PRINTED: 02/03/2020 DEPARTMENT OF HEALTH AND HUMAN ... · tag id provider's plan of correction...
Transcript of PRINTED: 02/03/2020 DEPARTMENT OF HEALTH AND HUMAN ... · tag id provider's plan of correction...
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(X1) PROVIDER/SUPPLIER/CLIA
DEPARTMENT OF HEALTH AND HUMAN SERVICES
CENTERS FOR MEDICARE & MEDICAID SERVICES
02/03/2020PRINTED:
FORM APPROVED
OMB NO. 0938-039
STATEMENT OF DEFICIENCIES
AND PLAN OF CORRECTION IDENTIFICATION NUMBER
(X2) MULTIPLE CONSTRUCTION
A. BUILDING
B. WING
(X3) DATE SURVEY
COMPLETED
NAME OF PROVIDER OR SUPPLIERSTREET ADDRESS, CITY, STATE, ZIP COD
(X4) ID
PREFIX
TAG
SUMMARY STATEMENT OF DEFICIENCIE
(EACH DEFICIENCY MUST BE PRECEDED BY FULL
REGULATORY OR LSC IDENTIFYING INFORMATION
PREFIX
TAG
IDPROVIDER'S PLAN OF CORRECTION
(EACH CORRECTIVE ACTION SHOULD BE
DEFICIENCY)
(X5)
COMPLETION
DATECROSS-REFERENCED TO THE APPROPRIATE
SEYMOUR, IN 47274
152567 01/14/2020
FRESENIUS MEDICAL CARE SEYMOUR
200 E THIRD ST
00
E 0000
Bldg. 00
An Emergency Preparedness Survey was
conducted by the Indiana State Department of
Health in accordance with 42 CFR 494.62.
Survey Dates: January 9th, 10th, 13th, and 14th of
2020.
Facility Number: 002497
Provider Number: 152567
Census: 47 in-center hemodialysis
0 home peritoneal dialysis
0 home hemodialysis
At this Emergency Preparedness survey,
Fresenius Medical Care Seymour was found in
compliance with Emergency Preparedness
Requirements for Medicare Participating Providers
and Suppliers, 42 CFR 494.62.
E 0000 The Letter of Credible Allegation and administrator signature on
SOD were uploaded as supporting
documentation.
V 0000
Bldg. 00
This visit was for a federal ESRD (Core)
recertification survey. This visit included an
Investigation of Complaint IN00255124
Complaint IN00255124 - Substantiated. Federal
deficiencies related to the allegations were cited.
Survey Dates: January 9th, 10th, 13th, and 14th of
2020
Facility Number: 002497
Provider Number: 152567
V 0000 The Letter of Credible Allegation and administrator signature on
SOD were uploaded as supporting
documentation.
FORM CMS-2567(02-99) Previous Versions Obsolete
Any defiencystatement ending with an asterisk (*) denotes a deficency which the institution may be excused from correcting providing it is determin
other safegaurds provide sufficient protection to the patients. (see instructions.) Except for nursing homes, the findings stated above are disclosable
following the date of survey whether or not a plan of correction is provided. For nursing homes, the above findings and plans of correction are disclo
days following the date these documents are made available to the facility. If deficiencies are cited, an approved plan of correction is requisite to
continued program participation.
LABORATORY DIRECTOR'S OR PROVIDER/SUPPLIER REPRESENTATIVE'S SIGNATURE
_____________________________________________________________________________________________________Event ID: MEIC11 Facility ID: 002497
TITLE
If continuation sheet Page 1 of 38
(X6) DATE
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(X1) PROVIDER/SUPPLIER/CLIA
DEPARTMENT OF HEALTH AND HUMAN SERVICES
CENTERS FOR MEDICARE & MEDICAID SERVICES
02/03/2020PRINTED:
FORM APPROVED
OMB NO. 0938-039
STATEMENT OF DEFICIENCIES
AND PLAN OF CORRECTION IDENTIFICATION NUMBER
(X2) MULTIPLE CONSTRUCTION
A. BUILDING
B. WING
(X3) DATE SURVEY
COMPLETED
NAME OF PROVIDER OR SUPPLIERSTREET ADDRESS, CITY, STATE, ZIP COD
(X4) ID
PREFIX
TAG
SUMMARY STATEMENT OF DEFICIENCIE
(EACH DEFICIENCY MUST BE PRECEDED BY FULL
REGULATORY OR LSC IDENTIFYING INFORMATION
PREFIX
TAG
IDPROVIDER'S PLAN OF CORRECTION
(EACH CORRECTIVE ACTION SHOULD BE
DEFICIENCY)
(X5)
COMPLETION
DATECROSS-REFERENCED TO THE APPROPRIATE
SEYMOUR, IN 47274
152567 01/14/2020
FRESENIUS MEDICAL CARE SEYMOUR
200 E THIRD ST
00
Census: 47 in-center hemodialysis
0 home peritoneal dialysis
0 home hemodialysis
Record review: 8
Fresenius Medical Care Seymour was found to
not be in compliance with Conditions for
Coverage Subpart B CFR 494.30: Infection
Control; and Condition for Coverage 42 CFR
494.60 Physical Environment.
494.30
CFC-INFECTION CONTROL
V 0110
Bldg. 00
Based on observation, record review, and
interview, the facility failed to ensure infection
control precautions were maintained (See Tag
V112); failed to ensure sinks were plumbed with
hot water (See Tag V114); failed to store unused
equipment was off of the dialysis treatment area
countertops (See Tag V116); failed to ensure
cross contamination did not occur between
patients and clean and dirty sinks (See Tag V117);
failed to perform appropriate hand hygiene after
assessing a patient and prior to cleaning
equipment and failed to follow applicable infection
control procedures when cleaning and
disinfecting contaminated surfaces and equipment
(See Tag V122)
The cumulative effect of this systemic problem
resulted in the facility being out of compliance
with the Condition for Coverage 42 CFR 494.30
Infection Control.
V 0110 V110 CFC- INFECTION CONTROL CFR(s): 494.30
The Governing Body of this facility
acknowledges its responsibility to
ensure all staff follow approved
policies and procedures for
Infection Control and continue to
develop, analyze and revise action
plans regarding Infection Control
concerns to ensure ongoing
compliance.
The Governing Body met on
January 29, 2020 and reviewed the
Statement of Deficiencies and
developed the following Plan of
Correction ensuring that
deficiencies are addressed, both
immediately and with long term
resolution.
The Governing Body began
meeting weekly beginning on
February 3, 2020, to monitor the
progress of the Plan of Correction
ensuring that deficiencies are
02/13/2020 12:00:00AM
FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: MEIC11 Facility ID: 002497 If continuation sheet Page 2 of 38
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(X1) PROVIDER/SUPPLIER/CLIA
DEPARTMENT OF HEALTH AND HUMAN SERVICES
CENTERS FOR MEDICARE & MEDICAID SERVICES
02/03/2020PRINTED:
FORM APPROVED
OMB NO. 0938-039
STATEMENT OF DEFICIENCIES
AND PLAN OF CORRECTION IDENTIFICATION NUMBER
(X2) MULTIPLE CONSTRUCTION
A. BUILDING
B. WING
(X3) DATE SURVEY
COMPLETED
NAME OF PROVIDER OR SUPPLIERSTREET ADDRESS, CITY, STATE, ZIP COD
(X4) ID
PREFIX
TAG
SUMMARY STATEMENT OF DEFICIENCIE
(EACH DEFICIENCY MUST BE PRECEDED BY FULL
REGULATORY OR LSC IDENTIFYING INFORMATION
PREFIX
TAG
IDPROVIDER'S PLAN OF CORRECTION
(EACH CORRECTIVE ACTION SHOULD BE
DEFICIENCY)
(X5)
COMPLETION
DATECROSS-REFERENCED TO THE APPROPRIATE
SEYMOUR, IN 47274
152567 01/14/2020
FRESENIUS MEDICAL CARE SEYMOUR
200 E THIRD ST
00
addressed, both immediately and
with long term resolution. The
Governing Body will determine
when the frequency of these
meetings may be reduced to the
regular quarterly schedule.
Effective immediately:
·The Clinical Manager will
analyze and trend all data and
monitor/audit results as related to
this Plan of Correction prior to
presenting the monthly data to the
QAI Committee.
·A specific plan of action
encompassing the citations as
cited in the Statement of
Deficiency has been added to the
facility’s monthly QAI (Quality
Assessment and Performance
Improvement) agenda.
·The QAI Committee is
responsible to review and evaluate
the Plan of Correction to ensure it
is effective and is providing
resolution of the issues.
·The Director of Operations (DO)
will present a report on the Plan of
Correction data and all actions
taken toward the resolution of the
deficiencies at each Governing
Body meeting through to the
sustained resolution of all
identified issues.
·The Governing Body, at its
meeting of January 29, 2020,
designated the Director of
Operations (DO) to serve as Plan
of Correction Monitor and provide
additional oversight. They will
participate in QAPI and Governing
FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: MEIC11 Facility ID: 002497 If continuation sheet Page 3 of 38
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(X1) PROVIDER/SUPPLIER/CLIA
DEPARTMENT OF HEALTH AND HUMAN SERVICES
CENTERS FOR MEDICARE & MEDICAID SERVICES
02/03/2020PRINTED:
FORM APPROVED
OMB NO. 0938-039
STATEMENT OF DEFICIENCIES
AND PLAN OF CORRECTION IDENTIFICATION NUMBER
(X2) MULTIPLE CONSTRUCTION
A. BUILDING
B. WING
(X3) DATE SURVEY
COMPLETED
NAME OF PROVIDER OR SUPPLIERSTREET ADDRESS, CITY, STATE, ZIP COD
(X4) ID
PREFIX
TAG
SUMMARY STATEMENT OF DEFICIENCIE
(EACH DEFICIENCY MUST BE PRECEDED BY FULL
REGULATORY OR LSC IDENTIFYING INFORMATION
PREFIX
TAG
IDPROVIDER'S PLAN OF CORRECTION
(EACH CORRECTIVE ACTION SHOULD BE
DEFICIENCY)
(X5)
COMPLETION
DATECROSS-REFERENCED TO THE APPROPRIATE
SEYMOUR, IN 47274
152567 01/14/2020
FRESENIUS MEDICAL CARE SEYMOUR
200 E THIRD ST
00
Body meetings. This additional
oversight is to ensure the ongoing
correction of deficiencies cited in
the Statement of Deficiency
through to resolution as well as
ensure the Governance of the
Facility is presented current and
complete data to enhance their
governance oversight role.
