QUALITY MANUAL. For Advocate Health Care Quality Management System (QMS) Approved: 07/17/2015 Revision: 4.0

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1 Exhibit OO17.1 Advocate BroMenn Medical Center QUALITY MANUAL For Advocate Health Care Quality Management System (QMS) Approved: 07/17/2015 Revision: 4.0 This Quality Manual provides an overview of the Quality Management System for Advocate Health Care. It is maintained in compliance with the policy for Document Control. Printed copies of this manual are uncontrolled. Exhibit OO17.1 Advocate BroMenn Medical Center 1

2 Scope and Exclusions Scope: Geographically located in Illinois, Advocate Health Care is a faith based healthcare system with community and teaching hospitals, including ten acute care hospitals, one critical access hospital and one integrated Children's hospital. Care is also provided in a variety of ambulatory settings, including outpatient centers and clinics operationally supported by three Support Centers. Labs at Advocate Health Care maintain College of American Pathologists (CAP) accreditation certificates. The extensive range of health care services provided by Advocate Health Care include Acute Medical, Surgical, Critical Care, Cardiac, Rehabilitative, Occupational Health, Obstetrical, Pediatric, Emergency Care, Laboratory Services, Radiology Services, Behavioral Health (at select locations), as well as additional services that are offered at specific sites. This Quality Manual provides guidance in coordination with the Advocate Integrated Quality and Patient Safety Plan which is established on an annual basis. ISO 9001:2008 Quality Management System Requirements Advocate Health Care develops, implements, and maintains an ongoing system for managing quality in accordance with ISO 9001:2008 and has established (6) ISO policies in conjunction with this Quality Manual which include: Document Control Control of Records Quality Management System (QMS) Audits Control of Nonconforming Product Corrective Action for Continual Improvement Preventive Action Exclusions and Necessary Justifications: Exclusion 7.3: Advocate Health Care has determined an exclusion for design of product based upon Advocate Health Care using only proven methods, treatments, equipment and medications. Advocate Health Care also does not participate in development of new methods, treatments, equipment and medications. Quality Policy The Advocate Health Care quality policy is: Safety, Quality, and Service Always Through Continual Improvement. The leadership and associates of Advocate Health Care execute our quality policy through our quality management system and a commitment to continual improvement to enhance patient safety, health outcomes, operational excellence, and patient satisfaction. Quality and Patient Safety Plans are maintained by the sites to provide operational framework. Advocate s quality policy encompasses our philosophy and framework in addition to our performance measurement system which includes our Key Result Areas. Revision 4: 08/03/2015 1

3 Philosophy and Framework Mission Statement: The mission of Advocate Health Care is to serve the health needs of individuals, families and communities through a wholistic philosophy rooted in our fundamental understanding of human beings as created in the image of God. Vision Statement: The vision of Advocate Health Care is to be a faith-based system providing the safest environment and best health outcomes while building lifelong relationships with the people we serve. The Advocate Experience: Advocate lives our Mission, Values and Philosophy (MVP) through the Advocate Experience, with our commitment to create the safest and best place for our patients, associates and physicians always. The Advocate Experience is: An experience without harm Safety An experience of excellence Quality An experience of engagement and trust Service Always Values The Statement of Values of Advocate Health Care serves as an internal compass to guide our relationships and actions: Compassion We embrace the whole person and respond to emotional, ethical and spiritual concerns, as well as physical needs in our commitment to unselfishly care for others. Equality We affirm the worth and spiritual freedom of each person and treat all people with respect, integrity and dignity. Excellence We empower people to continually improve the outcomes of our service, to advance quality and to increase innovation and openness to new ideas. Partnership We collaborate as employees, physicians, volunteers and community leaders to utilize the talents and creativity of all persons. Stewardship We are responsible and accountable to all that we are, have and do. Revision 4: 08/03/2015 2

