larry horvath, director, health facilities division

C U S T O M E R D R I V E N. B U S I N E S S M I N D E D.

Michigan Ambulatory Surgery Association

Thursday, March 14, 2013

FSOF State Licensing Surveys – Overview, Process and Goals

2013 Update

Larry Horvath, Director, Health Facilities DivisionJay Calewarts, Manager, State Licensing SectionMI Department of Licensing & Regulatory Affairs


• 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


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.


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 suppliers as well as state health facilities engineering plan review and inspections and radiation safety certifications.


Health Facilities & Agencies

State Licensed Health Facilities and Agencies:

Ambulance OperationsClinical LaboratoriesCounty Medical Care FacilitiesFreestanding Surgical Outpatient Facilities (FSOF)Health Maintenance Organizations (HMO)Home for the AgedHospitals (acute and psychiatric)Nursing HomesHospicesHospice ResidencesSubstance Abuse Programs

Bold-italics indicates health facilities and agencies state licensed through the Health Facilities Division, LARA.


Providers & SuppliersFederally Certified Providers and Suppliers:

Ambulatory Surgical Centers (ASC)Clinical LaboratoriesComprehensive Outpatient Rehab Facilities (CORF)End-Stage Renal Disease (ESRD) CentersHome Health AgenciesHospices and ResidencesHospitals (acute and psychiatric)Nursing Homes (CMCF, HLTCU, etc.)Portable X-Ray ProvidersOutpatient Physical/Speech Therapy ProvidersRural Health Clinics

Bold-italics indicates providers and suppliers federally certified through the Health Facilities Division, LARA.


State/Federal Covered ProvidersLicensed/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


Ambulatory Surgical CentersThe 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.


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


State Licensing Process

• Annual licensure process

• Annual inspections required (MCL 333.20155)

• Pre-licensure survey, Limited license, post-licensure survey

• $238 licensing fee


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


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.


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


Marian and Pam


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.


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/bhcsClick on health facilities, then click State Rules and Federal Regulations


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


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


Helpful Web Sites

Health Facilities Divisionhttp://www.michigan.gov/lara/0,4601,7-154-35299_63294_63302---,00.html

State Code and Rules and Federal Legislationwww.michigan.gov/lara/0,4601,7-154-35299_28142_27655_27662-

48069--,00.html

CMS Conditions for Coveragewww.cms.gov/Regulations-and-guidance/Legislation/CFCsAndCoPs/

index.html?redirect=/CFCsAndCoPs/01_Overview.asp

Ambulatory Surgical Center (ASC) – Federalwww.cms.gov/Regulations-and-Guidance/Legislation/CFCsAndCoPs/ASC.html


Questions & Answers

Health Facilities DivisionOttawa Building, 1st Floor

611 W Ottawa StreetLansing, MI 48909

Contact Number: (517) 241-4160 Email: [email protected] , [email protected]

Thank you for your efforts to provide quality health care to Michigan residents.

larry horvath, director, health facilities division

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