Minutes of the Governing Body
and QAI meetings, as well as
monitoring forms and educational
documentation will provide
evidence of these actions, the
Governing Body’s direction and
oversight and the QAI Committees
ongoing monitoring of facility
activities. These are available for
review at the facility.
The responses provided for V112,
V114, V116, V117 and V122
describe, in detail, the processes
and monitoring steps taken to
ensure that all deficiencies as
cited within this Condition are
corrected to ensure ongoing
compliance.
494.30(a)
IC-CDC MMWR 2001
The facility must demonstrate that it follows
standard infection control precautions by
implementing-
(1)(i) The recommendations (with the
exception of screening for hepatitis C), found
in "Recommendations for Preventing
Transmission of Infections Among Chronic
Hemodialysis Patients," developed by the
Centers for Disease Control and Prevention,
Morbidity and Mortality Weekly Report,
V 0112
Bldg. 00
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(X1) PROVIDER/SUPPLIER/CLIA
DEPARTMENT OF HEALTH AND HUMAN SERVICES
CENTERS FOR MEDICARE & MEDICAID SERVICES
02/03/2020PRINTED:
FORM APPROVED
OMB NO. 0938-039
STATEMENT OF DEFICIENCIES
AND PLAN OF CORRECTION IDENTIFICATION NUMBER
(X2) MULTIPLE CONSTRUCTION
A. BUILDING
B. WING
(X3) DATE SURVEY
COMPLETED
NAME OF PROVIDER OR SUPPLIERSTREET ADDRESS, CITY, STATE, ZIP COD
(X4) ID
PREFIX
TAG
SUMMARY STATEMENT OF DEFICIENCIE
(EACH DEFICIENCY MUST BE PRECEDED BY FULL
REGULATORY OR LSC IDENTIFYING INFORMATION
PREFIX
TAG
IDPROVIDER'S PLAN OF CORRECTION
(EACH CORRECTIVE ACTION SHOULD BE
DEFICIENCY)
(X5)
COMPLETION
DATECROSS-REFERENCED TO THE APPROPRIATE
SEYMOUR, IN 47274
152567 01/14/2020
FRESENIUS MEDICAL CARE SEYMOUR
200 E THIRD ST
00
volume 50, number RR05, April 27, 2001,
pages 18 to 28. The Director of the Federal
Register approves this incorporation by
reference in accordance with 5 U.S.C. 552(a)
and 1 CFR Part 51. This publication is
available for inspection at the CMS
Information Resource Center, 7500 Security
Boulevard, Central Building, Baltimore, MD or
at the National Archives and Records
Administration (NARA). Copies may be
obtained at the CMS Information Resource
Center. For information on the availability of
this material at NARA, call 202-741-6030, or
go to:
http://www.archives.gov/federal_register/code
_of_regulations/ibr_locations.html.
The recommendation found under section
header "HBV-Infected Patients", found on
pages 27 and 28 of RR05
("Recommendations for Preventing
Transmission of Infections Among Chronic
Hemodialysis Patients"), concerning isolation
rooms, must be complied with by February 9,
2009.
Based on observation and record review, the
facility failed to ensure infection control
precautions were maintained for 2 of 14 patient
observations. (Patient 16 & 17)
Findings include:
1. A 1/4/12 policy titled "Dialysis Precautions"
was provided by the clinical manager on 1/10/20 at
10:25 a.m. The policy indicated, but was not
limited to, "Dialysis Precautions will be followed
by all employees with potential exposure to
bloodborne pathogens and other potentially
infectious material (OPIM) in the dialysis setting
V 0112 V112 IC-CDC MMWR 2001 CFR(s): 494.30(a)
The Clinic Manager will educate
and elicit input from relevant staff
by February 1, 2020, on the
expectations and responsibilities
to comply with the following
policy:
·FMS-CS-IC-II-155-070A
Dialysis Precautions Policy
Emphasis was placed on:
·Clean areas will be clearly
separated from dirty areas where
used supplies, equipment or blood
samples are handled or stored.
02/12/2020 12:00:00AM
FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: MEIC11 Facility ID: 002497 If continuation sheet Page 5 of 38
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(X1) PROVIDER/SUPPLIER/CLIA
DEPARTMENT OF HEALTH AND HUMAN SERVICES
CENTERS FOR MEDICARE & MEDICAID SERVICES
02/03/2020PRINTED:
FORM APPROVED
OMB NO. 0938-039
STATEMENT OF DEFICIENCIES
AND PLAN OF CORRECTION IDENTIFICATION NUMBER
(X2) MULTIPLE CONSTRUCTION
A. BUILDING
B. WING
(X3) DATE SURVEY
COMPLETED
NAME OF PROVIDER OR SUPPLIERSTREET ADDRESS, CITY, STATE, ZIP COD
(X4) ID
PREFIX
TAG
SUMMARY STATEMENT OF DEFICIENCIE
(EACH DEFICIENCY MUST BE PRECEDED BY FULL
REGULATORY OR LSC IDENTIFYING INFORMATION
PREFIX
TAG
IDPROVIDER'S PLAN OF CORRECTION
(EACH CORRECTIVE ACTION SHOULD BE
DEFICIENCY)
(X5)
COMPLETION
DATECROSS-REFERENCED TO THE APPROPRIATE
SEYMOUR, IN 47274
152567 01/14/2020
FRESENIUS MEDICAL CARE SEYMOUR
200 E THIRD ST
00
... Approach all patients as if they are infectious ...
Approach all supplies and equipment used for a
patient's treatment as if they are contaminated ...
Clean area: An area designated for clean and
unused equipment, supplies and medications ...
Clean areas should be clearly separated from dirty
areas where used supplies, equipment or blood
samples are handled or stored."
2. During an observation on 1/10/20 at 9:25 a.m.,
patient 16's right arm was resting on the clean sink
during dialysis treatment. At 9:32 a.m. patient 16's
right arm and hand was in the clean sink. At 9:35
a.m. patient 16 placed his right arm and hand
across and into the designated clean sink at
station 11. The space between the sink and the
armrest was approximately less than an inch. This
sink was also shared with patient #17.
3. During an observation on 1/10/20 at 9:30 a.m.,
patient 17's left arm was resting on his personal
pillow partially across the clean sink at station 10.
The space between the sink and the armrest was
approximately less than an inch. This sink was
also shared with patient #16.
4. During an interview on 1/10/20 at 12:30 p.m.,
the director of operations and the clinical manager
were unable to provide any additional information.
·Sufficient space will be
dedicated between patient station
and clean / dirty sinks.
·One “dirty sink” will be removed
to improve patient comfort while on
treatment.
·5 patient TV’s will be moved to
increase space in hemodialysis
station and dedicated clean / dirty
sinks.
Effective on February 3, 2020, the
Clinic Manager or designee will
conduct infection control audits
twice daily for 2 weeks, then once
daily for 2 weeks, then five times
weekly for one month, then weekly
for one month utilizing the
Infection Control & Patient
Treatment Monitoring Tool. The
focus will be on clearly separating
clean areas from dirty areas.
Once 100% compliance is
sustained, monitoring will be
completed per the Quality
Assessment and Performance
Improvement (QAI) calendar with
oversight from the Governing
Body.
The Medical Director will review
the results of audits each month
at the QAI Committee meeting
monthly. The Clinical Manager is
responsible to review, analyze and
trend all data and Monitor/Audit
results as related to this Plan of
Correction prior to presenting to
the QAI Committee monthly. The
Director of Operations is
responsible to present the status
of the Plan of Correction and all
FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: MEIC11 Facility ID: 002497 If continuation sheet Page 6 of 38
-
(X1) PROVIDER/SUPPLIER/CLIA
DEPARTMENT OF HEALTH AND HUMAN SERVICES
CENTERS FOR MEDICARE & MEDICAID SERVICES
02/03/2020PRINTED:
FORM APPROVED
OMB NO. 0938-039
STATEMENT OF DEFICIENCIES
AND PLAN OF CORRECTION IDENTIFICATION NUMBER
(X2) MULTIPLE CONSTRUCTION
A. BUILDING
B. WING
(X3) DATE SURVEY
COMPLETED
NAME OF PROVIDER OR SUPPLIERSTREET ADDRESS, CITY, STATE, ZIP COD
(X4) ID
PREFIX
TAG
SUMMARY STATEMENT OF DEFICIENCIE
(EACH DEFICIENCY MUST BE PRECEDED BY FULL
REGULATORY OR LSC IDENTIFYING INFORMATION
PREFIX
TAG
IDPROVIDER'S PLAN OF CORRECTION
(EACH CORRECTIVE ACTION SHOULD BE
DEFICIENCY)
(X5)
COMPLETION
DATECROSS-REFERENCED TO THE APPROPRIATE
SEYMOUR, IN 47274
152567 01/14/2020
FRESENIUS MEDICAL CARE SEYMOUR
200 E THIRD ST
00
other actions taken toward the
resolution of the deficiencies at
each Governing Body meeting
through to the sustained resolution
of all identified issues. The QAI
Committee is responsible to
provide oversight, review findings,
and take actions as appropriate.
The Governing Body is responsible
to provide oversight to ensure the
Plan of Correction, as written to
address the issues identified by
the Statement of Deficiency, is
effective and is providing resolution
of the issues.
Documentation of education,
monitoring, QAI, and Governing
Body is available for review.
The Clinic Manager is responsible
for overall compliance.
494.30(a)(1)(i)
IC-SINKS AVAILABLE
A sufficient number of sinks with warm water
and soap should be available to facilitate
hand washing.
V 0114
Bldg. 00
Based on observation and interview, the facility
failed to ensure sinks were plumbed with hot
water for 3 of 6 observations. (3 Sinks)
Findings include:
1. A 11/4/19 policy titled "Hand Hygiene" was
provided by the clinical manager on 1/10/20 at
10:25 a.m. The policy indicated, but was not
limited to, "A sufficient number of sinks with soap
and plumbed with both hot and cold water shall
be available to facilitate hand hygiene."