4 Philosophy The Philosophy of Advocate Health Care is grounded in the principles of human ecology, faith and community-based health care. These principles arise from an understanding of human beings as whole persons in light of their relationship to God, themselves, their families and the society in which they live. Through our actions we affirm these principles. We believe each person is created in the image of God. We respect, include and serve people without regard to race, religion, age, disability, gender, sexual orientation or socio-economic status. We seek to assure the spiritual freedom of all persons. We extend our concern for the whole person to our patients, employees, physicians, volunteers, trustees and their families. We address clinical, business, corporate and social-ethical issues from a faith perspective and assist individuals, families and professionals in the resolution of these issues. We are guided by the principles of justice in addressing our social responsibility as a corporate citizen in this society. We are responsible and accountable in the spirit of stewardship for all the resources under our management to assure the accomplishment of our Mission. We believe in effective collaboration with those individuals and entities interested in addressing the health care needs of our region. Revision 4: 08/03/2015 3

5 The table below offers a profile summary for the hospitals within Advocate Health Care. HOSPITAL PROFILE SUMMARY Rehabilitation Graduate Neonatal Services Licensed Offsite Medical Trauma Intensive Care Accreditation Additional Hospital Location Beds Locations Education Center Level (NICU) by CARF Accreditations Acute Care Hospitals: Advocate BroMenn Medical Center Advocate Christ Medical Center Advocate Condell Medical Center Advocate Good Samaritan Hospital Advocate Good Shepherd Hospital Advocate Illinois Masonic Medical Center Normal, IL Level II Level II Chest Pain Center Accreditation Center Certification ANCC as Magnet nursing hospital Advanced Heart Failure Certification Comprehensive Stroke Center Level IIIc Certification (Children s Ventricular Assist Oak Lawn, IL Level I Hospital) Device Certification Chest Pain Center Accreditation Libertyville, IL Level I Level II+ Center Certification ANCC as Magnet nursing hospital Chest Pain Center Accreditation 2010 Malcolm Baldrige National Quality Award Downers Grove, IL Level I Level III Center Certification ANCC as Magnet Nursing hospital Center Certification Chest Pain Center Barrington, IL Level II Level - IIe Accreditation ANCC as Magnet nursing hospital Chicago, IL Level I Level III Center Certification Advocate Lutheran General ANCC as Magnet Hospital Level III nursing hospital (Children s Park Ridge, IL Level I Hospital) Center Certification Advocate South Suburban Hospital Hazel Crest, IL Level - IIe Center Accreditation Advocate Sherman Hospital ANCC as Magnet nursing hospital Center Certification Chest Pain Center Advocate Trinity Hospital Critical Access Hospital: Advocate Eureka Hospital Eureka, IL 25 - Elgin, IL Level-11 Level - IIe Accreditation Chicago, IL Level - IIe Center Certification Children s Hospital: Advocate Children s Hospital Oak Lawn Oak Lawn, IL Level IIIc Park Ridge Park Ridge, IL Level I Level III Revision 4: 08/03/2015 4

