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

Exhibit OO17.1 Advocate BroMenn Medical Center

Quality Manual

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.

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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.

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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.

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The table below offers a profile summary for the hospitals within Advocate Health Care.

Advocate BroMenn Medical Center

Normal, IL

221

4

Level – II

Level – II

• Chest Pain Center Accreditation

• Primary Stroke Center Certification

Advocate Christ Medical Center • ANCC as Magnet nursing hospital • Advanced Heart Failure Certification • Comprehensive Level – IIIc Stroke Center

Certification (Children’s • Ventricular Assist Oak Lawn, IL 690 5 Level – I Hospital) Device Certification

Advocate Condell Medical Center • Chest Pain Center Accreditation • Primary Stroke Libertyville, IL 273 9 Level – I Level – II+ Center Certification

Advocate Good Samaritan Hospital • ANCC as Magnet nursing hospital • Chest Pain Center Accreditation • 2010 Malcolm Baldrige National Quality Award Downers Grove, • Primary Stroke IL 333 4 Level – I Level – III Center Certification

Advocate Good Shepherd Hospital • ANCC as Magnet Nursing hospital • Primary Stroke Center Certification • Chest Pain Center Barrington, IL 169 8 Level – II Level - IIe Accreditation

Advocate Illinois Masonic Medical • ANCC as Magnet Center nursing hospital

• Primary Stroke Chicago, IL 408 8 Level – I Level – III Center Certification

Advocate Lutheran General • ANCC as Magnet Hospital Level – III nursing hospital

(Children’s • Primary Stroke Park Ridge, IL 521 4 Level – I Hospital) Center Certification

Advocate South Suburban Hospital • Primary Stroke Hazel Crest, IL 284 1 Level - IIe Center Accreditation

Advocate Sherman Hospital • ANCC as Magnet nursing hospital • Primary Stroke Center Certification • Chest Pain Center Elgin, IL. 255 10 Level-11 Level - IIe Accreditation

Advocate Trinity Hospital • Primary Stroke Chicago, IL 193 2 Level - IIe Center Certification

Advocate Eureka Hospital Eureka, IL 25 -

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:

Children’s Hospital: Advocate Children’s Hospital

Oak Lawn

Oak Lawn, IL

106

-

Level – IIIc

Park Ridge

Park Ridge, IL

117

-

Level – I

Level – III

Critical Access Hospital:

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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

Key: CARF = Commission on Accreditation of Rehabilitation Facilities

ANCC = American Nursing Credentialing Center = YES

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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

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• 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

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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

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• 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

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• 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.

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Safety, Quality, Service: The Advocate Experience Advocate Process Map

Leadership Oriented Processes

ACCESS DIAGNOSE/ TREAT

TRANSITION

Patient Oriented Processes

Patient Oriented Support Processes

Support Processes

2/9/2015

Infection

Prevention

Facilities

EVS

Medical Staff

Services

HIM

Biomedical Engineering

Revenue

Cycle

Human

Resources

Contracted

Services

Security

Education

Research

Guest Services/ Patient

Relations

Quality/Risk/ Safety

Innovation

Supply Chain

Information

Systems

Community

and Wellness

Care

Management

Rehab/ Therapy Services

Wound Care

CV Services

Respiratory

Pharmacy

Laboratory

Nutrition

Imaging

Ambulatory

Clinic

Surgical & Procedural Services

Mission &

Spiritual Care

Patient Access

Post

Partum

Labor and Delivery

Nursery

Key Work System

Inpatient Care

MVP

Legal & Ethics

Oversight

Finance

Marketing

Charitible

Foundation

Business Development

Strategic Planning

Administration/

Medical Staff

Governing

Council

Home

Key Work System

Emergency Care

Key Work System

Outpatient Care

Home Health/ Hospice

Transition

of Care

Skilled Nursing/

Rehab Behavioral

Health

Long Term Acute Care Hospital

Med/Surg

Pediatrics

Tele

Critical Care

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Quality Management Oversight Committee Structure

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

Medical Executive Committee (MEC)

Advocate Health Care

Board of Directors

Reporting Exchange

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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)

Performance Measurement System

10

9

3 Determine Comparisons

Set Targets (1-5)

7

1B 1A Annual AHC Strategic Planning

Site Strategic Planning

Ongoing Review of Metrics for Relevance

Annual (or as needed)

Results Reviewed

4 Goal Cascading (AMS)

Systematic Review and

Analysis of Data (Schedule)

6 Select Key In-Process Measures

5

Data Collected

2 Select Key Outcome

Performance Measures

8 Gap Plans PI Projects

(as appropriate)

Environmental Scan

Regulatory Requirements SWOT Vision

Coordinated Care

AdvocateCare Index

Funding Our Future

Operating Margin

Hospital Cost per Discharge Medical Group Cost per Visit

Philanthropy

Growth

Net Revenue Growth

Quality Service

Health Outcomes Index

Patient Satisfaction Percentile

Associate

Engagement Percentile

Physician Engagement Percentile

Safety

Serious Safety Events

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Organizational Quality Documents

Document Type Document Name

Quality Policies

Quality Manual

Document Control

Control of Records

Quality Management System (QMS) Audits

Control of Nonconforming Product

Corrective Action for Continual Improvement

Preventive Action

NIAHOM

Documents

Medical Staff Bylaws (site specific)

Scopes of Service (site specific)

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)

Nursing Documents

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

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