V 0114 Immediate actions taken by the Director of Operations, Clinic
Manager, and Area Technical
Operations Manager on January
10, 2020 during the survey are as
follows:
·Plumbing contractors notified
and repairs to water temperature
for hand sinks completed on
1/10/2020
The Clinic Manager will educate
and elicit input from relevant staff
by February 1, 2020, on the
02/13/2020 12:00:00AM
FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: MEIC11 Facility ID: 002497 If continuation sheet Page 7 of 38
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(X1) PROVIDER/SUPPLIER/CLIA
DEPARTMENT OF HEALTH AND HUMAN SERVICES
CENTERS FOR MEDICARE & MEDICAID SERVICES
02/03/2020PRINTED:
FORM APPROVED
OMB NO. 0938-039
STATEMENT OF DEFICIENCIES
AND PLAN OF CORRECTION IDENTIFICATION NUMBER
(X2) MULTIPLE CONSTRUCTION
A. BUILDING
B. WING
(X3) DATE SURVEY
COMPLETED
NAME OF PROVIDER OR SUPPLIERSTREET ADDRESS, CITY, STATE, ZIP COD
(X4) ID
PREFIX
TAG
SUMMARY STATEMENT OF DEFICIENCIE
(EACH DEFICIENCY MUST BE PRECEDED BY FULL
REGULATORY OR LSC IDENTIFYING INFORMATION
PREFIX
TAG
IDPROVIDER'S PLAN OF CORRECTION
(EACH CORRECTIVE ACTION SHOULD BE
DEFICIENCY)
(X5)
COMPLETION
DATECROSS-REFERENCED TO THE APPROPRIATE
SEYMOUR, IN 47274
152567 01/14/2020
FRESENIUS MEDICAL CARE SEYMOUR
200 E THIRD ST
00
2. A janitorial contract titled "2019 RFP Contract
Exhibit A" was provided by the clinical manger on
1/10/20 at 10:42 a.m. The policy indicated, but was
not limited to, " c) Report leaking faucets, clogged
drains, or any other maintenance type problems to
appropriate party ..."
3. During an observation on 1/9/20 at 11:40 a.m.,
the employee restroom sink failed to be plumbed
with hot water.
4. During an observation on 1/10/20 at 8:00 a.m.,
the employee restroom sink failed to be plumbed
with hot water.
5. During an observation on 1/10/20 at 8:30 a.m., 2
sinks, made available for patients to wash their
access sites prior to treatment and their hands
after treatment, failed to be plumbed with hot
water.
6. During an interview on 1/10/20 at 8:45 a.m., the
clinical manager stated they were aware of the
sinks not having hot water and was due to the
distance from the sinks to the hot water heater.
At 10:42 a.m. the clinical manager stated employee
O, regional Bio-Med technician, was able to flip a
switch and hot water began to recirculate to the
sinks.
expectations and responsibilities
to comply with the following policy
and procedure:
·FMS- CS- IC- II 155-090A
Hand Hygiene Policy
·FMS-CS-1C-11-155-090C
Hand Hygiene Procedure
Emphasis was placed on:
·Ensuring sinks will be plumbed
with hot and cold water to facilitate
handwashing.
·New hot water heater installed
on 1/19/20 with direct feed to all
handwashing sinks.
·Improved process to
communicate physical plant
issues.
·Educating staff and patients on
infection control practices for
hemodialysis units.
Effective on February 3, 2020, the
Clinic Manager or designee will
conduct infection control audits
twice daily for 2 weeks, then once
daily for 2 weeks, then five times
weekly for one month, then weekly
for one month utilizing the
Infection Control & Patient
Treatment Monitoring Tool. The
focus will be on all hand washing
sinks to have hot and cold water.
Once 100% compliance is
sustained, monitoring will be
completed per the Quality
Assessment and Performance
Improvement (QAI) calendar with
oversight from the Governing
Body.
The Medical Director will review
the results of audits each month
FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: MEIC11 Facility ID: 002497 If continuation sheet Page 8 of 38
-
(X1) PROVIDER/SUPPLIER/CLIA
DEPARTMENT OF HEALTH AND HUMAN SERVICES
CENTERS FOR MEDICARE & MEDICAID SERVICES
02/03/2020PRINTED:
FORM APPROVED
OMB NO. 0938-039
STATEMENT OF DEFICIENCIES
AND PLAN OF CORRECTION IDENTIFICATION NUMBER
(X2) MULTIPLE CONSTRUCTION
A. BUILDING
B. WING
(X3) DATE SURVEY
COMPLETED
NAME OF PROVIDER OR SUPPLIERSTREET ADDRESS, CITY, STATE, ZIP COD
(X4) ID
PREFIX
TAG
SUMMARY STATEMENT OF DEFICIENCIE
(EACH DEFICIENCY MUST BE PRECEDED BY FULL
REGULATORY OR LSC IDENTIFYING INFORMATION
PREFIX
TAG
IDPROVIDER'S PLAN OF CORRECTION
(EACH CORRECTIVE ACTION SHOULD BE
DEFICIENCY)
(X5)
COMPLETION
DATECROSS-REFERENCED TO THE APPROPRIATE
SEYMOUR, IN 47274
152567 01/14/2020
FRESENIUS MEDICAL CARE SEYMOUR
200 E THIRD ST
00
at the QAI Committee meeting
monthly. The Clinical Manager is
responsible to review, analyze and
trend all data and Monitor/Audit
results as related to this Plan of
Correction prior to presenting to
the QAI Committee monthly. The
Director of Operations is
responsible to present the status
of the Plan of Correction and all
other actions taken toward the
resolution of the deficiencies at
each Governing Body meeting
through to the sustained resolution
of all identified issues. The QAI
Committee is responsible to
provide oversight, review findings,
and take actions as appropriate.
The Governing Body is responsible
to provide oversight to ensure the
Plan of Correction, as written to
address the issues identified by
the Statement of Deficiency, is
effective and is providing resolution
of the issues.
Documentation of education,
monitoring, QAI, and Governing
Body is available for review.
The Clinic Manager is responsible
for overall compliance.
494.30(a)(1)(i)
IC-IF TO STATION=DISP/DEDICATE OR
DISINFECT
Items taken into the dialysis station should
either be disposed of, dedicated for use only
on a single patient, or cleaned and
disinfected before being taken to a common
clean area or used on another patient.
-- Nondisposable items that cannot be
V 0116
Bldg. 00
FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: MEIC11 Facility ID: 002497 If continuation sheet Page 9 of 38
-
(X1) PROVIDER/SUPPLIER/CLIA
DEPARTMENT OF HEALTH AND HUMAN SERVICES
CENTERS FOR MEDICARE & MEDICAID SERVICES
02/03/2020PRINTED:
FORM APPROVED
OMB NO. 0938-039
STATEMENT OF DEFICIENCIES
AND PLAN OF CORRECTION IDENTIFICATION NUMBER
(X2) MULTIPLE CONSTRUCTION
A. BUILDING
B. WING
(X3) DATE SURVEY
COMPLETED
NAME OF PROVIDER OR SUPPLIERSTREET ADDRESS, CITY, STATE, ZIP COD
(X4) ID
PREFIX
TAG
SUMMARY STATEMENT OF DEFICIENCIE
(EACH DEFICIENCY MUST BE PRECEDED BY FULL
REGULATORY OR LSC IDENTIFYING INFORMATION
PREFIX
TAG
IDPROVIDER'S PLAN OF CORRECTION
(EACH CORRECTIVE ACTION SHOULD BE
DEFICIENCY)
(X5)
COMPLETION
DATECROSS-REFERENCED TO THE APPROPRIATE
SEYMOUR, IN 47274
152567 01/14/2020
FRESENIUS MEDICAL CARE SEYMOUR
200 E THIRD ST
00
cleaned and disinfected (e.g., adhesive tape,
cloth covered blood pressure cuffs) should be
dedicated for use only on a single patient.
-- Unused medications (including multiple
dose vials containing diluents) or supplies
(syringes, alcohol swabs, etc.) taken to the
patient's station should be used only for that
patient and should not be returned to a
common clean area or used on other
patients.
Based on observation, the facility failed to store
unused equipment off of the dialysis treatment
area countertops for 1 of 1 observation days.
Findings include:
During a flash tour on 1/9/20 at 10:25 a.m.,
observed 6 unused chairside computers located
between each dialysis station with electrical cords
placed on top of the dialysis countertops. At that
time, employee C, a registered nurse, stated the
facility aquired new dialysis machines that
replaced the chairside computers within the last
month and were no longer using the chairside
computers.
On 1/10/20 at 8:00 a.m., employee A, the clinical
manager, was unable to provide any additional
information.
V 0116 Immediate actions taken by the Director of Operations and Clinic
Manager on January 9, 2020
during the survey are as follows:
·6 unused chairside computers
were removed from the back
chase in the hemodialysis station.
The Clinic Manager will educate
and elicit input from relevant staff
by February 1, 2020, on the
expectations and responsibilities
to comply with the following
policies:
·FMS-CS-IC-II-155-116A
Housekeeping Policy
·FMS-CS-IC-II-155-070A
Dialysis Precautions Policy
Emphasis was placed on:
·Disposing unused equipment
promptly.
·Items taken into the dialysis
station should either be disposed
of, dedicated for use only on a
single patient, or cleaned and
disinfected before being taken to a
common clean area or used on
another patient.
·Non-disposable items that
cannot be cleaned and disinfected
02/13/2020 12:00:00AM
FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: MEIC11 Facility ID: 002497 If continuation sheet Page 10 of 38
-
(X1) PROVIDER/SUPPLIER/CLIA
DEPARTMENT OF HEALTH AND HUMAN SERVICES
CENTERS FOR MEDICARE & MEDICAID SERVICES
02/03/2020PRINTED:
FORM APPROVED
OMB NO. 0938-039
STATEMENT OF DEFICIENCIES
AND PLAN OF CORRECTION IDENTIFICATION NUMBER
(X2) MULTIPLE CONSTRUCTION
A. BUILDING
B. WING
(X3) DATE SURVEY
COMPLETED
NAME OF PROVIDER OR SUPPLIERSTREET ADDRESS, CITY, STATE, ZIP COD
(X4) ID
PREFIX
TAG
SUMMARY STATEMENT OF DEFICIENCIE
(EACH DEFICIENCY MUST BE PRECEDED BY FULL
REGULATORY OR LSC IDENTIFYING INFORMATION
PREFIX
TAG
IDPROVIDER'S PLAN OF CORRECTION
(EACH CORRECTIVE ACTION SHOULD BE
DEFICIENCY)
(X5)
COMPLETION
DATECROSS-REFERENCED TO THE APPROPRIATE
SEYMOUR, IN 47274
152567 01/14/2020
FRESENIUS MEDICAL CARE SEYMOUR
200 E THIRD ST
00
will be dedicated for use only on a
single patient.