6 Key: CARF = Commission on Accreditation of Rehabilitation Facilities ANCC = American Nursing Credentialing Center = YES Acute Care Hospitals: Advocate BroMenn Medical Center (ABMC) In addition to the main campus, ABMC operates four off campus locations including: Advocate BroMenn Outpatient Center, Normal, IL - providing women s imaging, therapy, and laboratory services Advocate BroMenn Adult Day Services, Normal, IL- providing life enrichment services for aging adults along with assistance and respite for caregivers Wound Healing Center, Normal, IL - providing outpatient hyperbaric treatment and care of patients with chronic wounds Family Health Clinic, Normal, IL - providing outpatient family medicine services Advocate Christ Medical Center (ACMC) In addition to the main campus, ACMC operates five off-campus locations including: Advocate Christ Center for Breast Care, Oak Lawn, IL providing diagnostic breast health studies and dexascan Advocate Christ Medical Center Outpatient Center, Tinley Park, IL - providing services for sleep disorders and rehabilitation High Tech Park, Palos Heights, IL, providing Cardiac Rehabilitation Services Advocate Christ Medical Center Outpatient Center, Lockport, IL- providing services for rehabilitation, diagnostic imaging, cardiodiagnostics, pain management and sleep studies Advocate Christ Medical Center Outpatient Center. Palos Heights, IL providing sleep lab Advocate Condell Medical Center In addition to the main campus, Advocate Condell Medical Center operates nine offsite locations, including: Advocate Condell Imaging Center, Gurnee, IL providing imaging services, such as open MRI, ultrasound, CT Scan, general X-ray, and mammography screening to facilitate a patient s diagnosis and treatment Advocate Condell Immediate Care Center, Gurnee, IL The Advocate Gurnee Condell Immediate Care Center services include treatment for minor illnesses and injuries and in-house X-ray and laboratory services to facilitate diagnosis and Revision 4: 08/03/2015 5

7 treatment. The center also performs screenings, physicals and occupational health services Advocate Condell Immediate Care Center, Round Lake, IL Services includes treatment for minor illnesses and injuries and in-house X-ray and laboratory services to facilitate diagnosis and treatment. This center also performs screenings, physicals and occupational health services Advocate Condell Immediate Care Center, Vernon Hills, IL Services include treatment for minor illnesses and injuries and in-house X-ray and laboratory services to facilitate diagnosis and treatment. This center also performs screenings, physicals and occupational health services Centre Club, Gurnee, IL - providing outpatient rehab services Centre Club, Libertyville, IL - providing outpatient rehab services Physical Therapy Clinic, Grayslake, IL - providing outpatient rehab services Advocate Condell Medical Center Lincolnshire Rehab/Complete Orthopedic care, Lincolnshire, IL providing outpatient rehab services Advocate Condell Physical Therapy, Vernon Hills, IL providing outpatient rehab services Advocate Good Samaritan Hospital (AGSH) In addition to the main campus, AGSH operates three off campus locations and one location on campus but physically separate from the hospital, including: Advocate Good Samaritan Outpatient Center, Downers Grove, IL - providing immediate care, physical therapy, diagnostic imaging and laboratory services Advocate Good Samaritan Outpatient Center, Lemont, IL- providing immediate care, physical therapy, diagnostic imaging and laboratory services Advocate Good Samaritan Imaging Center, Woodridge, IL - providing diagnostic imaging services Good Samaritan Health & Wellness Center, Downers Grove, IL, providing outpatient physical therapy services in a 90,000 square foot medical model fitness center located on the campus of Good Samaritan Hospital Advocate Good Shepherd Hospital In addition to the main campus, the following comprise the locations of clinical care provided by Advocate Good Shepherd Hospital: Advocate Good Shepherd Hospital Sleep Lab Center, Barrington, IL providing diagnostic and therapeutic sleep testing Advocate Good Shepherd Immediate Care Center, Crystal Lake, IL providing immediate care, diagnostic imaging and laboratory services Advocate Good Shepherd Outpatient Center, Lake Zurich, IL providing diagnostic imaging and pediatric only rehabilitation Revision 4: 08/03/2015 6

