERS EOR MEDICARE PRINTED: 11/30/2015 FORM APPROVED UMB NO. 0938?0391 "ii/tit. ?146' Eli-l ifilFFt'C'l?f?r :11. 7951' E3- L-L'ir'i. {111.337 Ch 131 hospital's services and operations. (2) A hospital may, as one of its projects, develop and implement an information technology system explicitly designed to improve patient safety and quality of care. This project, in its initial stage of development, does not need to demonstrate measurable improvement In indicators related to health outcomes. (3) The hospital must document what quality improvement projects are being conducted, the reasons for conducting these projects, and the measurable progress achieved on these projects. (4) A hospital is not required to participate in a QIO cooperative project, but its own projects are required to be of comparable effort. I This STANDARD is not met as evidenced by: Based on staff interview and document review, the hospital failed to document the reasons why certain quality improvement projects are being conducted and the measurable progress achieved on the projects. This failure had the potential to not enable the hospital to clearly recognize the impact of the Quality Assurance and Performance Improvement (QAPI) project on health care quaiity and effectively monitor its progress. Findings: A concurrent staff interview and document review was conducted with the Chief Nursing Of?cer (CNO) on 11/10/16, between 1:35 PM and 3 PM. The CNO was able to demonstrate a poster about a QAPI project that was completed in 2015, the "Provider in Triage" project. The project carried out a baseline study which showed that AND PI AN or criRRi?r?ron il'leLNI'l NUMBER ., A litiv?a (3 050359 "5 11/14/2015 NAME OF PROVIDER DR SUPPLIER STAT z:r> com: 869 CHERRY AVENUE TULARE REGIONAL MEDICAL CENTER TULARE, CA 93274 ID SUMMARY STATEMENT or ID PROVIDER's PLAN OF (x5, PREHX (EACH must BE PREOEDED av FULL PREFIX (EACH IVE ACTION SHOULD BE COMPLETION TAG REGULATORY OR LSC IN FORMATION) TAG CROSS-REFERENCED TO THE APPROPRIATE DATE DEFICIENCY) I 1 A 297 Continued From page 23 A 297 Review urgent, emergent surgical cases, level 1-4, for appropriateness of care. Plan for Improving: The QIVI RS committee identified the LWBS, 1 Increase patient satisfaction scores, 30-day readmission rates and review of urgent, emergent surgical cases, level 1-4, for appropriateness of care as areas for improvement. Subcommittees have been established and will be meeting at least (starting February 2017) to prioritize goals and establish a process to meet the objectives (reduce left without being seen, increase patient satisfaction, reduce 30-day readmission rates and all surgical cases level 1-4 meet the i appropriateness of care). The QMRS meets quarterly to review the progress ofthese subcommittees. The results of the quarterly meetings will be reported to the medical staff, senior leadership and I Governing Body quarterly. Procedure for Implementing: interdisciplinary subcommittees meet to identify process and identify the ability to gather, review and analyze the data from CMS as well as build an internal electronic system of data collection. The organization has also converted to a full I electronic health record in an effort to I meet these goals and to track measurable improvement indicators. Monitoring Tracking: I The organization has converted to an I across the organization integrated 02/2017 FORM Prevrous Obsolete Event ID Facility CA120001467 if continuation sheet Page 24 of 51 OF AND avrces $415111 r-Rs FOR a; erct?s PRINTED 11/30/2016 FORM APPROVED OMB NO. 0938-0391 LITIES The hospital's governing body (or organized group or individual who assumes full legal authority and responsibility for operations of the hospital), medical staff, and administrative of?cials are responsible and accountable for ensuring the following: I i 1) That an ongoing program for quality improvement and patient safety, including the reduction of medical errors, is de?ned, implemented, and maintained . (2) That the hospital-wide quality assessment and performance improvement efforts address priorities for improved quality of care and patient safety and that all improvement actions are evaluated. (5) That the determination of the number of I distinct improvement projects is conducted . annually. shut-trill! or nt-i 'x1, 112,117.13 ll 1' man/.11. sanity Arii. PLAN or NilMisi-?R A . ?50359 ?3 11/14/2016 NAME or OR suniJnt-iR AonREss cw SiATli some 869 CHERRY AVENUE TULARE REGIONAL MEDICAL CENTER TULARE, CA 93274 1x41 11 SUMMARY STATEMENT Ol- ID PLAN or CORRECTION (x5) PREFTX (EACH must BE PRECE i- PREHX . (EACH CORRECTIVE ION SHOULD BE CUMPLETIUN mg i REGULATORY OR i. so IFYING TAG ORoss REFERENCED TOTHE APPROPRIATE 1 A 297 Continued From page 24 A 297 electronic health record that will provide a the rate of patient "Left without being seen new set of data tools to meet the goals and in Emergency Department (ED) was objectives. 