·Unused medications or
supplies taken to the patient's
station should be used only for
that patient and should not be
returned to a common clean area
or used on other patients.
Effective on February 3, 2020, the
Clinic Manager or designee will
conduct infection control audits
twice daily for 2 weeks, then once
daily for 2 weeks, then five times
weekly for one month, then weekly
for one month utilizing the
Infection Control & Patient
Treatment Monitoring Tool. The
focus will be on preventing
cross-contamination and
discarding unused equipment
promptly. Once 100% compliance
is sustained, monitoring will be
completed per the Quality
Assessment and Performance
Improvement (QAI) calendar with
oversight from the Governing
Body.
The Medical Director will review
the results of audits each month
at the QAI Committee meeting
monthly. The Clinical Manager is
responsible to review, analyze and
trend all data and Monitor/Audit
results as related to this Plan of
Correction prior to presenting to
the QAI Committee monthly. The
Director of Operations is
responsible to present the status
of the Plan of Correction and all
other actions taken toward the
FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: MEIC11 Facility ID: 002497 If continuation sheet Page 11 of 38
-
(X1) PROVIDER/SUPPLIER/CLIA
DEPARTMENT OF HEALTH AND HUMAN SERVICES
CENTERS FOR MEDICARE & MEDICAID SERVICES
02/03/2020PRINTED:
FORM APPROVED
OMB NO. 0938-039
STATEMENT OF DEFICIENCIES
AND PLAN OF CORRECTION IDENTIFICATION NUMBER
(X2) MULTIPLE CONSTRUCTION
A. BUILDING
B. WING
(X3) DATE SURVEY
COMPLETED
NAME OF PROVIDER OR SUPPLIERSTREET ADDRESS, CITY, STATE, ZIP COD
(X4) ID
PREFIX
TAG
SUMMARY STATEMENT OF DEFICIENCIE
(EACH DEFICIENCY MUST BE PRECEDED BY FULL
REGULATORY OR LSC IDENTIFYING INFORMATION
PREFIX
TAG
IDPROVIDER'S PLAN OF CORRECTION
(EACH CORRECTIVE ACTION SHOULD BE
DEFICIENCY)
(X5)
COMPLETION
DATECROSS-REFERENCED TO THE APPROPRIATE
SEYMOUR, IN 47274
152567 01/14/2020
FRESENIUS MEDICAL CARE SEYMOUR
200 E THIRD ST
00
resolution of the deficiencies at
each Governing Body meeting
through to the sustained resolution
of all identified issues. The QAI
Committee is responsible to
provide oversight, review findings,
and take actions as appropriate.
The Governing Body is responsible
to provide oversight to ensure the
Plan of Correction, as written to
address the issues identified by
the Statement of Deficiency, is
effective and is providing resolution
of the issues.
Documentation of education,
monitoring, QAI, and Governing
Body is available for review.
The Clinic Manager is responsible
for overall compliance.
494.30(a)(1)(i)
IC-CLEAN/DIRTY;MED PREP AREA;NO
COMMON CARTS
Clean areas should be clearly designated for
the preparation, handling and storage of
medications and unused supplies and
equipment. Clean areas should be clearly
separated from contaminated areas where
used supplies and equipment are handled.
Do not handle and store medications or clean
supplies in the same or an adjacent area to
that where used equipment or blood samples
are handled.
When multiple dose medication vials are
used (including vials containing diluents),
prepare individual patient doses in a clean
(centralized) area away from dialysis stations
and deliver separately to each patient. Do not
carry multiple dose medication vials from
V 0117
Bldg. 00
FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: MEIC11 Facility ID: 002497 If continuation sheet Page 12 of 38
-
(X1) PROVIDER/SUPPLIER/CLIA
DEPARTMENT OF HEALTH AND HUMAN SERVICES
CENTERS FOR MEDICARE & MEDICAID SERVICES
02/03/2020PRINTED:
FORM APPROVED
OMB NO. 0938-039
STATEMENT OF DEFICIENCIES
AND PLAN OF CORRECTION IDENTIFICATION NUMBER
(X2) MULTIPLE CONSTRUCTION
A. BUILDING
B. WING
(X3) DATE SURVEY
COMPLETED
NAME OF PROVIDER OR SUPPLIERSTREET ADDRESS, CITY, STATE, ZIP COD
(X4) ID
PREFIX
TAG
SUMMARY STATEMENT OF DEFICIENCIE
(EACH DEFICIENCY MUST BE PRECEDED BY FULL
REGULATORY OR LSC IDENTIFYING INFORMATION
PREFIX
TAG
IDPROVIDER'S PLAN OF CORRECTION
(EACH CORRECTIVE ACTION SHOULD BE
DEFICIENCY)
(X5)
COMPLETION
DATECROSS-REFERENCED TO THE APPROPRIATE
SEYMOUR, IN 47274
152567 01/14/2020
FRESENIUS MEDICAL CARE SEYMOUR
200 E THIRD ST
00
station to station.
Do not use common medication carts to
deliver medications to patients. If trays are
used to deliver medications to individual
patients, they must be cleaned between
patients.
Based on observation and record review, the
facility failed to ensure cross contamination did
not occur between patients and clean/ dirty sinks
for 2 of 14 patient observations. (Patients 16 &17)
Findings include:
1. A 1/4/12 policy titled "Dialysis Precautions"
was provided by the clinical manager on 1/10/20 at
10:25 a.m. The policy indicated, but was not
limited to, "Dialysis Precautions will be followed
by all employees with potential exposure to
bloodborne pathogens and other potentially
infectious material (OPIM) in the dialysis setting
... Approach all patients as if they are infectious ...
Approach all supplies and equipment used for a
patient's treatment as if they are contaminated ...
Clean area: An area designated for clean and
unused equipment, supplies and medications ...
Clean areas should be clearly separated from dirty
areas where used supplies, equipment or blood
samples are handled or stored."
2. During an observation on 1/10/20 at 9:25 a.m.,
patient 16's right arm was resting on the clean sink
during dialysis treatment. At 9:32 a.m. patient 16's
right arm and hand was in the clean sink. At 9:35
a.m. patient 16 placed his right arm and hand
across and into the designated clean sink at
station 11. The space between the sink and the
armrest was approximately less than an inch. This
sink was also shared with patient #16.
V 0117 The Clinic Manager will educate and elicit input from relevant staff
by February 1, 2020, on the
expectations and responsibilities
to comply with the following
policy:
·FMS-CS-IC-II-155-070A -
Dialysis Precautions Policy
Emphasis was placed on:
·Ensure cross contamination
does not occur between patients
and clean/ dirty sinks
·Sufficient space will be
dedicated between patient station
and clean / dirty sinks.
·One “dirty sink” will be removed
from between patient station to
reduce cross contamination risk
and increase space in
hemodialysis stations.
Effective on February 3, 2020, the
Clinic Manager or designee will
conduct infection control audits
twice daily for 2 weeks, then once
daily for 2 weeks, then five times
weekly for one month, then weekly
for one month utilizing the
Infection Control & Patient
Treatment Monitoring Tool. The
focus will be on eliminating
cross-contamination risk in the
patient treatment area. Once
100% compliance is sustained,
02/13/2020 12:00:00AM
FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: MEIC11 Facility ID: 002497 If continuation sheet Page 13 of 38
-
(X1) PROVIDER/SUPPLIER/CLIA
DEPARTMENT OF HEALTH AND HUMAN SERVICES
CENTERS FOR MEDICARE & MEDICAID SERVICES
02/03/2020PRINTED:
FORM APPROVED
OMB NO. 0938-039
STATEMENT OF DEFICIENCIES
AND PLAN OF CORRECTION IDENTIFICATION NUMBER
(X2) MULTIPLE CONSTRUCTION
A. BUILDING
B. WING
(X3) DATE SURVEY
COMPLETED
NAME OF PROVIDER OR SUPPLIERSTREET ADDRESS, CITY, STATE, ZIP COD
(X4) ID
PREFIX
TAG
SUMMARY STATEMENT OF DEFICIENCIE
(EACH DEFICIENCY MUST BE PRECEDED BY FULL
REGULATORY OR LSC IDENTIFYING INFORMATION
PREFIX
TAG
IDPROVIDER'S PLAN OF CORRECTION
(EACH CORRECTIVE ACTION SHOULD BE
DEFICIENCY)
(X5)
COMPLETION
DATECROSS-REFERENCED TO THE APPROPRIATE
SEYMOUR, IN 47274
152567 01/14/2020
FRESENIUS MEDICAL CARE SEYMOUR
200 E THIRD ST
00
3. During an observation on 1/10/20 at 9:30 a.m.,
patient 17's left arm was resting on his personal
pillow partially across the clean sink at station 10.
The space between the sink and the armrest was
approximately less than an inch. This sink was
also shared with patient #17.
4. During an interview on 1/10/20 at 12:30 p.m.,
the director of operations and the clinical manager
were unable to provide any additional information.
monitoring will be completed per
the Quality Assessment and
Performance Improvement (QAI)
calendar with oversight from the
Governing Body.
The Medical Director will review
the results of audits each month
at the QAI Committee meeting
monthly. The Clinical Manager is
responsible to review, analyze and
trend all data and Monitor/Audit
results as related to this Plan of
Correction prior to presenting to
the QAI Committee monthly. The
Director of Operations is
responsible to present the status
of the Plan of Correction and all
other actions taken toward the
resolution of the deficiencies at
each Governing Body meeting
through to the sustained resolution
of all identified issues. The QAI
Committee is responsible to
provide oversight, review findings,
and take actions as appropriate.
The Governing Body is responsible
to provide oversight to ensure the
Plan of Correction, as written to
address the issues identified by
the Statement of Deficiency, is
effective and is providing resolution
of the issues.
Documentation of education,
monitoring, QAI, and Governing
Body is available for review.
The Clinic Manager is responsible
for overall compliance.