8 Advocate Good Shepherd Hospital Health and Fitness Center, Barrington, IL providing outpatient physical and occupational therapy for adult s including Lymph edema, Aquatic and Hand Therapy services in a 69,000 square ft. medical model fitness center located off campus Advocate Good Shepherd Outpatient Center, Algonquin, IL providing diagnostic imaging and Pediatric Cardiac Clinical Echo 2D services Advocate Good Shepherd Outpatient Center, Crystal Lake IL providing pediatric physical, occupational and speech therapy and physical therapy for adults including Lymph edema Advocate Good Shepherd Diabetes Center, Barrington, IL providing comprehensive assessment and education for individuals with Type 1, 2 and Gestational Diabetes Advocate Good Shepherd Radiation Oncology, Barrington, IL providing single beam radiation therapy Advocate Illinois Masonic Medical Center (AIMMC) In addition to the main campus, AIMMC has eight offsite locations: Antenatal Resource Center, Chicago, IL providing Ultrasound, Fetal Assessment, Prenatal Diagnosis, Fetal Echocardiography, Genetic Counseling and Maternal- Fetal Medicine Consultation Health and Wellness Clinic, Chicago IL - a pharmacist-managed clinic currently providing anticoagulation and lipid management and smoking cessation services Chicago Anesthesia Pain Specialists/Pain Center, Chicago, IL providing advanced treatments for a wide variety of acute and chronic conditions, including patient education specific to personal pain management Creticos Cancer Center, Chicago, IL providing individualized, comprehensive, leading edge cancer care Infusion Center, Chicago, IL providing Intravenous, Intramuscular and Subcutaneous Medication treatment Outpatient Diagnostic Center, Chicago, IL providing imaging services for general x-ray, CT, MRI, PET and Stress testing Women s Imaging Center, Chicago, IL providing Women s imaging services in Mammography and Ultrasound Behavioral Health Services (Outpatient), Chicago, IL providing individual, group and family therapy, substance abuse treatment, and psychiatric services for adults and children Advocate Lutheran General Hospital (ALGH) In addition to the main campus, ALGH has four off site locations including: Center for Advanced Care featuring the leading edge Cancer Care Center, Center for Advanced Imaging and the Richard G. and Carol Caldwell Breast Center, Park Ridge, IL providing full range of advancements in cancer treatment, state of the art radiation therapy, advanced imaging capabilities that allow for accurate Revision 4: 08/03/2015 7

9 screening evaluation and diagnosis of illness and injuries including x-ray, Cat scan, MRI, nuclear medicine, PET and ultrasound, digital mammography including 3D tomosynthesis screening Center for Advanced Care featuring the Behavioral Health Adult Day Program providing behavioral health services for adults 18 and above with mood and anxiety disorders, focusing on cognitive behavioral therapy Patient Resource Center featuring advanced wound care, Niles, IL providing Advanced Wound Care through an interdisciplinary model including physical therapy, advanced practice nursing, and physicians Patient Resource Center featuring anticoagulation management, Niles, IL providing assistance to physicians in the monitoring and management of patients receiving anticoagulant therapy, ongoing patient assessment, changes in therapy and maintaining communication with providers, and patient and provider education Older Adult Services, Des Plaines, IL providing a medical model Adult Day Service, Home delivered meals, senior information and resources, emergency response systems and expressions at early Alzheimer s program as well as outpatient rehabilitation services Advocate Sherman Hospital In addition to the main campus, Advocate Sherman Hospital operates eleven offsite locations including: Advocate Cardiac Rehab, Elgin, IL - provides comprehensive services involving medical evaluation, prescribed exercise, risk-factor modification through education counseling and behavioral intervention Advocate Sherman Imaging, Elgin, IL - provides imaging services, MRI, digital mammography, general diagnostic and breast ultrasound, angiograph, body and joint CT, general nuclear medicine and nuclear cardiology, cardiac (Echo) ultrasound Advocate Sherman Outpatient Center, Algonquin, IL provides immediate care services, occupational health, physical therapy, outpatient lab and medical imaging including CT, ultrasound and mammography Advocate Sherman Outpatient Center, Elgin, IL provides immediate care services, occupational health, physical therapy, outpatient lab and medical imaging including CT and ultrasound Advocate Sherman Outpatient Center, South Elgin, IL - provides immediate care services, occupational health, physical therapy, outpatient lab and medical imaging including CT, ultrasound and mammography Anticoagulant clinics in Elgin and Algonquin IL - provide consultative services for INR monitoring by a pharmacist with oversight by a cardiologist and pathologist Advocate Sherman Park Place, Streamwood, IL - provides physical therapy services including aquatic therapy Advocate Sherman Physical Therapy at the Elgin Centre, Elgin, IL - provides physical therapy services Revision 4: 08/03/2015 8

