Managing Within the Regulatory Jungle

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Fletcher Allen Health Care
Burlington, VT
Is a CMS Survey in Your Future?
Dawn LeBaron, Vice President for Hospital Services
Jack Conry, Director of Security, Safety, and Parking
Lindsay Harbour, Safety Specialist
www.FletcherAllen.org
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Fletcher Allen Health Care
Three Main Campuses:
 Medical Center Campus
 Fanny Allen Campus
 University Health Center (UHC) Campus
 45+ Satellite Campuses
www.FletcherAllen.org
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Medical Center Campus
 Largest Campus – hospital occupancy
 Facility = 1.5 million SF
 Surface Parking & Grounds = 1 million SF
 Two Garages = 585,000 SF
www.FletcherAllen.org
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Fanny Allen Campus
 2nd Largest Campus – hospital occupancy
 Facility = 118,000 SF
 Surface Parking & Grounds = 948,000 SF
www.FletcherAllen.org
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University Health Center Campus
 Physician Offices – business occupancy
 Facility = 250,000 SF
 Surface Parking & Grounds = 273,000 SF
www.FletcherAllen.org
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Serving a population of one million:
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Level 1 Trauma Center
562 licensed beds, 458 staffed
2,183 births
50,419 inpatient and outpatient
admissions
 60,356 emergency department visits
 1,108,682 physician encounters
www.FletcherAllen.org
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 2.4 million lab tests
 1.44 million meals served
 6,700 employees (including per diem & parttime)
 450 UVM Medical Group physicians (770 total
medical staff)
 280 house staff (physicians in specialty training);
15 residency programs
 $8.7 million in charity care
www.FletcherAllen.org
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Today’s Discussion:
 Health care regulatory agencies
 CMS overview
 What lead to a full CMS survey at Fletcher Allen
 The CMS Life Safety tour and findings
 Life Safety hot spots
 EOC hot spots
 Fletcher Allen’s full Joint Commission Survey
www.FletcherAllen.org
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Regulatory Agencies
Fletcher Allen is reviewed by 30+ agencies.
Primary agencies are:
 Joint Commission
 Centers for Medicare /Medicaid Services ( CMS)
 State / Local Licensing Agencies
www.FletcherAllen.org
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Fletcher Allen Health Care
AgencyName
Division of Licensing and Protection
FY11 (3 quarters)
10/1/10 – 6/30/11
27 Regulatory
“Site Visits”
www.FletcherAllen.org
On-Site Visits
10
CMS
3
Food and Drug Administration
3
VOSHA
2
Joint Commission
2
American Association of Blood banks
1
American College of Surgeons Trauma
1
Division of Alcohol and Drug Abuse Program
1
Division of Mental Health
1
Environmental Protection Agency (EPA)
1
Homeland Security
1
Nuclear Regulatory Commission
1
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FY11 On-Site Regulatory Agency Visits
American Association of Bloodbanks,
1
VOSHA, 2
American College of Surgeons
Trauma, 1
Nuclear Regulatory Commission, 1
CMS, 3
Joint Commission, 2
Division of Alcohol and Drug Abuse
Program, 1
Homeland Security, 1
Food and Drug Administration, 3
Environmental Protection Agency
(EPA), 1
Division of Licensing and Protection,
10
Division of Mental Health, 1
www.FletcherAllen.org
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Fletcher Allen Regulatory Site Visits:
 Division of Licensing and Protection/
CMS (13)
 Complaint Allegation Surveys (10)
 Full Survey (1)
 Durable Medical Equipment (2)
www.FletcherAllen.org
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 Other agencies (14)
 Joint Commission (2)
 1 in response to CMS findings
 1 Stroke Certification
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Environmental Protection Agency (1)
Nuclear Regulatory Commission (1)
FDA (3)
Department of Mental Health (1)
American College of Surgeons (1)
VOSHA (2)
American Association of Bloodbanks (1)
Homeland Security (1)
Division of Alcohol and Drug Abuse (1)
www.FletcherAllen.org
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Regulatory Costs:
 Year to Date = $177, 000
 Includes: Escort, coordination of surveys,
survey interview sessions, development of
POC and writing of plans.
 Other costs:
 TJC follow up survey = $5,000
 Total = $182,000
www.FletcherAllen.org
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CMS
www.FletcherAllen.org
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Is a CMS Survey in Your Future?
Who is CMS?
 A branch of the U.S. Department of Health and
Human Services.
 A federal agency that:
 administers the Medicare program and
 monitors the Medicaid programs offered by each
state.
 The United States is set up into sections of CMS
boards
 Vermont reports to the Boston section.
www.FletcherAllen.org
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What Triggers a CMS Survey?