494.30(a)(4)(ii)
IC-DISINFECT SURFACES/EQUIP/WRITTEN
V 0122
FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: MEIC11 Facility ID: 002497 If continuation sheet Page 14 of 38
-
(X1) PROVIDER/SUPPLIER/CLIA
DEPARTMENT OF HEALTH AND HUMAN SERVICES
CENTERS FOR MEDICARE & MEDICAID SERVICES
02/03/2020PRINTED:
FORM APPROVED
OMB NO. 0938-039
STATEMENT OF DEFICIENCIES
AND PLAN OF CORRECTION IDENTIFICATION NUMBER
(X2) MULTIPLE CONSTRUCTION
A. BUILDING
B. WING
(X3) DATE SURVEY
COMPLETED
NAME OF PROVIDER OR SUPPLIERSTREET ADDRESS, CITY, STATE, ZIP COD
(X4) ID
PREFIX
TAG
SUMMARY STATEMENT OF DEFICIENCIE
(EACH DEFICIENCY MUST BE PRECEDED BY FULL
REGULATORY OR LSC IDENTIFYING INFORMATION
PREFIX
TAG
IDPROVIDER'S PLAN OF CORRECTION
(EACH CORRECTIVE ACTION SHOULD BE
DEFICIENCY)
(X5)
COMPLETION
DATECROSS-REFERENCED TO THE APPROPRIATE
SEYMOUR, IN 47274
152567 01/14/2020
FRESENIUS MEDICAL CARE SEYMOUR
200 E THIRD ST
00
PROTOCOL
[The facility must demonstrate that it follows
standard infection control precautions by
implementing-
(4) And maintaining procedures, in
accordance with applicable State and local
laws and accepted public health procedures,
for the-]
(ii) Cleaning and disinfection of contaminated
surfaces, medical devices, and equipment.
Bldg. 00
Based on observation, record review, and
interview, the facility failed to perform appropriate
hand hygiene after assessing a patient and prior
to cleaning equipment for 2 of 14 patient
observations. (Employee I); and failed to follow
applicable infection control procedures when
cleaning and disinfecting contaminated surfaces
and equipment for 2 of 2 treatment stations being
cleaned. (Station 4 & 10)
Findings include:
1. A 11/4/19 policy titled "Cleaning and
Disinfection of the Dialysis Station" was provided
by the clinical manager on 1/10/20 at 11:30 a.m.
The policy indicated, but was not limited to, "3.
Use a cloth wetted with 1:100 bleach solution or
EPA-approved disinfectant to clean and disinfect
the dialysis station (chair/bed, tables, machine,
television, IV pole, B/P cuff, hand sanitizer
dispenser and holder, etc.) ... clean all surfaces.
Make the surfaces listening wet and allow to air
dry unless otherwise specified by the
manufacturer ... Surface disinfect dialysis wall
boxes and the area/wall around the wall box ...
Special attention should be given to removing
build-up and / or cleaning splatter and spray of
concentrate solution ... "
V 0122 The Clinic Manager will educate and elicit input from relevant staff
by February 1, 2020, on the
expectations and responsibilities
to comply with the following
policies and procedures:
·FMS-CS-IC-II-155-110A
Cleaning and Disinfection of the
Dialysis Station Policy
·FMS- CS- IC- II 155-090A
Hand Hygiene Policy
·FMS-CS-1C-11-155-090C
Hand Hygiene Procedure
·FMS-CS-1C-11-155-123A
Cleaning and Disinfection of
Stethoscope Policy
·FMS-CS-1C-11-155-123C
Cleaning and Disinfection of
Stethoscope Procedure
Education emphasis was placed
on:
·Cleaning and disinfected all
work surfaces within the
hemodialysis station with 1:100
bleach solution after completion of
procedures; ensure the surfaces
are glistening wet and allow to air
dry before placing clean supplies
for the next patient.
·Hand Hygiene using
02/13/2020 12:00:00AM
FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: MEIC11 Facility ID: 002497 If continuation sheet Page 15 of 38
-
(X1) PROVIDER/SUPPLIER/CLIA
DEPARTMENT OF HEALTH AND HUMAN SERVICES
CENTERS FOR MEDICARE & MEDICAID SERVICES
02/03/2020PRINTED:
FORM APPROVED
OMB NO. 0938-039
STATEMENT OF DEFICIENCIES
AND PLAN OF CORRECTION IDENTIFICATION NUMBER
(X2) MULTIPLE CONSTRUCTION
A. BUILDING
B. WING
(X3) DATE SURVEY
COMPLETED
NAME OF PROVIDER OR SUPPLIERSTREET ADDRESS, CITY, STATE, ZIP COD
(X4) ID
PREFIX
TAG
SUMMARY STATEMENT OF DEFICIENCIE
(EACH DEFICIENCY MUST BE PRECEDED BY FULL
REGULATORY OR LSC IDENTIFYING INFORMATION
PREFIX
TAG
IDPROVIDER'S PLAN OF CORRECTION
(EACH CORRECTIVE ACTION SHOULD BE
DEFICIENCY)
(X5)
COMPLETION
DATECROSS-REFERENCED TO THE APPROPRIATE
SEYMOUR, IN 47274
152567 01/14/2020
FRESENIUS MEDICAL CARE SEYMOUR
200 E THIRD ST
00
2. A 11/4 19 policy titled "Hand Hygiene" was
provided by the clinical manager on 1/10/19 at
11:30 a.m. The policy indicated, but was not
limited to, "Hands will be decontaminated using
alcohol-based hand rub or by washing hands with
antimicrobial soap and water before an after direct
contact with patient, entering and leaving the
treatment area, ... Immediately after removing
gloves ... after contact with inanimate objects near
the patient ..."
3. A 1/4/12 policy titled "Cleaning and
Disinfection of the Stethoscope" was provided by
the clinical manager on 1/10/20 at 10:25 a.m. The
policy indicated, but was not limited to, "Mehta,
et al. (2010) ... the advent of alcohol based
handrub as the preferred agent for hand hygiene
and its ubiquitous presence in the hospital led us
to study the effectiveness of combining hand and
stethoscope disinfection in one maneuver that
could be done routinely between patient
examinations."
4. An article titled "Stethoscope Cleaning and
Care,"
https://www.littmann.com/3M/en_US/littmann-ste
thoscopes/my-stethoscope/using-your-stethosco
pe/care/ states, "Do not use hand sanitizer as a
cleaning agent as there are additives that may
damage parts of the stethoscope"
5. The Center for Disease Control and Infection
published an article titled "Disinfection of
Healthcare Equipment" which states, "Medical
equipment surfaces (e.g., blood pressure cuffs,
stethoscopes, hemodialysis machines, and X-ray
machines) can become contaminated with
infectious agents and contribute to the spread of
health-care-associated infections. For this reason,
noncritical medical equipment surfaces should be
alcohol-based hand rub or by
washing hands with antimicrobial
soap and water before and after
direct contact with patient,
entering and leaving the treatment
area, immediately after removing
gloves and, after contact with
inanimate objects near the patient.
·Utilization of an appropriate
EPA disinfectant - registered low
or intermediate – such as alcohol
prep pads, to clean the
stethoscope; hand sanitizer will
not be used as a cleaning agent
as there are additives that may
damage parts of the stethoscope
per manufacturer.
·Surface disinfect dialysis wall
boxes and the area/wall around
the wall boxes; special attention
will be given to removing build-up
and / or cleaning splatter and
spray of concentrate solution.
Effective on February 3, 2020, the
Clinic Manager or designee will
conduct infection control audits
twice daily for 2 weeks, then once
daily for 2 weeks, then five times
weekly for one month, then weekly
for one month utilizing the
Infection Control & Patient
Treatment Monitoring Tool. The
focus will be on cleaning the entire
hemodialysis station and
equipment with an appropriate
EPA disinfectant per policy, hand
hygiene, and prompt removal of
concentrate spray. Once 100%
compliance is sustained,
monitoring will be completed per
FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: MEIC11 Facility ID: 002497 If continuation sheet Page 16 of 38
-
(X1) PROVIDER/SUPPLIER/CLIA
DEPARTMENT OF HEALTH AND HUMAN SERVICES
CENTERS FOR MEDICARE & MEDICAID SERVICES
02/03/2020PRINTED:
FORM APPROVED
OMB NO. 0938-039
STATEMENT OF DEFICIENCIES
AND PLAN OF CORRECTION IDENTIFICATION NUMBER
(X2) MULTIPLE CONSTRUCTION
A. BUILDING
B. WING
(X3) DATE SURVEY
COMPLETED
NAME OF PROVIDER OR SUPPLIERSTREET ADDRESS, CITY, STATE, ZIP COD
(X4) ID
PREFIX
TAG
SUMMARY STATEMENT OF DEFICIENCIE
(EACH DEFICIENCY MUST BE PRECEDED BY FULL
REGULATORY OR LSC IDENTIFYING INFORMATION
PREFIX
TAG
IDPROVIDER'S PLAN OF CORRECTION
(EACH CORRECTIVE ACTION SHOULD BE
DEFICIENCY)
(X5)
COMPLETION
DATECROSS-REFERENCED TO THE APPROPRIATE
SEYMOUR, IN 47274
152567 01/14/2020
FRESENIUS MEDICAL CARE SEYMOUR
200 E THIRD ST
00
disinfected with an EPA-registered low- or
intermediate-level disinfectant. Use of a
disinfectant will provide antimicrobial activity that
is likely to be achieved with minimal additional
cost or work."
6. A janitorial contract titled "2019 RFP Contract
Exhibit A" was provided by the clinical manager
on 1/10/20 at 10:42 a.m. The policy indicated but
was not limited to, "2) Treatment Room, waiting
Room, Offices, Staff Lounge and Hallways ... e)
Daily, dust or, clean with damp or treated cloth ...
cabinets ... counters."
7. During an observation on 1/9/20 at 2:37 p.m.,
observed employee I, a PCT, assess patient 6's left
AV (atrioventricular) access site with her
stethoscope. After assessing patient 6's access
site, while still gloved, applied hand sanitizer on
gloves to disinfect the stethoscope. Employee I
failed to remove gloves and perform hand hygiene
after assessing the patient.
8. During an observation on 1/10/20 at 9:00 a.m.,
observed employee I assess patient 8's left AV
access site with her stethoscope. After assessing
patient 8's access site, employee I ungloved,
applied hand sanitizer onto her hands to disinfect
the stethoscope. Employee I failed to disinfect
medical equipment with an appropriate EPA
disinfectant.
9. During an observation on 1/10/20 at 9:30 a.m.,
observed employee I clean and disinfect station
4's treatment area. Employee I failed to clean the
outer left side of treatment chair, TV screen,
countertop behind the treatment station and white
splatter around water wall outlet. At that time,
clean supplies for the next patient were laid down
on the right arm rest that was still wet. Employee I
the Quality Assessment and
Performance Improvement (QAI)
calendar with oversight from the
Governing Body.