10 Advocate Sherman Diabetes Center at the Elgin Centre, Elgin, IL provides education in the self-management of diabetes and related conditions, offering ongoing follow-up and support to the patients and families Center street campus, Elgin, IL includes a Center for Sleep Disorder providing comprehensive sleep studies; and, Advocate Sherman Center for Occupational Rehab and Evaluation (SCORE) sees patients by appointment only providing functional capacity evaluations and various pre-work screenings Advocate South Suburban Hospital In addition to the main campus, Advocate South Suburban Hospital operates one off campus sleep center: South Suburban Hospital Sleep Center, Tinley Park, IL providing treatment for sleep disorders Advocate Trinity Hospital (ATH) In addition to the main campus, ATH operates two off campus locations including: Advocate Trinity Hospital Sleep Lab, Chicago, IL providing treatment for sleep disorders Advocate Trinity Hospital Wound Care Center, Chicago, IL- providing treatment for non-healing wounds Advocate Children s Hospital Advocate Children s Hospital, Oak Lawn, IL In addition to the main campus, Advocate Children s Hospital in Oak Lawn operates 6 off-campus locations including: Advocate Children s Hospital - Oak Lawn, IL providing outpatient pediatric therapy services Advocate Children s Hospital - Oak Lawn, IL providing consultative therapy services to ACH Pediatric Specialty Clinics in addition to individualized diagnostic/therapy services of Audiology, Speech, Physical and Occupational Therapies Advocate Christ Medical Center Outpatient Center, Lockport, IL providing pediatric physical, occupational and speech therapy services Ambulatory Clinics Advocate Children s Hospital Oak Lawn - Providing outpatient primary care including a wide array of integrated specialty services Advocate Children s Hospital-Oak Lawn, IL, Keyser Family Pediatric Cancer Center-providing individualized services to children with cancer and hematologic disease Revision 4: 08/03/2015 9

11 Advocate Children s Hospital- Park Ridge Attached to the main campus, Advocate Children s Hospital in Park Ridge operates: Yacktman Children's Pavilion (Outpatient Services) Park Ridge, IL providing a comprehensive range of pediatric outpatient services from pediatric primary care and subspecialties, to diagnostics and therapies Critical Access Hospital: Advocate Eureka Hospital (AEH) No offsite campuses Advocate Health System Clinical, Support, and Business Services Overview The following narrative overviews support the diagram entitled Advocate Health Care Process Map on the page that follows. Advocate Health System Clinical Services The clinical services offered by the hospitals in Advocate Health Care share three common clinical processes. The process begins when the patient is admitted or accesses the hospital clinical services. The patient then enters the diagnosis/treat phase. In this phase there are several clinical and ancillary or diagnostic services. Some of these services vary by hospital but all hospitals offer the services shown on the process map. Once the patient completes the diagnostic and treat phase, they are discharged or transitioned. The discharge/transition process is addressed throughout the entire patient stay. If transitioned, patients may transition to home or another facility. Advocate Health System Support Services The Advocate support services provide service and material support to the clinical services and the organization as a whole. The support services processes that occur either at the system or site level include fiscal, ancillary, general, human resources, clinical transformation and contracted services. The contracted services vary by site. Advocate Health System Management The Advocate Health Care Board of Directors oversees the business management functions of the Advocate System. There is two way communication and interaction between the Board and Advocate system senior leadership and the site Governing Councils. The system ISO 9001 Quality Management Review Committee interacts and is accountable to these two groups. The Medical Executive Committees at each hospital report to the site Governing Councils. Revision 4: 08/03/

