Larry Horvath, Director, Health Facilities Division

1. Michigan Ambulatory Surgery AssociationThursday, March 14, 2013FSOF State Licensing Surveys – Overview, Process and Goals2013 Update Larry Horvath, Director, Health Facilities Division Jay Calewarts, Manager, State Licensing SectionMI Department of Licensing & Regulatory Affairs

2. LARA's MissionLARA supports business growth and job creation while safeguarding Michigan's citizens through a simple, fair, efficient and transparent regulatory structure. • LARA's VisionLARA will reinvent government while consistently serving our customers fairly, honestly and respectfully through an engaged and creative employee team. www.michigan.gov

3. Bureau of Health Care Services OCTOBER 18, 2012 – Former Director Hilfinger announced the creation of the new Bureau of Health Care Services. The new bureau brought together the bureaus of Health Professions and Health Systems under one umbrella. This move simplifies the health care regulatory structure, breaking down artificial government silos that are inefficient and impeding improvements in customer service. By combining these bureaus, the department is able to leverage natural synergies in the licensing of providers and facilities, and develop common, effective customer service protocols serving multiple facets of the health care delivery system.

4. Health Facilities Division • The Health Facilities Division (Formerly the Division of Licensing and Certification) is within the Bureau of Health Care Services (formerly Bureau of Health Systems), Michigan Department of Licensing and Regulatory Affairs. • The Division is responsible for state licensing and federal certification of select health facilities, agencies, providers and suppliersas well as state health facilities engineering plan review and inspections and radiation safety certifications.

5. Health Facilities & Agencies State Licensed Health Facilities and Agencies: • Ambulance Operations • Clinical Laboratories • County Medical Care Facilities • Freestanding Surgical Outpatient Facilities (FSOF) • Health Maintenance Organizations (HMO) • Home for the Aged • Hospitals (acute and psychiatric) • Nursing Homes • Hospices • Hospice Residences • Substance Abuse Programs Bold-italics indicates health facilities and agencies state licensed through the Health Facilities Division, LARA.

6. Providers & Suppliers Federally Certified Providers and Suppliers: • Ambulatory Surgical Centers (ASC) • Clinical Laboratories • Comprehensive Outpatient Rehab Facilities (CORF) • End-Stage Renal Disease (ESRD) Centers • Home Health Agencies • Hospices and Residences • Hospitals (acute and psychiatric) • Nursing Homes (CMCF, HLTCU, etc.) • Portable X-Ray Providers • Outpatient Physical/Speech Therapy Providers • Rural Health Clinics Bold-italics indicates providers and suppliers federally certified through the Health Facilities Division, LARA.

7. State/Federal Covered Providers Licensed/Certified Providers in Michigan 2012: • 429 Nursing Homes • 174 Hospitals • 59 Psychiatric Hospitals/Units • 26 Psychiatric Partial Hospitalization Programs • 9 Organ Transplant Facilities • 640 Home Health Agencies • 105 Hospice Programs and 22 Hospice Residences • 176 ESRD Centers (Dialysis) • 172 Rural Health Clinics • 121 FSOF/ASC • 17 CORF • 11 Portable X-Ray Providers • 203 OPT/Speech Pathology • 7,616 Clinical Laboratories • 10,038 Radiological Facilities

8. Ambulatory Surgical Centers • The total number of ambulatory surgical centers has increase 63.2% from FY 2001 to FY 2011. CMS has put a greater focus on increasing the frequency of surveys at ASCs. In FY 2010 states and CMS surveyed approximately 33% of all ASCs, and 25% in FY 2011.

9. Regulatory Overview Sample of Events Requiring State/Federal Approval: • Initiation of inpatient/outpatient surgical services • Federal certification request • Change of ownership • Relocation of surgical facility • Replacement of surgical facility Sample of State Agencies Involved: • Certificate of Need • Health Facilities Engineering • Bureau of Fire Services • Health Facilities Division • Health Professions

10. State Licensing Process • Annual licensure process • Annual inspections required (MCL 333.20155) • Pre-licensure survey, Limited license, post-licensure survey • $238 licensing fee

11. State Licensing Process • Excerpts of Code requirements: • Owner/governing body responsibility • Physicians admitted to practice in facility consistent with capability of facility • Organize, administer, staff and equip to provide regular surgical services • Physicians, nurses and professional staff assure safe performance of surgery • Have written transfer agreement with hospital • Assure proper clinical record management • Excerpts of Rule requirements: • Construction • Disaster and emergency procedures • Surgical procedures/medications • Admission and registration • Records • Physician qualifications • Scrub procedures

12. State Licensing Update • Created the State Licensing Section in November of 2012. • I was hired on November 26, 2012 • Two health care surveyors were transferred from the federal certification sections on December 10, 2012 • Hired a 3rd health care surveyor who started on January 7, 2013.

13. State Licensing Update • Currently 3 health care surveyor dedicated to state licensing surveys • Starting with FSOF and Hospice surveys, eventually will include Hospital (acute and psychiatric) state surveys • Pam Lindsey, RN, dedicated FSOF surveyor • Marian Clore, RN, FSOF and Hospice surveyor • Started conducting FSOF annual surveys January 15 • To date we have completed 22 annual surveys and are now averaging about 3 to 4 a week • Public Act 499

14. Marian and Pam

15. What to Expect (Cont.) • Pam and/or Marian will be conducting a survey w/in a year at all FSOF’s/ASC’s • Survey based on state code and administrative rules • Survey lasts about a half day depending on the size of the facility and types of surgeries conducted at facility, etc. • Deficiencies (if any) noted and usually corrected onsite with surveyor if possible.

16. What to Expect (Cont.) • Report emailed out within a couple of days • No POC. Surveyor will stop back after 60 days to verify deficiency has been corrected. • State code and administrative rules for FSOF’s can be found on our website at www.michigan.gov/bhcs Click on health facilities, then click State Rules and Federal Regulations

17. State Licensing Goals • Conduct an annual survey at every FSOF/ASC in the state • Develop a process that is not overly burdensome for the provider while verifying patient safety • Work with provider to ensure compliance with state licensing rules and regulations • Provide prompt feedback • Follow-up on deficiencies • Update Administrative Rules

18. Working Together • Contact us if you have any suggestions to improve the survey process • Looking at revising the administrative rules, comments welcome • Available for questions • Common goal of providing the best care possible to the patient

19. Helpful Web Sites Health Facilities Division http://www.michigan.gov/lara/0,4601,7-154-35299_63294_63302---,00.html State Code and Rules and Federal Legislation www.michigan.gov/lara/0,4601,7-154-35299_28142_27655_27662-48069--,00.html CMS Conditions for Coverage www.cms.gov/Regulations-and-guidance/Legislation/CFCsAndCoPs/index.html?redirect=/CFCsAndCoPs/01_Overview.asp Ambulatory Surgical Center (ASC) – Federal www.cms.gov/Regulations-and-Guidance/Legislation/CFCsAndCoPs/ASC.html

20. Questions & Answers Health Facilities Division Ottawa Building, 1st Floor 611 W Ottawa Street Lansing, MI 48909 Contact Number: (517) 241-4160 Email: BHS-LC@michigan.gov , calewartsj@michigan.gov Thank you for your efforts to provide quality health care to Michigan residents.