The Medical Director will review
the results of audits each month
at the QAI Committee meeting
monthly. The Clinical Manager is
responsible to review, analyze and
trend all data and Monitor/Audit
results as related to this Plan of
Correction prior to presenting to
the QAI Committee monthly. The
Director of Operations is
responsible to present the status
of the Plan of Correction and all
other actions taken toward the
resolution of the deficiencies at
each Governing Body meeting
through to the sustained resolution
of all identified issues. The QAI
Committee is responsible to
provide oversight, review findings,
and take actions as appropriate.
The Governing Body is responsible
to provide oversight to ensure the
Plan of Correction, as written to
address the issues identified by
the Statement of Deficiency, is
effective and is providing resolution
of the issues.
Documentation of education,
monitoring, QAI, and Governing
Body is available for review.
The Clinic Manager is responsible
for overall compliance.
FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: MEIC11 Facility ID: 002497 If continuation sheet Page 17 of 38
-
(X1) PROVIDER/SUPPLIER/CLIA
DEPARTMENT OF HEALTH AND HUMAN SERVICES
CENTERS FOR MEDICARE & MEDICAID SERVICES
02/03/2020PRINTED:
FORM APPROVED
OMB NO. 0938-039
STATEMENT OF DEFICIENCIES
AND PLAN OF CORRECTION IDENTIFICATION NUMBER
(X2) MULTIPLE CONSTRUCTION
A. BUILDING
B. WING
(X3) DATE SURVEY
COMPLETED
NAME OF PROVIDER OR SUPPLIERSTREET ADDRESS, CITY, STATE, ZIP COD
(X4) ID
PREFIX
TAG
SUMMARY STATEMENT OF DEFICIENCIE
(EACH DEFICIENCY MUST BE PRECEDED BY FULL
REGULATORY OR LSC IDENTIFYING INFORMATION
PREFIX
TAG
IDPROVIDER'S PLAN OF CORRECTION
(EACH CORRECTIVE ACTION SHOULD BE
DEFICIENCY)
(X5)
COMPLETION
DATECROSS-REFERENCED TO THE APPROPRIATE
SEYMOUR, IN 47274
152567 01/14/2020
FRESENIUS MEDICAL CARE SEYMOUR
200 E THIRD ST
00
failed to allow the treatment chair and armrest to
dry before laying clean supplies down for the next
patient.
10. During an interview on 1/10/20 at 12:30 p.m.,
the Administrator and clinical manager
acknowledged that facility policies were not
followed.
11. During an observation on 1/13/20 at 11:25 a.m.,
observed employee G clean and disinfect station
10's treatment area. Employee G failed to clean the
countertop behind the treatment station and failed
to disinfect the TV prior to another PCT setting
clean supplies down at station 10 for the next
patient. Employee E failed to allow the treatment
chair and armrest to dry before laying down clean
supplies for the next patient.
12. During exit conference on 1/14/20 at 12:30 p.m.,
the director of operations and clinical manager
provided no additional information for review.
494.60
CFC-PHYSICAL ENVIRONMENT
V 0400
Bldg. 00
Based on observation, record review, and
interview the facility failed to ensure the physical
environment was safe, comfortable and functional
to prevent microbial growth, cross contamination,
and maintain infection control (See Tag V401);
failed to ensure the building construction was
maintained for safety to prevent falls risks and
infection risk (See Tag V402); failed to ensure
there was sufficient space to prevent cross
contamination between clean and dirty areas (See
Tag V404) and failed to ensure the facility was
able to accommodate patient privacy when
V 0400 The Governing Body of this facility acknowledges its responsibility to
ensure all staff follow approved
policies and procedures for
physical environment and continue
to develop, analyze and revise
action plans regarding physical
environment concerns to ensure
ongoing compliance.
The Governing Body met on
January 29, 2020 and reviewed the
Statement of Deficiencies and
developed the following Plan of
Correction ensuring that
02/13/2020 12:00:00AM
FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: MEIC11 Facility ID: 002497 If continuation sheet Page 18 of 38
-
(X1) PROVIDER/SUPPLIER/CLIA
DEPARTMENT OF HEALTH AND HUMAN SERVICES
CENTERS FOR MEDICARE & MEDICAID SERVICES
02/03/2020PRINTED:
FORM APPROVED
OMB NO. 0938-039
STATEMENT OF DEFICIENCIES
AND PLAN OF CORRECTION IDENTIFICATION NUMBER
(X2) MULTIPLE CONSTRUCTION
A. BUILDING
B. WING
(X3) DATE SURVEY
COMPLETED
NAME OF PROVIDER OR SUPPLIERSTREET ADDRESS, CITY, STATE, ZIP COD
(X4) ID
PREFIX
TAG
SUMMARY STATEMENT OF DEFICIENCIE
(EACH DEFICIENCY MUST BE PRECEDED BY FULL
REGULATORY OR LSC IDENTIFYING INFORMATION
PREFIX
TAG
IDPROVIDER'S PLAN OF CORRECTION
(EACH CORRECTIVE ACTION SHOULD BE
DEFICIENCY)
(X5)
COMPLETION
DATECROSS-REFERENCED TO THE APPROPRIATE
SEYMOUR, IN 47274
152567 01/14/2020
FRESENIUS MEDICAL CARE SEYMOUR
200 E THIRD ST
00
providing treatment to patients (See Tag V406).
The cumulative effect of this systemic problem
resulted in the facility being out of compliance
with the Condition for Coverage 42 CFR 494.60
Physical Environment.
deficiencies are addressed, both
immediately and with long term
resolution.
The Governing Body began
meeting weekly beginning on
February 3, 2020, to monitor the
progress of the Plan of Correction
ensuring that deficiencies are
addressed, both immediately and
with long term resolution. The
Governing Body will determine
when the frequency of these
meetings may be reduced to the
regular quarterly schedule.
Effective immediately:
·The Clinical Manager will
analyze and trend all data and
monitor/audit results as related to
this Plan of Correction prior to
presenting the monthly data to the
QAI Committee.
·A specific plan of action
encompassing the citations as
cited in the Statement of
Deficiency has been added to the
facility’s monthly QAI (Quality
Assessment and Performance
Improvement) agenda.
·The QAI Committee is
responsible to review and evaluate
the Plan of Correction to ensure it
is effective and is providing
resolution of the issues.
·The Director of Operations (DO)
will present a report on the Plan of
Correction data and all actions
taken toward the resolution of the
deficiencies at each Governing
Body meeting through to the
sustained resolution of all
FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: MEIC11 Facility ID: 002497 If continuation sheet Page 19 of 38
-
(X1) PROVIDER/SUPPLIER/CLIA
DEPARTMENT OF HEALTH AND HUMAN SERVICES
CENTERS FOR MEDICARE & MEDICAID SERVICES
02/03/2020PRINTED:
FORM APPROVED
OMB NO. 0938-039
STATEMENT OF DEFICIENCIES
AND PLAN OF CORRECTION IDENTIFICATION NUMBER
(X2) MULTIPLE CONSTRUCTION
A. BUILDING
B. WING
(X3) DATE SURVEY
COMPLETED
NAME OF PROVIDER OR SUPPLIERSTREET ADDRESS, CITY, STATE, ZIP COD
(X4) ID
PREFIX
TAG
SUMMARY STATEMENT OF DEFICIENCIE
(EACH DEFICIENCY MUST BE PRECEDED BY FULL
REGULATORY OR LSC IDENTIFYING INFORMATION
PREFIX
TAG
IDPROVIDER'S PLAN OF CORRECTION
(EACH CORRECTIVE ACTION SHOULD BE
DEFICIENCY)
(X5)
COMPLETION
DATECROSS-REFERENCED TO THE APPROPRIATE
SEYMOUR, IN 47274
152567 01/14/2020
FRESENIUS MEDICAL CARE SEYMOUR
200 E THIRD ST
00
identified issues.
·The Governing Body, at its
meeting of January 29, 2020,
designated the Director of
Operations (DO) to serve as Plan
of Correction Monitor and provide
additional oversight. They will
participate in QAPI and Governing
Body meetings. This additional
oversight is to ensure the ongoing
correction of deficiencies cited in
the Statement of Deficiency
through to resolution as well as
ensure the Governance of the
Facility is presented current and
complete data to enhance their
governance oversight role.
Minutes of the Governing Body
and QAI meetings, as well as
monitoring forms and educational
documentation will provide
evidence of these actions, the
Governing Body’s direction and
oversight and the QAI Committees
ongoing monitoring of facility
activities. These are available for
review at the facility.
The responses provided for V401,
V402, V404 and V406 describe, in
detail, the processes and
monitoring steps taken to ensure
that all deficiencies as cited within
this Condition are corrected to
ensure ongoing compliance.
494.60
PE-SAFE/FUNCTIONAL/COMFORTABLE
ENVIRONMENT
The dialysis facility must be designed,
constructed, equipped, and maintained to
V 0401
Bldg. 00
FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: MEIC11 Facility ID: 002497 If continuation sheet Page 20 of 38
-
(X1) PROVIDER/SUPPLIER/CLIA
DEPARTMENT OF HEALTH AND HUMAN SERVICES
CENTERS FOR MEDICARE & MEDICAID SERVICES
02/03/2020PRINTED:
FORM APPROVED
OMB NO. 0938-039
STATEMENT OF DEFICIENCIES
AND PLAN OF CORRECTION IDENTIFICATION NUMBER
(X2) MULTIPLE CONSTRUCTION
A. BUILDING
B. WING
(X3) DATE SURVEY
COMPLETED
NAME OF PROVIDER OR SUPPLIERSTREET ADDRESS, CITY, STATE, ZIP COD
(X4) ID
PREFIX
TAG
SUMMARY STATEMENT OF DEFICIENCIE
(EACH DEFICIENCY MUST BE PRECEDED BY FULL
REGULATORY OR LSC IDENTIFYING INFORMATION
PREFIX
TAG
IDPROVIDER'S PLAN OF CORRECTION
(EACH CORRECTIVE ACTION SHOULD BE
DEFICIENCY)
(X5)
COMPLETION
DATECROSS-REFERENCED TO THE APPROPRIATE
SEYMOUR, IN 47274
152567 01/14/2020
FRESENIUS MEDICAL CARE SEYMOUR
200 E THIRD ST
00
provide dialysis patients, staff, and the public
a safe, functional, and comfortable treatment
environment.