12 Safety, Quality, Service: The Advocate Experience Advocate Process Map Leadership Oriented Processes Governing Council Administration/ Medical Staff Business Development Strategic Planning Charitible Foundation Marketing Finance Legal & Ethics Oversight MVP ACCESS DIAGNOSE/ TREAT TRANSITION Patient Oriented Processes Key Work System Inpatient Care Key Work System Emergency Care Key Work System Outpatient Care Labor and Delivery Nursery Post Partum Med/Surg Pediatrics Tele Critical Care Behavioral Health Transition of Care Home Home Health/ Hospice Skilled Nursing/ Rehab Long Term Acute Care Hospital Patient Oriented Support Processes Patient Access Mission & Spiritual Care Surgical & Procedural Services Ambulatory Clinic Imaging Nutrition Laboratory Pharmacy Respiratory CV Services Wound Care Rehab/ Therapy Services Care Management Community and Wellness Support Processes Information Systems Supply Chain Quality/Risk/ Safety Innovation Guest Services/ Patient Relations Research Education Security Contracted Services Human Resources Revenue Cycle Biomedical Engineering HIM Medical Staff Services EVS Facilities Infection Prevention 2/9/2015 Revision 4: 08/03/

13 Quality Management Oversight Committee Structure Quality Manual Advocate Health Care Board of Directors System ISO 9001 Quality Management Oversight Committee (Sr. Leadership Team) Site Governing Councils Site Executive Team Site ISO 9001 Quality Management Oversight Committee * BroMenn * Christ * Condell * Eureka * Good Samaritan * Good Shepherd * Illinois Masonic * Lutheran General * Sherman * South Suburban * Trinity Reporting Exchange Medical Executive Committee (MEC) Revision 4: 08/03/

14 Advocate Health Performance Measurement System Key Result Areas (KRA s) are established to support strategic objectives; measures are established to monitor the performance for each KRA. Accountability for performance is addressed through an objective leadership evaluation system in which management performance objectives directly align to KRA performance. Performance improvement initiatives are driven by performance gaps as measured by KRA s and opportunities identified by leadership. The KRA s and the Performance Measurement System is illustrated in the diagrams below. Key Result Areas (KRA) Safety Quality Service Growth Funding Our Future Coordinated Care Serious Safety Events Health Outcomes Index Patient Satisfaction Percentile Associate Engagement Percentile Physician Engagement Percentile Net Revenue Growth Operating Margin Hospital Cost per Discharge Medical Group Cost per Visit Philanthropy AdvocateCare Index Performance Measurement System Vision SWOT Regulatory Requirements Environmental Scan 1A Annual AHC Strategic Planning 1B Site Strategic Planning Ongoing Review of Metrics for Relevance Annual (or as needed) Results Reviewed Gap Plans PI Projects (as appropriate) 2 Select Key Outcome Performance Measures 3 Determine Comparisons Set Targets (1-5) 4 Goal Cascading (AMS) 7 Systematic Review and Analysis of Data (Schedule) 6 Select Key In-Process Measures 5 Data Collected Revision 4: 08/03/

15 Organizational Quality Documents Document Type Document Name Quality Manual Document Control Quality Policies Control of Records Quality Management System (QMS) Audits Control of Nonconforming Product Corrective Action for Continual Improvement Preventive Action Medical Staff Bylaws (site specific) Scopes of Service (site specific) NIAHOM Documents Nursing Documents Integrated Quality and Patient Safety Plan (site specific) Patient Rights and Responsibilities Utilization Management Plan Physical Environment Management System Plan Infection Prevention Plan (site specific) Lippincott Manual Other Service Agreements Revision Log Revision Approval By Date Notes 1 ISO Steering Committee 03/19/2013 Original release 2 ISO Steering Committee 01/22/2014 Updates 3 ISO Steering Committee 01/09/2015 Updates 3.1 ISO Steering Committee 04/20/2015 Update and input into ADS 4 ISO Steering Committee 07/17/2015 Updates Revision 4: 08/03/

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