 Complaint Allegation
 Self Report – Obligated to report:
 Allegations of abuse
 “Critical Incidents” in Mental Health (VT)
 Validation Survey
 Within 60 days of TJC survey
 A quality check on TJC
www.FletcherAllen.org
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CMS Survey Results:
“Statement of Deficiencies”
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No Findings
Standard Level Finding
Conditional Level Finding
Immediate Jeopardy
www.FletcherAllen.org
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Standard Level Finding:
 Typically do not require a response
 However if an organization is found to be out of compliance at
the condition level from a previous finding – they require
response/ follow up survey
Condition Level Finding:
 Requires a formal organizational response.
 It triggers:
 A follow-up “focused survey” and
 A full CMS survey
www.FletcherAllen.org
19
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Immediate Jeopardy:
 Defined by CMS as:
“A crisis situation in which the health and safety of individuals are at
risk (see §SOM 3010).”
 It carries a threat of termination procedures if
“conditions” are not resolved within 23 days.
 The hospital can lose Medicare funding.
 Requires a formal response by organization
 It triggers:
 A follow-up “focused survey” and
 A CMS “full survey” and
 A follow-up “Joint Commission” survey
www.FletcherAllen.org
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So, what happened at Fletcher Allen?
www.FletcherAllen.org
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Monday, December 20, 2010
 3 surveyors arrive unannounced
for a 3 day survey
 4 complaint allegations, 1
involving the Cardiac Cath Lab
Tuesday, January 11, 2011
 End of the day tour of Cath Lab.
 Debris and brown stains on the
floor.
 Cleaning process described.
Cath Lab complaint allegation
involved patient complaint about
consent (only physician can treat).

No EOC involvement at this point
Wednesday, January 12, 2011
 7:30 am continuation of the Cath
Lab tour from 1/11/11.
 Room Cleaning – Trash emptied,
but debris and stains still on floor.
 Patient scheduled for 8:00 am
Tuesday, January 11, 2011
 2 surveyors arrive unannounced
for a 2 day survey
 Follow-up from the 12/20/10
survey
 Focus of survey is Cardiac Cath
Lab and EP (Electrophysiology)
Service
www.FletcherAllen.org
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Cath Lab Survey Results-1/13/11
Four “Condition Level” Findings:
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Governance
Medical Staff
Infection Control
Patient Rights & Ethics
 Plan for Correction (POC) due
2/8/11
 Sparked a full unannounced
CMS survey
www.FletcherAllen.org
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Statement of Deficiencies
&
Plan of Correction
 Corrective action the
hospital will being
implementing
 Plan for educating
 Plan for monitoring
CMS Form 2567
www.FletcherAllen.org
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Wednesday, January 19, 2011
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3 surveyors arrive unannounced for a 3 day
survey (complaint allegation)
Survey focused on the Emergency
Department and EMTALA
EMTALA
Emergency Medical Treatment and Labor Act
 Perform medical screening exam
 Treat/ stabilize
www.FletcherAllen.org
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EMTALA Survey Results
Immediate Jeopardy!
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Posting of Signs (489.20.q)
Medical Screening Exam (489.24.c)
Stabilizing Treatment (489.24.c.1-3)
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Plan of Correction
Sparked a CMS focused survey
Sparked another CMS full survey!
Sparked a JC follow-up survey
www.FletcherAllen.org
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Tuesday, March 8, 2011
Thursday, March 10, 2011
Full CMS Survey:
 1 TJC surveyor arrives
unannounced for a 1 day
survey
 A follow-up survey to the
EMTALA finding.
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13 surveyors arrive
unannounced for a 4 day full
CMS full survey (includes 2
Life Safety Surveyors)
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Originally sparked by
December 2010 Cath Lab
complaint allegation.
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Full Survey offers CMS
surveyors the opportunity to
look at all self reports.
www.FletcherAllen.org
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Surveyor 1

Surgical Services
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Medical Records
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Infection Control
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Nursing: SICU
Surveyor 2
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Discharge Planning
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UR
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Emergency Services
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Nursing: OB, NICU, Pedi ICU
Surveyor 3 & 4
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Rehab: Cost reporting
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Rehab Services
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Outpatient Services
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Nursing: McClure 6
Surveyor 5
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Psych Unit (with Surveyor 9)
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Psych Unit Complaints (2)
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Organ & Tissue Procurement
Surveyor 6
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Compliance with local, state, federal laws
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Governing Body
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Emergency Services (with Surveyor 2)
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Medical Staff
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Nursing: Administrative Review
www.FletcherAllen.org
Surveyor 7
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Pharmacy with 1 complaint
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Radiology
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Nuclear
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Nursing: MICU, Baird 6
Surveyor 8
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Laboratory Services
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Physical Environment
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Respiratory Services
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Nursing: Shepardson 6, Baird 4
Surveyor 9
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Psych Unit (with surveyor 5)
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Shepardson 3, Shepardson 6
Surveyor 10 & 11
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Anesthesia Services
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Patient Rights
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QAPI
Surveyor 12 (Life Safety)
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½ of Medical Center Campus
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Fanny Allen Campus
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4 Satellite Campuses
Surveyor 13 (Life Safety)
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½ of Medical Center Campus
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UHC Campus
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2 Satellite Campuses
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Fletcher Allen’s Survey Plan:
 CMS survey team assigned a large conference
room as their home base.