Based on observation, record review, and
interview, the facility failed to ensure the building
was free from defects and hazards that would
prevent risks for trips and falls; failed to ensure
functionality of the facility equipment; failed to
ensure a comfortable environment providing
sufficient space for privacy; and failed to ensure
there were no areas that would pose infection
control risks for 4 of the 4 days observed.
Findings Include:
1. A 1/4/12 policy titled "Dialysis Precautions"
was provided by the clinical manager on 1/10/20 at
10:25 a.m. The policy indicated, but was not
limited to, "Dialysis Precautions will be followed
by all employees with potential exposure to
bloodborne pathogens and other potentially
infectious material (OPIM) in the dialysis setting
... Approach all patients as if they are infectious ...
Approach all supplies and equipment used for a
patient's treatment as if they are contaminated ...
Clean area: An area designated for clean and
unused equipment, supplies and medications ...
Clean areas should be clearly separated from dirty
areas where used supplies, equipment or blood
samples are handled or stored."
2. A 11/4/19 policy titled "Hand Hygiene" was
provided by the clinical manager on 1/10/20 at
10:25 a.m. The policy indicated, but was not
limited to, "A sufficient number of sinks with soap
and plumbed with both hot and cold water shall
be available to facilitate hand hygiene."
3. A janitorial contract titled "2019 RFP Contract
V 0401 Immediate actions taken by Director of Operations, Clinic
Manager, and the Area Technical
Operations Manager on January
9th – 10th, 2020, during the survey
are as follows:
·Plumbing contractors notified
and repairs to water temperature
for hand sinks completed on
1/10/2020
·Cove basing repaired on
1/9/2020
·Computers from counter chase
removed on 1/9/2020
The Clinic Manager will educate
and elicit input from relevant staff
by February 1, 2020, the
expectations and responsibilities
to comply with the following
policies and procedures:
·FMS-CS-IC-II-155-070A
Dialysis Precautions Policy
·FMS-CS-IC-II-155-116A
Housekeeping Policy
·FMS- CS- IC- II 155-090A
Hand Hygiene Policy
·FMS-CS-1C-11-155-090C
Hand Hygiene Procedure
·FMS-CS-IC-I-101-001A Quality
Assessment and Performance
Improvement Program (QAPI)
Policy
·FMS-CS-IC-I-105-030C
Guidelines for Setting up the
Individual Dialysis Machine Prior
to Hemodialysis Treatment
Procedure
02/13/2020 12:00:00AM
FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: MEIC11 Facility ID: 002497 If continuation sheet Page 21 of 38
-
(X1) PROVIDER/SUPPLIER/CLIA
DEPARTMENT OF HEALTH AND HUMAN SERVICES
CENTERS FOR MEDICARE & MEDICAID SERVICES
02/03/2020PRINTED:
FORM APPROVED
OMB NO. 0938-039
STATEMENT OF DEFICIENCIES
AND PLAN OF CORRECTION IDENTIFICATION NUMBER
(X2) MULTIPLE CONSTRUCTION
A. BUILDING
B. WING
(X3) DATE SURVEY
COMPLETED
NAME OF PROVIDER OR SUPPLIERSTREET ADDRESS, CITY, STATE, ZIP COD
(X4) ID
PREFIX
TAG
SUMMARY STATEMENT OF DEFICIENCIE
(EACH DEFICIENCY MUST BE PRECEDED BY FULL
REGULATORY OR LSC IDENTIFYING INFORMATION
PREFIX
TAG
IDPROVIDER'S PLAN OF CORRECTION
(EACH CORRECTIVE ACTION SHOULD BE
DEFICIENCY)
(X5)
COMPLETION
DATECROSS-REFERENCED TO THE APPROPRIATE
SEYMOUR, IN 47274
152567 01/14/2020
FRESENIUS MEDICAL CARE SEYMOUR
200 E THIRD ST
00
Exhibit A" was provided by the clinical manger on
1/10/20 at 10:42 a.m. The policy indicated, but was
not limited to, " c) Report leaking faucets, clogged
drains, or any other maintenance type problems to
appropriate party ..."
4. A document titled "Seymour QAI [Quality
Assessment Information] Meeting Minutes for
August 2019" provided on 1/10/20 at 7:35 a.m. by
the clinical manager evidenced "Tiles need
replaced, parking lot, transducer with blood,
gloves not worn setting up machines" with no
evidence of a plan implementation or a goal of
completion date.
5. A document titled "Seymour QAI Meeting
Minutes for September 2019" provided on 1/10/20
at 7:35 a.m. by the clinical manager evidenced
"Floor tiles station 11 & 12 need replaced, lawyer
to get trailers moved out of parking lot, redo
parking lots" with no evidence of a plan of
implementation or a goal of completion date.
6. A document titled "Meeting Minutes" provided
on 1/10/20 at 7:35 a.m. by the clinical manager
titled "QAI meeting minutes for November"
evidenced "Audit-still need floors fixed, light in
parking lot and needs repaved" with no evidence
of a plan implementation or a goal of completion
date.
7. During observation on the flash tour on 1/9/20
at 10:30 a.m. evidenced chipped tiles between
station 1 and 2, 11 and station 12, and near central
desk. Dirty grout evidenced in between tiles, rust
between tiles at station 11 and station 12, chipped
paint on walls of treatment room, trash on the
floor near station 5, 6 computers no longer in use
hanging over patients counters with multiple
wires dangling and covered in dust. Stained
·FMS-CS-IC-I-103-005A Patient
Rights and Responsibility Policy
Education emphasis was placed
on:
·Improved process to
communicate physical plant
issues during QAPI process to
include evidence of plan
implementation and a goal of
completion date.
·Ensuring the building was free
from defects and hazards that
would prevent risks for trips and
falls; notified City of Seymour on
1/29/2020 with a commitment from
them to fix parking lot and
sidewalk entrances.
·Infection control practices for
hemodialysis units; promotion of
hand hygiene with hot and cold
water available at all handwashing
sinks; requirement to use gloves
while setting up the hemodialysis
machine; prompt removal of all
trash on the floor.
·New hot water heater installed
on 1/19/20 with direct feed to all
handwashing sinks.
·Ensuring there are no areas
that would pose infection control
risks; sufficient space will be
dedicated between patient station
and clean / dirty sinks; one “dirty
sink” will be removed to improve
patient comfort while on treatment;
5 patient TV’s will be moved to
increase space in hemodialysis
stations.
·Maintaining functionality of the
facility equipment; prompt repairs
FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: MEIC11 Facility ID: 002497 If continuation sheet Page 22 of 38
-
(X1) PROVIDER/SUPPLIER/CLIA
DEPARTMENT OF HEALTH AND HUMAN SERVICES
CENTERS FOR MEDICARE & MEDICAID SERVICES
02/03/2020PRINTED:
FORM APPROVED
OMB NO. 0938-039
STATEMENT OF DEFICIENCIES
AND PLAN OF CORRECTION IDENTIFICATION NUMBER
(X2) MULTIPLE CONSTRUCTION
A. BUILDING
B. WING
(X3) DATE SURVEY
COMPLETED
NAME OF PROVIDER OR SUPPLIERSTREET ADDRESS, CITY, STATE, ZIP COD
(X4) ID
PREFIX
TAG
SUMMARY STATEMENT OF DEFICIENCIE
(EACH DEFICIENCY MUST BE PRECEDED BY FULL
REGULATORY OR LSC IDENTIFYING INFORMATION
PREFIX
TAG
IDPROVIDER'S PLAN OF CORRECTION
(EACH CORRECTIVE ACTION SHOULD BE
DEFICIENCY)
(X5)
COMPLETION
DATECROSS-REFERENCED TO THE APPROPRIATE
SEYMOUR, IN 47274
152567 01/14/2020
FRESENIUS MEDICAL CARE SEYMOUR
200 E THIRD ST
00
ceiling tiles were present throughout the facility,
including but not limited to, the treatment area, the
biomed room, and the acid room. The baseboard
liner was disconnected from the wall and laying
on the floor behind station 6.
8. During an observation on 1/10/20 at 9:25 a.m.
patient 16's right arm was resting on the clean sink
during dialysis treatment. At 9:32 a.m. patient 16's
right arm and hand was in the clean sink. At 9:35
a.m. patient 16 placed his right arm and hand
across and into the designated clean sink at
station 11. The space between the sink and the
armrest was approximately less than an inch. This
sink was also shared with patient #17.
9. During an observation on 1/10/20 at 9:30 a.m.
patient 17's left arm was resting on his personal
pillow partially across the clean sink at station 10.
The space between the sink and the armrest was
approximately less than an inch. This sink was
also shared with patient #16.
10. During an interview on 1/10/20 at 12:30 p.m.
the director of operations and the Clinical
Manager were unable to provide any additional
information.
11. During an observation on 1/9/20 at 11:40 a.m.
the employee restroom sink failed to be plumbed
with hot water.
12. During an observation on 1/10/20 at 8:00 a.m.
the employee restroom sink failed to be plumbed
with hot water.
13. During an observation on 1/10/20 at 8:30 a.m. 2
sinks, made available for patients to wash their
access sites prior to treatment and their hands
after treatment, failed to be plumbed with hot
or removal when indicated; new
floor covering installation for the
clinic was scheduled on 1/31/20
and will remedy cracks in tiles;
prompt replacement of all stained
ceiling tiles; chipped paint in
patient treatment room scheduled
for repair on 1/31/20.
·Ensuring a comfortable
environment providing sufficient
space for privacy; new patient
privacy screens to be utilized.
Effective on February 3, 2020, the
Bio-medical Technician or
designee will conduct physical
plant audits five times weekly for
one month, then two times weekly
for one month, then weekly for one
month utilizing the Physical
Environment Monitoring Tool. The
focus will be on maintaining an
environment free of defects &
hazards, maintaining functional
equipment, dedicated privacy
space, and infection control.
Once 100% compliance is
sustained, monitoring will be
completed per the Quality
Assessment and Performance
Improvement (QAI) calendar with
oversight from the Governing
Body.
