printed: 02/03/2020 department of health and human ... · tag id provider's plan of correction...

(X1) PROVIDER/SUPPLIER/CLIA

DEPARTMENT OF HEALTH AND HUMAN SERVICES

CENTERS FOR MEDICARE & MEDICAID SERVICES

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STATEMENT OF DEFICIENCIES

AND PLAN OF CORRECTION IDENTIFICATION NUMBER

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NAME OF PROVIDER OR SUPPLIERSTREET ADDRESS, CITY, STATE, ZIP COD

(X4) ID

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SUMMARY STATEMENT OF DEFICIENCIE

(EACH DEFICIENCY MUST BE PRECEDED BY FULL

REGULATORY OR LSC IDENTIFYING INFORMATION

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TAG

IDPROVIDER'S PLAN OF CORRECTION

(EACH CORRECTIVE ACTION SHOULD BE

DEFICIENCY)

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DATECROSS-REFERENCED TO THE APPROPRIATE

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E 0000

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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

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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

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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

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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

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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





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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

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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.

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... 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.


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


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





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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

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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


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




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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 ..."


the employee restroom sink failed to be plumbed

with hot water.



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.


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


·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.










focus will be on all hand washing

sinks to have hot and cold water.







Body.







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of the issues.






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

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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.






policies:


Housekeeping Policy




·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

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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.










focus will be on preventing

cross-contamination and

discarding unused equipment

promptly. Once 100% compliance

is sustained, monitoring will be





Body.


















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of the issues.






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

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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:

























V 0117 The Clinic Manager will educate and elicit input from relevant staff




policy:

·FMS-CS-IC-II-155-070A -



·Ensure cross contamination

does not occur between patients

and clean/ dirty sinks

·Sufficient space will be


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.










focus will be on eliminating

cross-contamination risk in the

patient treatment area. Once

100% compliance is sustained,

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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.



























of the issues.






494.30(a)(4)(ii)

IC-DISINFECT SURFACES/EQUIP/WRITTEN

V 0122





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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


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




policies and procedures:


Cleaning and Disinfection of the

Dialysis Station Policy


Hand Hygiene Policy

·FMS-CS-1C-11-155-090C


·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

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2. A 11/4 19 policy titled "Hand Hygiene" was



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.










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





02/03/2020PRINTED:

FORM APPROVED

OMB NO. 0938-039




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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."


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.


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.


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.



























of the issues.










02/03/2020PRINTED:

FORM APPROVED

OMB NO. 0938-039




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failed to allow the treatment chair and armrest to

dry before laying clean supplies down for the next

patient.


the Administrator and clinical manager

acknowledged that facility policies were not

followed.


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


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





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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


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





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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





02/03/2020PRINTED:

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provide dialysis patients, staff, and the public

a safe, functional, and comfortable treatment

environment.


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:
















2. A 11/4/19 policy titled "Hand Hygiene" was



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 0401 Immediate actions taken by Director of Operations, Clinic

Manager, and the Area Technical


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



by February 1, 2020, the







Housekeeping Policy


Hand Hygiene Policy

·FMS-CS-1C-11-155-090C


·FMS-CS-IC-I-101-001A Quality


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





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OMB NO. 0938-039




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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


on:



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


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





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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.















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.



with hot water.



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.


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.







Body.













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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.


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.



















of the issues.






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





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maintained to ensure the safety of the

patients, the staff and the public.


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."


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


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



by February 1, 2020, the





Housekeeping Policy

·FMS-CS-IC-I-101-001A Quality


Improvement Program (QAPI)

Policy

·FKC-0000-102 Equipment

Installation, Operation,

Maintenance, Repair and Disposal


on:


02/13/2020 12:00:00AM





02/03/2020PRINTED:

FORM APPROVED

OMB NO. 0938-039




A. BUILDING

B. WING

(X3) DATE SURVEY

COMPLETED


(X4) ID

PREFIX

TAG




PREFIX

TAG



DEFICIENCY)

(X5)

COMPLETION


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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.


issues during QAPI; process to

include evidence of plan

implementation and a goa

printed: 02/03/2020 department of health and human ... · tag id provider's plan of correction...

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