 Each CMS surveyor assigned a Fletcher Allen
point of contact and escort.
 Fletcher Allen home base established in close
proximity to the CMS home base.
www.FletcherAllen.org
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CMS Full Survey:
An opportunity for surveyors to review all
“self reports”
 Plastic wrist restraints
 Pepper spray
 Immediate Jeopardy!
www.FletcherAllen.org
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Full Survey “Hot Spots”
Resuscitation Carts
 Checked per written policy
Medical Records
 Were orders carried out
 Documentation of action taken
Pain Assessment
 Multidisciplinary assessment
 Documenting assessments
 Completion of care plans
 Assessment per policy
Restraints
 Written order
 Documentation according to policy
Quality & Safety
 Explain PI process and projects
Infection Prevention
 Dressing changes
 Sterile technique
 Toys in waiting rooms
 Cleaning of glucometers
Medication Security
 Med carts locked
 Handling of meds
EOC
 Refrigerator logs
 Hallway clutter
 Alarm response
Patient Confidentiality
 Use of WOW’s
www.FletcherAllen.org
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Environment of Care Issues:
Remember: 13 surveyors look at all of the EOC
 Goose neck faucets on Psychiatric
Unit
 Shower controls on Psychiatric Unit
 Loose handrails in hallways
 Emergency Lighting in “procedure
rooms”
 Security of the Operating Room
 Access signs for the Operating room
 Refrigerator temperature logs in
Dietary
 Temperature and humidity logs in CSR
 Cracked vinyl (tables and mattresses)
www.FletcherAllen.org
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Before
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After
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After
Before
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www.FletcherAllen.org
35
Is a CMS Survey in Your Future?
CMS Life Safety Tour:
 Two Life Safety surveyors – Both state fire marshals
 Two Fletcher Allen escorts
 Four Facilities Management/Safety escorts
 Survey locations divided in two
 Main hospital campus and two satellites
 Fanny Allen campus and four satellites
www.FletcherAllen.org
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Life Safety ‘Hot Spots”
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 Smoke Detectors
Fire stopping
Door closers
Fire doors close and latch
Stairwell storage
Door jambs with no doors
Delayed egress signs
Emergency lighting tests
Obstructed pull stations
GFCI outlets – 6’ from water
Extension cords
www.FletcherAllen.org
 spacing
 36” from air supply
 Power cord daisy chains
 Sprinkler heads in storage
closets
 Storage within 18” of sprinkler
 Electrical Panels
 Labeling (including spares)
 Open spaces
 Broken latches
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CMS Home Base
 13 Surveyor talking among
themselves
 Life Safety surveyor to
Ambulatory Site surveyor:
“Did you know that they are doing
surgery at their Plastic Surgery
site without emergency
lighting?”
 Immediate Jeopardy!
www.FletcherAllen.org
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90 Life Safety Findings:
 GFCI outlets (22)
 Smoke detector/air handler (8)
 Power strips interconnected (7)
 Electrical panel labeling (5)
 Smoke detector spacing (4)
www.FletcherAllen.org
39
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90 Life Safety Findings (continued):
 Penetrations/fire stopping (4)
 Sprinkler head needed (4)
 Door self closer needed (4)
 Fire door does not close and latch (3)
www.FletcherAllen.org
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90 Life Safety Findings (continued):
 Electrical panel, open spaces (3)
 Extension cords (3)
 Electrical panel, broken latch (2)
 Stairwell storage (2)
 Kitchen hoods needed for frying (3)
www.FletcherAllen.org
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90 Life Safety Findings (continued):
 Emergency light malfunction (1)
 Emergency light needed in
generator room (1)
 Pull station blocked (1)
 Store room door removed (1)
 Pre-action valve in stairwell (1)
 Dirty smoke detector (1)
 Storage 18” of sprinkler (1)
 Strobe light blocked (1)
 Outlet cover broken (1)
 Cabinet on power cord (1)
www.FletcherAllen.org
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90 Life Safety Findings (continued):
 Suspended light blocking sprinkler (1)
 Breaker lock missing (1)
 Delayed egress sign (1)
 Delayed egress not approved (1)
 Fire proofing spray on metal beam (1)
 Cooking staff knowledge of fire
suppression system (1)
 Wires above ceiling not supported (1)
 Emergency light malfunction (1)
www.FletcherAllen.org
43
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www.FletcherAllen.org
44
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CMS Lessons Learned:
 It doesn’t matter how old the building. It is still held to
current standards.