The Medical Director will review
the results of audits each month
at the QAI Committee meeting
monthly. The Clinical Manager is
responsible to review, analyze and
trend all data and Monitor/Audit
results as related to this Plan of
Correction prior to presenting to
FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: MEIC11 Facility ID: 002497 If continuation sheet Page 23 of 38
-
(X1) PROVIDER/SUPPLIER/CLIA
DEPARTMENT OF HEALTH AND HUMAN SERVICES
CENTERS FOR MEDICARE & MEDICAID SERVICES
02/03/2020PRINTED:
FORM APPROVED
OMB NO. 0938-039
STATEMENT OF DEFICIENCIES
AND PLAN OF CORRECTION IDENTIFICATION NUMBER
(X2) MULTIPLE CONSTRUCTION
A. BUILDING
B. WING
(X3) DATE SURVEY
COMPLETED
NAME OF PROVIDER OR SUPPLIERSTREET ADDRESS, CITY, STATE, ZIP COD
(X4) ID
PREFIX
TAG
SUMMARY STATEMENT OF DEFICIENCIE
(EACH DEFICIENCY MUST BE PRECEDED BY FULL
REGULATORY OR LSC IDENTIFYING INFORMATION
PREFIX
TAG
IDPROVIDER'S PLAN OF CORRECTION
(EACH CORRECTIVE ACTION SHOULD BE
DEFICIENCY)
(X5)
COMPLETION
DATECROSS-REFERENCED TO THE APPROPRIATE
SEYMOUR, IN 47274
152567 01/14/2020
FRESENIUS MEDICAL CARE SEYMOUR
200 E THIRD ST
00
water.
14. During an interview on 1/10/20 at 8:45 a.m. the
clinical manager stated they were aware of the
sinks not having hot water and it was due to the
distance from the sinks to the hot water heater.
At 8:49 a.m. the clinical manager provided a copy
of an estimate to fix the hot water issue. At 10:42
a.m. the clinical manager stated employee O,
regional Bio-Med technician, was able to flip a
switch and hot water began to recirculate to the
sinks.
15. During an observation on 1/14/20 at 9:40 a.m.
employee E, a PCT (Patient Care Technician),
performed exit site care on patient 19. Employee E
lifted patient 19's shirt to get better access to exit
site exposing the full left breast and partial right
breast in an open treatment area with no privacy
screen provided. Employee E then applied a
barrier pad to the patient and clipped it to the
patient's shirt collar covering the left breast
leaving the right breast partially exposed. The left
breast remained partially exposed until employee
D, an RN (Registered Nurse), covered it at 10:25
a.m. when responding the patient's dialysis alarm.
The staff failed to maintain the patient's right to
privacy and the patient's breast remained exposed
for 45 minutes.
16. During an interview on 01/14/20 with the
clinical manager and the director of operations
they acknowledged that patient 19's privacy was
not protected.
the QAI Committee monthly. The
Director of Operations is
responsible to present the status
of the Plan of Correction and all
other actions taken toward the
resolution of the deficiencies at
each Governing Body meeting
through to the sustained resolution
of all identified issues. The QAI
Committee is responsible to
provide oversight, review findings,
and take actions as appropriate.
The Governing Body is responsible
to provide oversight to ensure the
Plan of Correction, as written to
address the issues identified by
the Statement of Deficiency, is
effective and is providing resolution
of the issues.
Documentation of education,
monitoring, QAI, and Governing
Body is available for review.
The Clinic Manager is responsible
for overall compliance.
494.60(a)
PE-BUILDING-CONSTRUCT/MAINTAIN FOR
SAFETY
The building in which dialysis services are
furnished must be constructed and
V 0402
Bldg. 00
FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: MEIC11 Facility ID: 002497 If continuation sheet Page 24 of 38
-
(X1) PROVIDER/SUPPLIER/CLIA
DEPARTMENT OF HEALTH AND HUMAN SERVICES
CENTERS FOR MEDICARE & MEDICAID SERVICES
02/03/2020PRINTED:
FORM APPROVED
OMB NO. 0938-039
STATEMENT OF DEFICIENCIES
AND PLAN OF CORRECTION IDENTIFICATION NUMBER
(X2) MULTIPLE CONSTRUCTION
A. BUILDING
B. WING
(X3) DATE SURVEY
COMPLETED
NAME OF PROVIDER OR SUPPLIERSTREET ADDRESS, CITY, STATE, ZIP COD
(X4) ID
PREFIX
TAG
SUMMARY STATEMENT OF DEFICIENCIE
(EACH DEFICIENCY MUST BE PRECEDED BY FULL
REGULATORY OR LSC IDENTIFYING INFORMATION
PREFIX
TAG
IDPROVIDER'S PLAN OF CORRECTION
(EACH CORRECTIVE ACTION SHOULD BE
DEFICIENCY)
(X5)
COMPLETION
DATECROSS-REFERENCED TO THE APPROPRIATE
SEYMOUR, IN 47274
152567 01/14/2020
FRESENIUS MEDICAL CARE SEYMOUR
200 E THIRD ST
00
maintained to ensure the safety of the
patients, the staff and the public.
Based on observation, record review, and
interview, the facility failed to maintain systems
effectively free from defects and hazards to ensure
safety and functionality in 1 of 1 facility observed.
Findings include:
1. A 2018 policy titled "Equipment Installation,
Operation, Maintenance, Repair, & Disposal"
provided on 1/10/20 at 11:30 a.m. by the clinical
manager that indicated, but was not limited to, " ...
This includes ... Concentrate Production and
Delivery Equipment ... HVAC systems ... Physical
Plant (ceilings, floors etc.) ... For medical
equipment, perform external and internal
disinfection as required by policy...any equipment
or device that is not fully functioning ... must be
repaired or replaced as soon as reasonably
possible ... identified issues may include fluid
leaks ... broken or misadjusted parts ... or aesthetic
damages."
2. A janitorial contract titled "2019 RFP Contract
Exhibit A" provided on 1/10/20 at 10:42 a.m. by the
clinical manager that indicates, but is not limited
to, " 2) Treatment Room, Waiting Room, Offices,
Staff Lounges, and Hallways ... e. Daily, dust or,
clean with damp or treated cloth furniture, fixtures,
telephones, cabinets, files, and counters...4) Entire
Facility a) Monthly, dust and clean all air vents... "
3. A document titled "Seymour QAI Meeting
Minutes for August 2019" provided on 1/10/20 at
7:35 a.m. by the clinical manager evidenced "Tiles
need replaced, parking lot, transducer with blood,
gloves not worn setting up machines" with no
evidence of a plan for implementation or goal of
V 0402 Immediate actions taken by Director of Operations, Clinic
Manager, and the Area Technical
Operations Manager on January
9th – 13th, 2020, during the survey
are as follows:
·Cove basing repaired,
computers from counter chase,
and IV poles replaced on
1/9/2020
·HVAC Vent replacement holes
and cracks in drywall repaired on
1/9/2020
·Wood from pallet was removed
on 1/9/20; additional review of
findings revealed wood was not
from ceiling.
·Scheduled repairs for drywall
crack above bicarb tank to be
completed by 1/13/20
The Clinic Manager will educate
and elicit input from relevant staff
by February 1, 2020, the
expectations and responsibilities
to comply with the following
policies and procedures:
·FMS-CS-IC-II-155-116A
Housekeeping Policy
·FMS-CS-IC-I-101-001A Quality
Assessment and Performance
Improvement Program (QAPI)
Policy
·FKC-0000-102 Equipment
Installation, Operation,
Maintenance, Repair and Disposal
Education emphasis was placed
on:
·Improved process to
02/13/2020 12:00:00AM
FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: MEIC11 Facility ID: 002497 If continuation sheet Page 25 of 38
-
(X1) PROVIDER/SUPPLIER/CLIA
DEPARTMENT OF HEALTH AND HUMAN SERVICES
CENTERS FOR MEDICARE & MEDICAID SERVICES
02/03/2020PRINTED:
FORM APPROVED
OMB NO. 0938-039
STATEMENT OF DEFICIENCIES
AND PLAN OF CORRECTION IDENTIFICATION NUMBER
(X2) MULTIPLE CONSTRUCTION
A. BUILDING
B. WING
(X3) DATE SURVEY
COMPLETED
NAME OF PROVIDER OR SUPPLIERSTREET ADDRESS, CITY, STATE, ZIP COD
(X4) ID
PREFIX
TAG
SUMMARY STATEMENT OF DEFICIENCIE
(EACH DEFICIENCY MUST BE PRECEDED BY FULL
REGULATORY OR LSC IDENTIFYING INFORMATION
PREFIX
TAG
IDPROVIDER'S PLAN OF CORRECTION
(EACH CORRECTIVE ACTION SHOULD BE
DEFICIENCY)
(X5)
COMPLETION
DATECROSS-REFERENCED TO THE APPROPRIATE
SEYMOUR, IN 47274
152567 01/14/2020
FRESENIUS MEDICAL CARE SEYMOUR
200 E THIRD ST
00
completion date.
A document titled, Seymour QAI Meeting
Minutes for September 2019, provided on 1/10/20
at 7:35 a.m. by the clinical manager evidenced
"Floor tiles station 11 & 12 need replaced, lawyer
to get trailers moved out of parking lot, redo
parking lots" with no evidence of a plan for
implementation or goal of completion date..
A document titled "Meeting Minutes" provided
on 1/10/20 at 7:35 a.m. by the clinical manager.
QAI meeting minutes for November evidenced,
"Audit-still need floors fixed, light in parking lot
and needs repaved" with no evidence of a plan for
implementation or goal of completion date.
4. Observation during the flash tour on 1/9/20 at
10:30 a.m. evidenced chipped tiles between station
1 and 2, 11 and station 12, and near central desk.
Dirty grout evidenced in between tiles, rust
between tiles at station 11 and station 12, chipped
paint on walls of treatment room, trash on the
floor near station 5, and 6 computers, no longer in
use, hanging over patients counters with multiple
wires dangling and covered in dust. Stained
ceiling tiles were present throughout the facility,
including, but not limited to, the treatment area,
the biomed room, and the acid room. The
baseboard liner was disconnected from the wall
and laying on the floor behind station 6.
5. Observation of the storage room on 1/9/20 at
11:00 a.m. evidenced the HVAC (Heating,
Ventilation, and Air Conditioning) system covered
in a thick layer of dust, rust on the exterior ducts
of the HVAC system, 2 holes the size of a
basketball in the wall, wood fallen from the ceiling
and laying on the floor near the exit door.
communicate physical plant
issues during QAPI; process to
include evidence of plan
implementation and a goa