12-14%, and it decreased to 4% during the I intervention period when a second Physician . Assistant was added to the provider in the ED for i 5 days in a week. The CNO stated that in her presentation to the leadership team for the hospital, the leadership was aware that . decreasing the rate of LWBS was bene?cial for the quality of health care. When asked whether she can provide formal documentation of the I reasons why this proiect was chosen. and what the goal and expectations were, the GNU stated i 1 "There were no written explanation of the i project". The CNO further stated that these questions were not formally addressed. A309 I QAPI . A 309 Tag A 309 Finding #1 #2 Personls) Responsible: Quality Director or designee, CNO, COO, CEO, MEC, Governing Body Plan for Correcting: The CEO, COO, CNO, and Quality Director, in collaboration with the medical staff, and other members of the management team, will develop a hospital-wide quality assessment and performance improvement (QAPI) program to address priorities for improved quality of care, patient safety, . and reduction in medical errors. They will utilize the information obtained from adverse events, serious clinical 02/28/17 FORM Versaons Obsotete Event lD 705911 Facility lD. 2000146? If continuation sheet Page 25 of 5" ENT OF HEALTH AND CENTERS FOR lv?II- Ifx?itJ/iilij PRINTED 11/30/2016 FORM APPROVED UIVIB NU. 0938-0391 ?I??'l'l?ifli' i?i l?i'l EHHLI Null 11 NJ Ii 1): Hill ll,( Iii/T . IAIL obit-ti 1 "I?ll A 050359 WIND 11/14/2016 NAME or SUPPI IEH (.2ITV ZIP CODE 869 CHERRY AVENUE TULARE REGIONAL MEDICAL CENTER TULARE, CA 93274 rx4I In SUMMARY or DEFICIENCIES ID PROVIDERS PLAN or Ixs. IIREHX oer MUST HILL I (EACII CORRECTIVE ACI ION SHOULD or. TAG REGULATORY DEFICIENCYContinued From page 25 A 309 adverse events, sentinel events, external i governing agencies, Pharmacy and Therapeutics, Medication Error Reduction I I (MERP) Program, Infection Control, Th's STANDARD '5 not met as eVIdenced W- Electronic Event Reporting system, Blood . I?ashed stagintervIean: ff I Product Use, and Mortality Review. This 08m? F?V?emm me 'Ca 5 a 7 QAPI will be presented to and discussed and admInIstratIve of?CIaIs faIIed to ensureWIth the Body. I accordance WIth GB bylaws. that patient safety I Pl 1? I . . were not compromised, after Issues of Operating w?p?ng. . . . Room (OR) coverage and physician Quaiity Director or deSIgnee prowde a practice pattern were identi?ed; and the hospital Performance Improvement Patient Safety did not provide eVIdence of approval of the GB on (PIPS) report b'?m0?thl?/ to the Governing its formal Quality Assurance and Performance Improvement (QAPI) programs; to have clearly Procedure for Implementing: written policy and procedures, budgeted The hospital has approved the Serious resources, and clearly identified responsible Clinical Adverse Event Policy that specifies staffhapproved by the GB after input from the the actions and mechanisms in responding Chief Executive Of?cer (CEO) 30d medical Staff to all serious clinical adverse events. A case leadership. debrief and RCA will be conducted on a I I I case by case basis. A Failure Modes Effects I These contrIquteIzI to the cIchIqurrencIes of Analysis (FMEA) will be conducted yearly as I severa comp Ica IonIs, Inc Ing pa Ien well as ongoing staff training, reorientation, I deaths; continued to put patients at rIsk for . . coachIng for all other patIent safety events. untoward health care outcomepotential to not enable the hospItaI carry out its are WI patIent I QAPI program with adequate planning and sa ety events are 'dentl {Ed and Wt i resources to ensure the success ofthe programs through an Internal medlcal staff peer and the quality of health care provided by the process. hospital. Monitoring Tracking: I On a basis, Performance 02/28/17 Findings: - measurement data will be collected, 1. Concurrent review of medical staff peer review committee meeting minutes on 11/8/16. at 9:30 AM, with the Quality Manager (QM) indicated that incidents for three patients (A, B, and C) that occurred in 8/2016 and 9/2016 were referred for an outside peer review on 10/27/16. The QM stated that two of the aggregated, and analyzed to determine if opportunities to improve safety and reduce risk are identified. When such opportunities are identified, or when processes demonstrate significant variation FORM OMS-256710299) Prewous Versions Obsolete Event ID Facility 10 If continuation sheet IPage 26 of 51 l3?l'illxl'lED: 11/30/2016 DEPAP TM 'r or HE/tl ji AND HUM/xiv FORM APPROVE-D FUR iv?lEDlCi?ilTiE 5; lv'lEDlCAiiJ OMB NU. 0938~039'l ?ilNHt?l?/i Ii Iii-l Ir?; :Izriim'i. ".Lllt?flfi' -riu