 Know your “procedure rooms”.
 Alert others in advance about the route of the tour.
 In most cases, arguing gains nothing.
 Surveyors take pictures and share with other surveyors.
www.FletcherAllen.org
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Joint Commission Survey
Joint Commission Full Survey
 Monday, August 15, 2011
 Seven (7) surveyors including one (1) Life Safety
Engineer
 Full five (5) day survey
 Two (2) day Life Safety survey
www.FletcherAllen.org
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Joint Commission Survey
Environment of Care & Emergency Management Session:
Documents provided upon arrival:
 EOC Committee Meeting Minutes
 Management Plans
 Emergency Operation Plan
 Annual Program Evaluations
 Hazard Vulnerability Analysis
 Inventory of Assets and Resources
www.FletcherAllen.org
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Joint Commission Survey
EOC & EM Issues:
 EM.02.02.13 (EP2) – Not documented in the medical
staff bylaws who may grant disaster privileges.
 EC.02.06.01 (EP1) – Clean utility room with storage
stacked too high to the ceiling. Hazardous to staff.
 EC.02.02.01 (EP5) – Unlocked soiled utility room with
hazardous items accessible to children (used AA
batteries and bottles of cleaning solution).
 IC.02.02.01 (EP3) – Expired surgical gloves, biogel
gloves, and tampons.
www.FletcherAllen.org
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Joint Commission Survey
 LD.04.01.01 (EP3) –
Exposed pipes
under sinks in
handicapped
bathrooms (ADA
violation).
www.FletcherAllen.org
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Joint Commission Survey
Life Safety Survey:
Day One:
Documentation Review
Day Two:
Building Tour
www.FletcherAllen.org
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Joint Commission Survey
TJC Life Safety Survey:
Fletcher Allen Issues
 EC.02.03.05 (EP6) – Documentation that electric fire
pumps were run weekly for 10 minutes.
 EC.02.03.05 (EP10) – No documentation for the
quarterly inspection of water supply connections.
 EC.02.03.05 (EP19) – No inventory of fans to ensure
that all air handling units shut down properly.
 EC.02.05.07 (EP4) – 42 days between generator tests
one month of the year.
 EC.02.05.07 (EP6) – 42 days between automatic
transfer switch test one month of the year.
www.FletcherAllen.org
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Joint Commission Survey
TJC Life Safety Survey:
Fletcher Allen Issues (continued)
 EC.02.05.07 (EP7) – No documentation that emergency
generator was operated for 4 continuous hours at least
every 36 months.
 EC.02.05.07 (EP8) – No documentation that emergency
generator was operated at 30% nameplate rating for 4
continuous hours at least every 36 months.
 LS.01.02.01 (EP3) – Written ILSM risk assessments not
completed for each SOC Plan for Improvement.
 LS.02.01.10 (EP5) – Fire door did not close and latch
with vertical gap greater than 1/8”.
www.FletcherAllen.org
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Joint Commission Survey
TJC Life Safety Survey:|
Issues continued:
 LS.02.01.01 (EP6) – Fire door
with kick plate larger than 16”.
 LS.02.01.20 (EP13) – Hallway
clutter (medication carts and
soiled linen hampers).
 LS.02.01.35 (EP4) – Conduit
and HVAC duct resting on
sprinkler pipes.
www.FletcherAllen.org
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Joint Commission Survey
Joint Commission Lessons Learned:
 Documentation – Get it to the surveyors early.
 Binders – Develop binders for documents the
surveys are likely to request.
 Have a plan for replacing organizational
“experts”, if they are “on vacation”.
www.FletcherAllen.org
54
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Questions?
www.FletcherAllen.org
55
Is a CMS Survey in Your Future?
Fletcher Allen Contact Information:
Dawn LeBaron, Vice President for Hospital Services
 802-847-2805
 Dawn.lebaron@vtmednet.org
Lindsay Harbour, Safety Specialist
 802-847-2284
 Lindsay.harbour@vtmednet.org
Jack Conry, Director of Security, Safety, and Parking
 802-847-2812
 Jack.conry@vtmednet.org
www.FletcherAllen.org
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